## Protocol Section
### Identification Module
**NCT ID:** NCT03236779

**Brief Title:** A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain

**Official Title:** A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain: A Randomized Clinical Trial

#### Organization Study ID Info
**ID:** ALBOLOUSHI
#### Organization
**Class:** OTHER
**Full Name:** Universidad de Zaragoza
### Status Module
#### Completion Date
**Date:** 2019-12-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-26

**Type:** ACTUAL

**Last Update Submit Date:** 2021-01-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-10-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-01-26

**Type:** ACTUAL

**Results First Submit Date:** 2020-07-30

**Results First Submit QC Date:** 2021-01-23

#### Start Date
**Date:** 2018-01-14

**Type:** ACTUAL

**Status Verified Date:** 2021-01

#### Study First Post Date
**Date:** 2017-08-02
**Type:** ACTUAL
**Study First Submit Date:** 2017-07-25
**Study First Submit QC Date:** 2017-08-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Universidad San Jorge

**Class:** OTHER_GOV

**Name:** Ministry of Health, Kuwait

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidad de Zaragoza

#### Responsible Party

**Investigator Affiliation:** Universidad de Zaragoza

**Investigator Full Name:** ZAID AL BOLOUSHI

**Investigator Title:** PhD student

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a clinical trial that will be done in the state of Kuwait, at the physical rehabilitation medicine hospital. the participants will be recruited from all over Kuwait, there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of health.

**Detailed Description:** Physical therapy approaches continue evolving. During the last years, minimally invasive techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining promising results for tendon pathology. PNE technique is a minimally invasive treatment that consists of an application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. This allows for phagocytosis and the subsequent regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to manage MTrP, but there are no studies supporting that they have an additional beneficial effect over DN.

From a biological point of view, it seems reasonable to ascertain that a patient will obtain benefits thanks to the mechanical effects provided by the needle and that patients may benefit more if the electrolysis effect is added to the mechanical stimuli provided by the needle. Therefore, the aim of this randomized controlled study is to compare the effectiveness of DN versus PNE for the level of pain in patients suffering from PHP.

### Conditions Module

**Conditions:**

- Plantar Fascitis

- Myofacial Pain Syndromes

- Trigger Point Pain, Myofascial

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study is a prospective, two parallel-groups (participant) randomized controlled trial with blinded outcome assessment at baseline, and at 4, 8, 12, 26 and 52 weeks. The study flow chart shown in Figure 1 conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for nonpharmacological studies

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Participants who fulfill the inclusion criteria will receive the standardized oral and written information, and, once they consent to participate in the trial, will be randomized in a block system by blocks of 10 patients. Allocation to the groups will be achieved using a computer program (Randomizer, https://www.randomizer.org/) generated a random patient file numbers sequence by a third person not involved in the study from the file section in Kuwait. This person will be responsible for guarding the envelope with the information of the randomization. The envelopes will be closed until the moment of the intervention to maintain the blinding. This professional also will ask the patients for informed consent. The consent form is recruited upon the ethical medical committee at the ministry of health in the state of Kuwait.

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 102

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.

**Intervention Names:**

- Other: dry needling

**Label:** Dry needling (DN) arm

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.

**Intervention Names:**

- Other: dry needling

**Label:** Percutaneous needle electrolysis (PNE) arm

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dry needling (DN) arm

- Percutaneous needle electrolysis (PNE) arm

**Description:** The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.

**Name:** dry needling

**Other Names:**

- Percutaneous needle electrolysis

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain

**Measure:** Foot Health Status Questioner (FHSQ) PAIN

**Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks

#### Secondary Outcomes

**Description:** Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable

**Measure:** VAS Maximum

**Time Frame:** 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)

**Description:** The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.

**Measure:** The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)

**Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Clinical diagnosis of PHP in accordance with the Clinical Guidelines linked to the International Classification of Function, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association
* Age greater than 21 years according to the Kuwaiti law.
* History of plantar heel pain for greater than one month.
* Walking 50 meters without any support
* Having MTPs on initial physical examination on plantar and calf muscles
* Accepting to be treated by a male physiotherapist.
* Capacity to understand the study and the informed consent, as well as having signed the document.

Exclusion Criteria:

* - Needle phobia
* Allergy from needles or hypersensitivity to metals
* Presence of coagulopathy or use of anticoagulants
* Presence of peripheral arterial vascular disease
* Pregnancy
* Dermatological disease with the dry needling area
* The presence of a chronic medical condition that might preclude participation in the study such as malignancy, systemic inflammatory disorders (e.g. psoriatic arthritis, ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy, mononeuropathy.
* Treatment of plantar heel pain with needling or acupuncture during last 4 weeks.
* A history of injection therapy in the heel in the previous three months.
* Previous history of foot surgery or fracture.

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kuwait

**Country:** Kuwait

**Facility:** Physical Medicine and rehabilitation Kuwait

### IPD Sharing Statement Module

**Description:** ACCORDING TO THE LAW AND REGULATIONS FROM THE ETHICAL COMMITTEE IN KUWAIT. I CAN'T SHARE THE NAME OF THE PATIENTS, THEIR CONTACT OR ID. OTHER DATA WHICH ARE RELATED TO THE STUDY I CAN SHARE.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Fernandez D, Al-Boloushi Z, Bellosta-Lopez P, Herrero P, Gomez M, Calvo S. Cost-Effectiveness of Two Dry Needling Interventions for Plantar Heel Pain: A Secondary Analysis of an RCT. Int J Environ Res Public Health. 2021 Feb 12;18(4):1777. doi: 10.3390/ijerph18041777.

**PMID:** 33673068

**Citation:** Al-Boloushi Z, Gomez-Trullen EM, Arian M, Fernandez D, Herrero P, Bellosta-Lopez P. Comparing two dry needling interventions for plantar heel pain: a randomised controlled trial. BMJ Open. 2020 Aug 20;10(8):e038033. doi: 10.1136/bmjopen-2020-038033.

**PMID:** 32819949

**Citation:** Al-Boloushi Z, Gomez-Trullen EM, Bellosta-Lopez P, Lopez-Royo MP, Fernandez D, Herrero P. Comparing two dry needling interventions for plantar heel pain: a protocol for a randomized controlled trial. J Orthop Surg Res. 2019 Jan 25;14(1):31. doi: 10.1186/s13018-019-1066-4.

**PMID:** 30683124

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-01-23

- Filename: ICF_000.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 2505166

- Type Abbrev: ICF

- Upload Date: 2021-01-23T05:03

- Date: 2021-01-23

- Filename: Prot_SAP_001.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 217179

- Type Abbrev: Prot_SAP

- Upload Date: 2021-01-23T05:11

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000005534

- Term: Foot Diseases

- ID: D000009135

- Term: Muscular Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000005155

- Term: Facial Nerve Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000003389

- Term: Cranial Nerve Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M8351

- Name: Fasciitis

- Relevance: HIGH

- As Found: Fasciitis

- ID: M24656

- Name: Fasciitis, Plantar

- Relevance: HIGH

- As Found: Plantar Fasciitis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M8486

- Name: Fibromyalgia

- Relevance: LOW

- As Found: Unknown

- ID: M12161

- Name: Myofascial Pain Syndromes

- Relevance: HIGH

- As Found: Trigger Point Pain, Myofascial

- ID: M12381

- Name: Neuralgia

- Relevance: LOW

- As Found: Unknown

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

- ID: M8299

- Name: Facial Neuralgia

- Relevance: HIGH

- As Found: Myofacial Pain Syndromes

- ID: M8300

- Name: Facial Pain

- Relevance: HIGH

- As Found: Myofacial Pain

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8658

- Name: Foot Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M8298

- Name: Facial Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6605

- Name: Cranial Nerve Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005208

- Term: Fasciitis

- ID: D000036981

- Term: Fasciitis, Plantar

- ID: D000009209

- Term: Myofascial Pain Syndromes

- ID: D000005156

- Term: Facial Neuralgia

- ID: D000005157

- Term: Facial Pain

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Unable to tolerate pain of the treatment

#### Event Groups

**Group ID:** EG000

**Title:** Dry Needling

**Deaths Num At Risk:** 51

**Description:** Once the clinician located the MTrP, the needle was inserted over the same and a rapid needle entry was performed. The chosen technique for manipulating the needle was the technique described by Hong, which consists of a rapid needle entry and exit (fast in/fast out), in order to obtain a local twitch response, lasting 5 seconds employing a rhythmic movement at approximately 1Hz/sec (5 entries).

**ID:** EG000

**Other Num Affected:** 9

**Other Num at Risk:** 51

**Serious Number At Risk:** 51

**Title:** Dry Needling

**Group ID:** EG001

**Title:** Percutaneous Needle Electrolysis

**Deaths Num At Risk:** 51

**Description:** The electrotherapy equipment used (Physio Invasiva, PRIM Fisioterapia, Spain) produced a continuous galvanic current through the cathode while the patient held a hand-held anode.18 Once the needle reached the relevant treatment area, this was needled in exactly the same manner as in the dry needling group, with the only difference being that the needle was transmitting an electrical current with an intensity of 1.5 mA (intensity was adapted to patient´s characteristics according to their pain tolerance).

**ID:** EG001

**Other Num Affected:** 14

**Other Num at Risk:** 51

**Serious Number At Risk:** 51

**Title:** Percutaneous Needle Electrolysis

**Frequency Threshold:** 5

#### Other Events

**Term:** unable to tolerate pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Unable to tolerate pain of the treatment

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** drop out

**Time Frame:** 1 year follow up

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 51

**Group ID:** BG001

**Value:** 51

**Group ID:** BG002

**Value:** 102

**Units:** Participants

### Group

**ID:** BG000

**Title:** Dry Needling (DN) Arm

**Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.

### Group

**ID:** BG001

**Title:** Percutaneous Needle Electrolysis (PNE) Arm

**Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 51

#### Measurement

**Group ID:** BG001

**Value:** 51

#### Measurement

**Group ID:** BG002

**Value:** 102

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.9

**Value:** 49.5

#### Measurement

**Group ID:** BG001

**Spread:** 8.8

**Value:** 48.1

#### Measurement

**Group ID:** BG002

**Spread:** 8.8

**Value:** 48.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 36

#### Measurement

**Group ID:** BG002

**Value:** 72

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 51

#### Measurement

**Group ID:** BG001

**Value:** 51

#### Measurement

**Group ID:** BG002

**Value:** 102

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 51

#### Measurement

**Group ID:** BG001

**Value:** 51

#### Measurement

**Group ID:** BG002

**Value:** 102

**Class Title:** Kuwait

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** pherrero@usj.es
**Organization:** Head of iPhysio Research Group. Editor-in-Chief Journal of Invasive Techniques in Physical Therapy
**Phone:** (+34) 646168248
**Title:** Dr. Pablo Herrero Gallego. PT, PhD.
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18.8
- **Upper Limit:** 
- **Value:** 38.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 21.9
- **Upper Limit:** 
- **Value:** 40.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 27.7
- **Upper Limit:** 
- **Value:** 73.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 25.7
- **Upper Limit:** 
- **Value:** 71.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 28.4
- **Upper Limit:** 
- **Value:** 70.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26.8
- **Upper Limit:** 
- **Value:** 67.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 24.8
- **Upper Limit:** 
- **Value:** 66.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26.8
- **Upper Limit:** 
- **Value:** 63.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25.3
- **Upper Limit:** 
- **Value:** 68.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 27.1
- **Upper Limit:** 
- **Value:** 67.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25.1
- **Upper Limit:** 
- **Value:** 68.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 29.0
- **Upper Limit:** 
- **Value:** 73.1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.0
- **Upper Limit:** 
- **Value:** 7.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.3
- **Upper Limit:** 
- **Value:** 7.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.3
- **Upper Limit:** 
- **Value:** 6.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.9
- **Upper Limit:** 
- **Value:** 5.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.6
- **Upper Limit:** 
- **Value:** 5.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.1
- **Upper Limit:** 
- **Value:** 5.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.9
- **Upper Limit:** 
- **Value:** 4.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.0
- **Upper Limit:** 
- **Value:** 4.5
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.23
- **Upper Limit:** 
- **Value:** 0.63
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** 0.67
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** 0.78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.24
- **Upper Limit:** 
- **Value:** 0.76
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.23
- **Upper Limit:** 
- **Value:** 0.72
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.23
- **Upper Limit:** 
- **Value:** 0.74
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.30
- **Upper Limit:** 
- **Value:** 0.64
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.27
- **Upper Limit:** 
- **Value:** 0.70
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.29
- **Upper Limit:** 
- **Value:** 0.65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.27
- **Upper Limit:** 
- **Value:** 0.73
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.27
- **Upper Limit:** 
- **Value:** 0.66
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 0.77
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18.8
- **Upper Limit:** 
- **Value:** 38.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 21.9
- **Upper Limit:** 
- **Value:** 40.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 27.7
- **Upper Limit:** 
- **Value:** 73.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 25.7
- **Upper Limit:** 
- **Value:** 71.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 28.4
- **Upper Limit:** 
- **Value:** 70.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26.8
- **Upper Limit:** 
- **Value:** 67.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 24.8
- **Upper Limit:** 
- **Value:** 66.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26.8
- **Upper Limit:** 
- **Value:** 63.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25.3
- **Upper Limit:** 
- **Value:** 68.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 27.1
- **Upper Limit:** 
- **Value:** 67.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25.1
- **Upper Limit:** 
- **Value:** 68.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 29.0
- **Upper Limit:** 
- **Value:** 73.1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
**Title:** Foot Health Status Questioner (FHSQ) PAIN
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
**ID:** OG000
**Title:** Dry Needling (DN) Arm
##### Group
**Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
**ID:** OG001
**Title:** Percutaneous Needle Electrolysis (PNE) Arm
#### Outcome Measure 2
**Description:** Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)
**Title:** VAS Maximum
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain
**ID:** OG000
**Title:** VAS DN
##### Group
**Description:** the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain
**ID:** OG001
**Title:** VAS PNE
#### Outcome Measure 3
**Description:** The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"
**Title:** The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
**ID:** OG000
**Title:** Dry Needling (DN) Arm
##### Group
**Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
**ID:** OG001
**Title:** Percutaneous Needle Electrolysis (PNE) Arm
#### Outcome Measure 4
**Description:** Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
**Title:** Foot Health Status Questioner (FHSQ) PAIN
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
**ID:** OG000
**Title:** Dry Needling (DN) Arm
##### Group
**Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
**ID:** OG001
**Title:** Percutaneous Needle Electrolysis (PNE) Arm
### Participant Flow Module
#### Group
**Description:** Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
**ID:** FG000
**Title:** Dry Needling (DN) Arm
#### Group
**Description:** The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.

dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
**ID:** FG001
**Title:** Percutaneous Needle Electrolysis (PNE) Arm
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 13
###### Reason
**Group ID:** FG001
**Number of Subjects:** 21
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 51
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 51
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 38
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 30
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 21
**Has Results:** True