## Protocol Section
### Identification Module
**NCT ID:** NCT05623579

**Brief Title:** Education on BDNF on Pain Levels

**Official Title:** Effect of Therapeutic Education on Pain Intensity and BDNF Levels in Patients With Chronic Pain

#### Organization Study ID Info
**ID:** 2022A36005
#### Organization
**Class:** OTHER
**Full Name:** Universidad Autonoma de Madrid
### Status Module
#### Completion Date
**Date:** 2025-05-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-30

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-01

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2022-11-21
**Type:** ACTUAL
**Study First Submit Date:** 2022-10-25
**Study First Submit QC Date:** 2022-11-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Universidad Rey Juan Carlos

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidad Autonoma de Madrid

#### Responsible Party

**Investigator Affiliation:** Universidad Autonoma de Madrid

**Investigator Full Name:** Raúl Ferrer-Peña

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The promotion of neuroplasticity in conjunction with strategies for restructuring maladaptive cognitions that largely cause the activation of neural networks that contribute to the perpetuation of pain is therefore a fundamental neurophysiological principle for establishing a neurophysiological basis for pain.

perpetuation of pain, is therefore a fundamental neurophysiological principle for establishing physiotherapy therapeutic to establish therapeutic strategies from physiotherapy that contribute to improve the quality of life of patients with chronic pain. patients with chronic pain.

Based on the theory that neurotrophic factors such as BDNF play a fundamental role in the initiation and or maintenance of hyperexcitability of central neurons in pain, we consider that the levels of this neurotrophic factor, such as BDNF, may have an important role in the perpetuation of pain.

that the levels of this neurotrophic factor may be modified by the application of a therapeutic education protocol, favoring therapeutic education protocol, favoring a reduction in pain intensity.

### Conditions Module

**Conditions:**

- Chronic Pain

- Musculoskeletal Pain

**Keywords:**

- BDNF

- Pain Neuroscience Education

- Exercise

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 66

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pain Education plus Exercise

**Intervention Names:**

- Behavioral: Pain Neuroscience Education

- Behavioral: Exercise

**Label:** Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Exercise

**Intervention Names:**

- Behavioral: Exercise

**Label:** Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** 8 Sessions of different pain education interventions

**Name:** Pain Neuroscience Education

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control

- Intervention

**Description:** 12 Sessions of Aerobic Exercise

**Name:** Exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Pain intensity assessed with the 100 mm Visual Analog Scale, in which the patient is asked about his or her pain level at that moment, with one side being "no pain" and the other extreme being "the worst pain imaginable".

**Measure:** Pain Intensity

**Time Frame:** 36 weeks

#### Secondary Outcomes

**Description:** BDNF level measured in blood serum by ELISA kit at baseline and at the end of the intervention.

**Measure:** BDNF level

**Time Frame:** 36 weeks

**Description:** Anxiety and depression will be assessed using the Spanish validated version of the HADS. The HADS is a self-administered measure with 14 items in total that ask the client to reflect on their mood in the past week. Seven items assess depression, 5 of which are markers for anhedonia (an inability to experience pleasure), and 2 concern appearance and feelings of slowing down. Seven items assess anxiety, of which 2 assess autonomic anxiety (panic and butterflies in the stomach), and the remaining 5 assess tension and restlessness (Dunbar, Ford, Hunt, \& Der, 2000).

**Measure:** Anxiety and Depression (HADS)

**Time Frame:** 36 weeks

**Description:** The EQ-5D is a generic HRQoL. HRQoL that can be used both in relatively healthy individuals (general population) and in groups of patients with different pathologies. The individual assesses his or her own health status, first in levels of severity by dimensions and then on a more general visual analog scale (VAS).The third element of the EQ-5D is the index of social values that is obtained for each health state generated by the instrument. In this part of the questionnaire, the individual must mark the level of severity corresponding to his or her health status in each of the dimensions health status in each of the dimensions, referring to the same day on which the same day the questionnaire is completed.

**Measure:** Quality of life (EQ-5D)

**Time Frame:** 36 weeks

**Description:** Pain Catastrophism will be measured with the Spanish version of the Pain Catastrophism Scale. The Pain Catastrophizing Scale (PCS) is a 13-item self-report questionnaire considered to be the most frequent and extensively studied tool to assess pain catastrophizing for chronic pain. Good levels of content and construct validity, internal consistency and test-retest reliability of the PCS have been reported in studies examining different musculoskeletal disorders and different language versions.

**Measure:** Pain Catastrophism (PCS)

**Time Frame:** 36 weeks

**Description:** Pain severity will be measured Chronic Pain Grading Scale Description: A measure of pain intensity and interference with normal daily activities.

Format: 7 items

Scoring: Scores for 6 of the items range from 0 (no pain) to 10 (pain as bad as it could be). The one remaining item requires filling in the number of days that pain has kept respondents from their typical activities.

Scores classify respondents into one of 4 levels of pain intensity and activity interference:

Low disability and low pain intensity Low disability and high pain intensity High disability and moderate limitation of activities High disability and severe limitation of activities

**Measure:** Pain Severity Level (GCPS-R)

**Time Frame:** 36 weeks

**Description:** measured with a finger pulse oximeter: A normal ABG oxygen level for healthy lungs falls between 80 and 100 millimeters of mercury (mm Hg).

**Measure:** Oxygen Saturation (SpO2)

**Time Frame:** 36 weeks

**Description:** measured with a finger pulse oximeter: A normal Heart Rate is between 60 and 120 pulse per minute.

**Measure:** Heart rate (HR)

**Time Frame:** 36 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* males and females aged 18 to 65 years with musculoskeletal pain for a minimum of 3 months
* patients recruited by information pamphlets from the university clinic of the Rey Juan Carlos University, and CSEU La Salle
* not having received physiotherapy treatment for this same process in the last 3 months.
* ability to perform all the clinical tests and to understand the study process, as well as to obtain informed consent.

Exclusion Criteria:

- Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Alcorcón

**Contacts:**

***Contact 1:***

- **Email:** josue.fernadez@urjc.es

- **Name:** Josue Fernández-Carnero

- **Role:** CONTACT

**Country:** Spain

**Facility:** Clínica URJC

**State:** Madrid

**Status:** NOT_YET_RECRUITING

**Zip:** 28922

**Location 2:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Email:** luis.matesanz@lasallecanpus.es

- **Name:** Luis Matesanz

- **Phone:** +34607712148

- **Role:** CONTACT

***Contact 2:***

- **Name:** Silvia Di Bonaventura

- **Role:** SUB_INVESTIGATOR

**Country:** Spain

**Facility:** IRF La Salle

**Status:** RECRUITING

**Zip:** 28023

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Mills SEE, Nicolson KP, Smith BH. Chronic pain: a review of its epidemiology and associated factors in population-based studies. Br J Anaesth. 2019 Aug;123(2):e273-e283. doi: 10.1016/j.bja.2019.03.023. Epub 2019 May 10.

**PMID:** 31079836

**Citation:** Andias R, Neto M, Silva AG. The effects of pain neuroscience education and exercise on pain, muscle endurance, catastrophizing and anxiety in adolescents with chronic idiopathic neck pain: a school-based pilot, randomized and controlled study. Physiother Theory Pract. 2018 Sep;34(9):682-691. doi: 10.1080/09593985.2018.1423590. Epub 2018 Jan 10.

**PMID:** 29319386

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal 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: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M29444

- Name: Musculoskeletal Pain

- Relevance: HIGH

- As Found: Musculoskeletal Pain

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059352

- Term: Musculoskeletal Pain

- ID: D000059350

- Term: Chronic Pain

### Misc Info Module

- Version Holder: 2024-05-24
