## Protocol Section
### Identification Module
**NCT ID:** NCT06428071

**Brief Title:** Decompression Versus Heat and Decompression in Knee OA

**Official Title:** Mechanical Knee Decompression With and Without Heating: Impact on Pain, Function, and Range of Motion

#### Organization Study ID Info
**ID:** H-2024-265
#### Organization
**Class:** OTHER
**Full Name:** University of Hail
### Status Module
#### Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Hail

#### Responsible Party

**Investigator Affiliation:** University of Hail

**Investigator Full Name:** Hisham Mohamed Hussein

**Investigator Title:** principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** a randomized controlled trial tends to compare the effects of adding superficial heating during the application of knee decompression session to the results of decompression alone without heating.

**Detailed Description:** Osteoarthritis (OA) is a progressive multifactorial joint disease characterized by chronic pain and functional disability due to the degeneration of the articular cartilage. The knee joint is the most vulnerable joint in the human body and occupies four-fifths of the burden of OA worldwide. Subjects having KOA demonstrate deferent clinical and radiological characteristics such as narrowed joint space, osteophytes around the articular surface, subchondral sclerosis, pain, limited range of motion (ROM), and declined functional status.

Except for the arthroplasty for the severely arthritic knee joint, there is no cure for the degeneration of joint cartilage. Medications, exercises, and physical agents can be used to address the associated pain, muscular tightness, weakness, and physical disability.

Interestingly, previous efforts that applied traction (decompression) on the arthritic knee joint demonstrated favorable results even on the thickness of the articular cartilage. However, these methods were mainly invasive surgical procedures that encountered disadvantages like the risk of infection and prolonged bedridden that might affect the general health of the patients

### Conditions Module

**Conditions:**

- Knee Osteoarthritis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 3 arm parallel randomized controlled trial

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** This study will be double-blinded consequently neither the assessor nor the data analyzer will be aware of the allocation sequence. Each participant will be coded using special numbers that refer to the correct allocation. The interpretation of these code numbers will be kept with the senior author who will not be involved in the treatment or assessment. The therapist will only be allowed to get the code number interpretation after the end of the allocation process and at the beginning of the study. In this study, the participants and the therapist will be blind.

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All Patients in the three groups will receive supervised systematic exercise therapy that was performed effectively in previous work. This program consisted of lower limb static, dynamic, and flexibility exer¬cises that targeted the quadriceps, hamstrings, and gluteus muscles; and core strength training for 20 minutes per day. This program will be applied 3 times per week for 6 weeks

**Intervention Names:**

- Other: standard physical therapy

**Label:** Standard physical therapy program

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The ACUTRAC AT270 Traction System device will be used for traction. The patient will assume the supine position with the hip of the treated limb in semi-flexion and the ipsilateral knee in 25-30º flexion. 15 minutes of continuous mechanical traction using 20% of the patient's weight will be used. The session will be 15 minutes, once a day, three-times a week for 6 weeks.

This group will receive decompression and standard physical therapy.

**Intervention Names:**

- Other: standard physical therapy

- Other: knee Decompression

**Label:** knee Decompression

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** this group will receive the standard physical therapy, the mechanical decompression and superficial heating using heat pad on the knee joint for 20 minutes while the patient receives the decompression session

**Intervention Names:**

- Other: standard physical therapy

- Other: knee Decompression

- Other: hot pack

**Label:** Decompression plus heating

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Decompression plus heating

- Standard physical therapy program

- knee Decompression

**Description:** All Patients in the three groups will receive supervised systematic exercise therapy that was performed effectively in previous work. This program consisted of lower limb static, dynamic, and flexibility exer¬cises that targeted the quadriceps, hamstrings, and gluteus muscles; and core strength training for 20 minutes per day. This program will be applied 3 times per week for 6 weeks to all the participants

**Name:** standard physical therapy

**Other Names:**

- routine physical therapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Decompression plus heating

- knee Decompression

**Description:** continuous mechanical decompression using 20% of the body weight as a traction force for 15 minutes.

**Name:** knee Decompression

**Other Names:**

- knee traction

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Decompression plus heating

**Description:** hot pack over the treated knee joint will be applied for 20 minutes. this application will be performed while the patient is receiving the decompression session

**Name:** hot pack

**Other Names:**

- superficial heating

- moist heat

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Visual Analog Scale (VAS) will be used to assess pain. This scale is proved to be valid and reliable mean of assessing pain. The patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The outcomes range between no pain to sever pain according to the distance in mm measured from the 0 point of the horizontal line.

**Measure:** pain intensity

**Time Frame:** at base line

**Description:** Visual Analog Scale (VAS) will be used to assess pain. This scale is proved to be valid and reliable mean of assessing pain. The patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The outcomes range between no pain to sever pain according to the distance in mm measured from the 0 point of the horizontal line.

**Measure:** pain intensity

**Time Frame:** after the end of the treatment (after 6 weeks)

**Description:** this outcome will be assessed using a vlaid and reliable android-mobile application designed to assess joint range of motion (ROM). The mobile phone will be secured to the lateral aspect of the leg so that the normal extension will be represented as zero on the app screen. The patient will be asked to move the tested knee from the maximum extension to the maximum available flexion. The value of the angle will be recorded. The difference between the extension angle and flexion angle will be calculated.

**Measure:** active knee range of motion

**Time Frame:** at baseline

**Description:** this outcome will be assessed using a vlaid and reliable android-mobile application designed to assess joint range of motion (ROM). The mobile phone will be secured to the lateral aspect of the leg so that the normal extension will be represented as zero on the app screen. The patient will be asked to move the tested knee from the maximum extension to the maximum available flexion. The value of the angle will be recorded. The difference between the extension angle and flexion angle will be calculated.

**Measure:** active knee range of motion

**Time Frame:** after the end of the treatment (after 6 weeks)

**Description:** It is consisted of 24 questions, five related to pain, two related to stiffness and 17 to physical function. Its reliability was proved in previous work.the questions in this scale takes from 0 to 4 points and the total will be calculated. higher scores indicate more disability

**Measure:** function

**Time Frame:** at baseline

**Description:** It is consisted of 24 questions, five related to pain, two related to stiffness and 17 to physical function. Its reliability was proved in previous work.the questions in this scale takes from 0 to 4 points and the total will be calculated. higher scores indicate more disability

**Measure:** function

**Time Frame:** after the end of the treatment (after 6 weeks)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Both sexes
* age between 45 to 60 years.
* Normal and or overweight categories of BMI 19-30 kg/m2
* Unilateral (grade 2 and 3) knee OA according to the Kellgren-Lawrence radiological rating scale

Exclusion Criteria:

* lower limb deformities as genu varum, valgus, flat foot
* leg length discrepancy
* previous trauma and or surgery to the knee joint
* Bone disease
* Inability to refrain from analgesic/anti-inflammatory medications for 6 weeks

**Maximum Age:** 60 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hail

**Contacts:**

***Contact 1:***

- **Email:** hm.hussein@uoh.edu.sa

- **Name:** Hisham Hussein

- **Role:** CONTACT

**Country:** Saudi Arabia

**Facility:** Hisham Hussein

**Zip:** 3994

### IPD Sharing Statement Module

**Description:** the data will be available with the senior author up on request

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Knee Osteoarthritis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Misc Info Module

- Version Holder: 2024-05-31
