Decompression Versus Heat and Decompression in Knee OA

NCT06428071 | Completed

• 1 other identifier: H-2024-265
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• pain intensity

  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.

  at base line

• pain intensity

  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.

  after the end of the treatment (after 6 weeks)

• active knee range of motion

  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.

  at baseline

• active knee range of motion

  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.

  after the end of the treatment (after 6 weeks)

• function

  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

  at baseline

• function

  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

  after the end of the treatment (after 6 weeks)

Study Arms (3)

Standard physical therapy program

ACTIVE COMPARATOR

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

Other: standard physical therapy

knee Decompression

EXPERIMENTAL

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.

Other: standard physical therapy; Other: knee Decompression

Decompression plus heating

EXPERIMENTAL

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

Other: standard physical therapy; Other: knee Decompression; Other: hot pack

Interventions

standard physical therapy OTHER

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

Also known as: routine physical therapy

Decompression plus heating; Standard physical therapy program; knee Decompression

knee Decompression OTHER

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

Also known as: knee traction

Decompression plus heating; knee Decompression

hot pack OTHER

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

Also known as: superficial heating, moist heat

Decompression plus heating

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

Hisham Hussein

Hail, 3994, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 3 arm parallel randomized controlled trial

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: June 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)