Decompression Versus Heat and Decompression in Knee OA

NCT ID: NCT06428071

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2024-12-30

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

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard physical therapy program

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

Group Type: ACTIVE_COMPARATOR

standard physical therapy

Intervention Type: 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

knee Decompression

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.

Group Type: EXPERIMENTAL

standard physical therapy

Intervention Type: 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

knee Decompression

Intervention Type: OTHER

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

Decompression plus heating

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

Group Type: EXPERIMENTAL

standard physical therapy

Intervention Type: 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

knee Decompression

Intervention Type: OTHER

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

hot pack

Intervention Type: 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

Interventions

standard physical therapy

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

Intervention Type: OTHER

knee Decompression

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

Intervention Type: OTHER

hot pack

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

Intervention Type: OTHER

Other Intervention Names

routine physical therapy; knee traction; superficial heating; moist heat

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hail

OTHER

Sponsor Role: lead

Responsible Party

Hisham Mohamed Hussein

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hisham Hussein

Hail, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

H-2024-265

Identifier Type: -

Identifier Source: org_study_id