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Decompression Versus Heat and Decompression in Knee OA

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06428071
Enrollment
75
Registered
2024-05-24
Start date
2024-06-15
Completion date
2024-12-30
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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

Interventions

OTHERstandard 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

OTHERknee Decompression

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

OTHERhot 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

Sponsors

University of Hail
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

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.

Intervention model description

3 arm parallel randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain intensityat base lineVisual 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.
active knee range of motionat baselinethis 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.
functionat baselineIt 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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026