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Completed

NCT Number: NCT06428071

Decompression Versus Heat and Decompression in Knee OA

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hisham Hussein

Ha'il, 3994, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: routine physical therapy

knee Decompression

Other

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

Other names: knee traction

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

Other names: superficial heating, moist heat

Primary outcomes

  1. pain intensity

    Time frame: at base line

    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.

  2. pain intensity

    Time frame: after the end of the treatment (after 6 weeks)

    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.

  3. active knee range of motion

    Time frame: at baseline

    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.

  4. active knee range of motion

    Time frame: after the end of the treatment (after 6 weeks)

    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.

  5. function

    Time frame: at baseline

    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

  6. function

    Time frame: after the end of the treatment (after 6 weeks)

    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

Sponsors and collaborators

Lead sponsor

University of Hail

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 24, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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