Decompression Versus Heat and Decompression in Knee OA

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06428071
• Other study ID #: H-2024-265
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: University of Hail
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 30, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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
• knee Decompression
continuous mechanical decompression using 20% of the body weight as a traction force for 15 minutes.
• 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

Locations

Country	Name	City	State
Saudi Arabia	Hisham Hussein	Hail

Sponsors (1)

Lead Sponsor	Collaborator
University of Hail

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)