- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07286669
Positional Release Technique of Iliotibial Band and Pes Anserine Versus Proprioception Exercise on Patients With Knee Osteoarthritis (PRT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nabil Abdel-Aal, phd
- Phone Number: 01200133613
- Email: nabil.mahmoud@cu.edu.eg
Study Contact Backup
- Name: Dina Magdy, master
- Phone Number: 01128016646
- Email: dinamagdy365@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both genders with knee osteoarthritis will participate in this study according to the American College of Rheumatology criteria
- An average pain intensity of ≥3 on a 10-cm visual analogue scale (VAS).
- Patients with unilateral knee osteoarthritis, for those patients with bilateral knee -Patients with grade II &lll chronic knee osteoarthritis (clinical and imaging diagnosis X-ray.
- Patients were referred by orthopedic physician.
- Patients with body mass index <30Kg/cm2.
Exclusion Criteria:
- Previous knee surgery
- Serious valgus or varus deformity
- Past or present vascular disorder.
- Acute or chronic low back pain.
- Upper motor neuron lesion and lower motor neuron lesion.
- A history of rheumatoid arthritis.
- Presence of malignancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Positional Release Technique
Twenty patients will receive positional release technique in addition to traditional exercises.
The treatment protocol will be 3 sessions per week for six weeks
|
Positional release of Pes Anserine:Slide the fingers approximately 1 inch (2.5 cm) medially from the tibial tuberosity onto the bony insertion site. On the well-developed patient, the mass of the tendons can be grasped as a group at the medial knee.Apply tibial traction or upward compression with the far hand for fine-tuning. Maintain for 90 seconds with repeation 3 times in a session with a break of 30 seconds. Positional release of iliotibial band:Stand on the side of the supine patient that is opposite the band to be palpated. With your hands flat, align them over the lateral thigh just below the greater trochanter of the femur. Apply cephalad compression of the limb with the far hand or your body to fine-tune. Maintain for 90 seconds with repetition 3 times in a session with a break of 30 seconds Stretch exercises: Rectus femoris, Iliotibial band, Hamstring and stretch for calf muscle (3sets, each stretch 30 sec hold, 30 second relaxation between each set 5sec rests). and repeated 3 times. Strengthen exercises: Isometric Exercises for quadriceps (10 rep,3sets), Hip abductors strengthening 45 degree (10 rep,3sets), Hip extensor strengthening 15 degree (10 rep,3sets), Straight leg raising 45-70 degree (10 rep,3sets), Short arc knee extension (10 rep,3sets) |
|
Experimental: proprioception exercises
Twenty patients will receive proprioception exercises in addition to traditional exercise.
The treatment protocol will be 3 sessions per week for six weeks.
|
Stretch exercises: Rectus femoris, Iliotibial band, Hamstring and stretch for calf muscle (3sets, each stretch 30 sec hold, 30 second relaxation between each set 5sec rests). and repeated 3 times. Strengthen exercises: Isometric Exercises for quadriceps (10 rep,3sets), Hip abductors strengthening 45 degree (10 rep,3sets), Hip extensor strengthening 15 degree (10 rep,3sets), Straight leg raising 45-70 degree (10 rep,3sets), Short arc knee extension (10 rep,3sets)
the patients will receive proprioceptive exercises in the form of Heel Walk, Toe Walk, Sideways Knitting Walk, Sideways Step,Cross Walk, Semi Tandem Walk, Tandem Walk, High Knee Walk, Wedding Walk, Backward Wedding Walk, balance and coordination exercises.
|
|
Active Comparator: traditional exercise
Twenty patients receive only traditional exercise.
Treatment protocol will be 3 session per week for six weeks
|
Stretch exercises: Rectus femoris, Iliotibial band, Hamstring and stretch for calf muscle (3sets, each stretch 30 sec hold, 30 second relaxation between each set 5sec rests). and repeated 3 times. Strengthen exercises: Isometric Exercises for quadriceps (10 rep,3sets), Hip abductors strengthening 45 degree (10 rep,3sets), Hip extensor strengthening 15 degree (10 rep,3sets), Straight leg raising 45-70 degree (10 rep,3sets), Short arc knee extension (10 rep,3sets) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
knee disabiity
Time Frame: up to 6 weeks
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was widely used in the evaluation of Hip and Knee Osteoarthritis.
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales;Pain (5 items),Stiffness (2 items), Physical Function (17 items): The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
|
up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: up to 6 weeks
|
Patients recorded pain intensity on a 100 mm VAS by drawing a vertical line on the horizontally positioned VAS.
The left end of the VAS represented 'no pain' and the right end 'most severe pain imaginable' with no intermediate divisions or descriptive terms
|
up to 6 weeks
|
|
range of motion
Time Frame: up to six weeks
|
The most often used clinical instrument for assessing joint AROM is the digital goniometer.
It is used as a valid and reliable AROM measurement device with a high validity, intra- rater and inter-rater reliability
|
up to six weeks
|
|
pressure pain threshold
Time Frame: up to six weeks
|
The pressure algometer will be used to measure pressure pain threshold
|
up to six weeks
|
|
knee joint position error
Time Frame: up to six weeks
|
Free inclinometer application (Goniometer Pro, 5fuf5, USA) for iPhone 6 (Apple, Cupertino, USA) at 30°, 45° and 75° target angles.
Active knee joint position sense will be assessing by iPhone inclinometer application.
All tests will be performed at sitting position without any contact of the feet to the floor, at a quiet place and with closed eyes
|
up to six weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006112
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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