- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05052593
Compressive Myofascial Release in Knee Osteoarthritis
Effects of Compressive Myofascial Release of Vastus Lateralis on Lateral Patellar Tracking in Patients With Knee Osteoarthritis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan
- Railway General Hospital
-
Rawalpindi, Punjab, Pakistan, 46000
- Bone and joints centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Includes diagnosed cases of knee osteoarthritis
- Grades 2-3 according to the Kellgren and Lawrence method of grading(1)
- Includes patients from the age group of 50 years and above(3)
- Includes knee osteoarthritis patients with lateral tracking of patella which will assessed through Q angle test(4)
Exclusion Criteria:
- history of recent trauma to knee
- History of hip disease
- Past history of knee surgery/arthroplasty
- Intraarticular corticosteroid injection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Compressive myofascial release
. patients in this group will receive treatment through CMR that includes shaking the muscle belly of vastus lateralis for 30 seconds. Then the hip is fully extended on treatment table and CMR is applied on Vastus lateralis muscle for 1 minute. Treatment consists of broad strokes applied with clinicians knuckles to release superficial restrictions, followed by more specific strokes applied with clinicians' thumb on tight muscle. Strokes are applied at a contact point of 45 degree. with pressure directed from distal to proximal. Conventional treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold) |
Patients in this group will receive treatment through CMR that includes shaking the muscle belly of vastus lateralis for 30 seconds.
Then the hip is fully extended on treatment table and CMR is applied on Vastus lateralis muscle for 1 minute.
Treatment consists of broad strokes applied with clinicians knuckles to release superficial restrictions, followed by more specific strokes applied with clinicians' thumb on tight muscle.
Strokes are applied at a contact point of 45 degree.
With pressure directed from distal to proximal.
|
Active Comparator: Conventional treatment
Patients in this group will receive treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold)
|
Patients in this group will receive treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Western Ontario and McMaster Universities Arthrosis Index (WOMAC) scale:
Time Frame: 4th Week
|
Western Ontario and McMaster Universities Arthrosis Index WOMAC was first developed in 1988 by Bellamy for use in patients with hip and knee osteoarthritis is a self-administered tool comprising of 24 items divided into 3 sub scales.
It was used to assess pain, stiffness and physical function in knee osteoarthritis patients which were allocated in the study.
Patient's pain is assessed by asking about intensity of pain in different positions including pain intensity at rest through 5 questions.
Patient is asked about stiffness level in the morning and evening (2 questions).
Patients is also assessed for difficulty doing several daily and self-care activities in 17 different questions.
Each item in sub scale carries maximum score of 4 and minimum score of 0. Overall score of WOMAC scale is 100 with a cutoff value of 39.
In first session, 2 and 4 weeks after treatment sessions.
|
4th Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale:
Time Frame: 4th Week
|
Numeric pain rating scale is a type of scale which is used to measure pain intensity.
It is easy to use as the patient can report the intensity of his/her pain by simply looking at the scale.
The scale has ratings from 0 to 10, where the point 0 means no pain, the points 1, 2 and 3 measure pain of mild intensity, the points 4,5 and 6 measure pain of moderate intensity and the demarcations 7,8,9 and 10 measures severe intensity of pain.
It was used in this study to measure the intensity of knee joint pain reported by each patient.
Numeric pain rating scale is preferred over visual analog scale for use in elderly individuals.
The patients are asked about the subjective examination of intensity of pain after describing the demarcations present on the scale to the patient about the maximum and minimum values.
In first session, 2 and 4 weeks after treatment sessions.
|
4th Week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Reach Test:
Time Frame: 4th Week
|
Functional reach test was utilized to determine instability present in the patient, in particular, dynamic standing balance was measured.
During this test the participant was advised to stand next to the wall, not leaning against the wall, feet were at a comfortable distance apart.
Care must be taken to assess the patient who is elderly and the one who has balance issues.
Continuous supervision throughout the test is necessary and therapist must be there to help patient achieve and maintain the position.
The participant was asked to flex the dominant arm to 90 degree and reach as much forward as possible without overbalancing.
In first session, 2 and 4 weeks after treatment sessions.
|
4th Week
|
Measurement Quadriceps Angle:
Time Frame: 4th Week
|
Q-angle measurement was used to assess lateral patellar tilting that is the primary objective.
Q angle measurement with a goniometer is a standardized protocol and test-retest reliability was found out through intra-tester reliability study which included 52 adults with no history of knee injury.
Reliability came out to be to be 0.88(45).
Q-angle at knee is assessed by asking the patient to assume supine position with hip and knee extended at treatment table, arms by the side of the body, foot is always in neutral position with isometric contraction of rectus femoris.
The bony landmarks that are used to assess Q-angle are anterior superior iliac spine, tibial tuberosity, and patella.
In first session, 2 and 4 weeks after treatment sessions.
|
4th Week
|
Goniometry:
Time Frame: 4th Week
|
It was used to assess knee joint range of motion with a reliable and valid tool goniometer. It has a fulcrum and 2 arm that are used to measure the angle. Reliability is found out to be 0.92-0.99 which is categorized as good reliability. In this study goniometer was used to find out Q-angle, knee flexion ROM and knee extension ROM for each patient in both control and experimental groups. For Q-angle measurement the center point was placed at center of patella, the proximal arm was placed parallel to anterior superior iliac spine and distal arm was placed at tibial tuberosity of the patient. In first session, 2 and 4 weeks after treatment sessions. |
4th Week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Erratum In: Clin Geriatr Med. 2013 May;29(2):ix.
- Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
- Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.
- Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018.
- Stanek J, Sullivan T, Davis S. Comparison of Compressive Myofascial Release and the Graston Technique for Improving Ankle-Dorsiflexion Range of Motion. J Athl Train. 2018 Feb;53(2):160-167. doi: 10.4085/1062-6050-386-16. Epub 2018 Jan 26.
- Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.
- Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 Mar 18;332(7542):639-42. doi: 10.1136/bmj.332.7542.639. No abstract available.
- Brandt KD, Fife RS, Braunstein EM, Katz B. Radiographic grading of the severity of knee osteoarthritis: relation of the Kellgren and Lawrence grade to a grade based on joint space narrowing, and correlation with arthroscopic evidence of articular cartilage degeneration. Arthritis Rheum. 1991 Nov;34(11):1381-6. doi: 10.1002/art.1780341106.
- Doucette SA, Goble EM. The effect of exercise on patellar tracking in lateral patellar compression syndrome. Am J Sports Med. 1992 Jul-Aug;20(4):434-40. doi: 10.1177/036354659202000412.
- Ntagiopoulos PG, Dejour D. Patellofemoral Pain, Instability, and Arthritis. Patellofemoral Pain, Instability, and Arthritis: Clinical Presentation, Imaging, and Treatment. 2020:1.
- Turkmen F, Acar MA, Kacira BK, Korucu IH, Erkocak OF, Yolcu B, Toker S. A new diagnostic parameter for patellofemoral pain. Int J Clin Exp Med. 2015 Jul 15;8(7):11563-6. eCollection 2015.
- Rozenfeld E, Finestone AS, Moran U, Damri E, Kalichman L. The prevalence of myofascial trigger points in hip and thigh areas in anterior knee pain patients. J Bodyw Mov Ther. 2020 Jan;24(1):31-38. doi: 10.1016/j.jbmt.2019.05.010. Epub 2019 May 14.
- Vijayakumar M, Jaideep A, Khankal R. Effectiveness of Compressive Myofascial Release Vs Instrument Assisted Soft Tissue Mobilization in Subjects with Active Trigger Points of the Calf Muscle Limiting Ankle Dorsiflexion. International Journal of Health Sciences and Research. 2019;9(4):98-106
- De Souza IG, Pavan Kumar G. Effect of Releasing Myofascial Chain in Patients with Patellofemoral Pain Syndrome-A Randomized Clinical Trial. Int J Cur Res Rev| Vol. 2020;12(08):5.
- Ferre IM, Roof MA, Anoushiravani AA, Wasterlain AS, Lajam CM. Understanding the Observed Sex Discrepancy in the Prevalence of Osteoarthritis. JBJS Rev. 2019 Sep;7(9):e8. doi: 10.2106/JBJS.RVW.18.00182. No abstract available.
- Nguyen TV. Osteoarthritis in southeast Asia. International Journal of Clinical Rheumatology. 2014.
- Dor A, Kalichman L. A myofascial component of pain in knee osteoarthritis. J Bodyw Mov Ther. 2017 Jul;21(3):642-647. doi: 10.1016/j.jbmt.2017.03.025. Epub 2017 Apr 6.
- Weiss L, DeForest B, Hammond K, Schilling B, Ferreira L. Reliability of goniometry-based Q-angle. PM R. 2013 Sep;5(9):763-8. doi: 10.1016/j.pmrj.2013.03.023. Epub 2013 Mar 22.
- Shamsi M, Mirzaei M, Khabiri SS. Universal goniometer and electro-goniometer intra-examiner reliability in measuring the knee range of motion during active knee extension test in patients with chronic low back pain with short hamstring muscle. BMC Sports Sci Med Rehabil. 2019 Mar 22;11:4. doi: 10.1186/s13102-019-0116-x. eCollection 2019.
- Lage PTS, Machado LAC, Barreto SM, de Figueiredo RC, Telles RW. Measurement properties of Portuguese-Brazil Western Ontario and McMaster Universities osteoarthritis index (WOMAC) for the assessment of knee complaints in Brazilian adults: ELSA-Brasil Musculoskeletal cohort. Rheumatol Int. 2020 Feb;40(2):233-242. doi: 10.1007/s00296-019-04496-1. Epub 2019 Dec 19.
- Williams SB, Brand CA, Hill KD, Hunt SB, Moran H. Feasibility and outcomes of a home-based exercise program on improving balance and gait stability in women with lower-limb osteoarthritis or rheumatoid arthritis: a pilot study. Arch Phys Med Rehabil. 2010 Jan;91(1):106-14. doi: 10.1016/j.apmr.2009.08.150.
- Hill KD, Bernhardt J, McGann AM, Maltese D, Berkovits D. A new test of dynamic standing balance for stroke patients: reliability, validity and comparison with healthy elderly. Physiotherapy Canada. 1996;48(4):257-62.
- Manheim CJ. The Myofascial Release Manual: SLACK; 2008
- Bennell KL, Ahamed Y, Bryant C, Jull G, Hunt MA, Kenardy J, Forbes A, Harris A, Nicholas M, Metcalf B, Egerton T, Keefe FJ. A physiotherapist-delivered integrated exercise and pain coping skills training intervention for individuals with knee osteoarthritis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2012 Jul 24;13:129. doi: 10.1186/1471-2474-13-129.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- REC/00870 Rubia Batool
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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