NCT05052593

Brief Summary

The purpose of the study is to compare the effects of compressive myofascial release and conventional knee osteoarthritis treatment to correct lateral patellar tracking. A randomized control trial was conducted at Railway General Hospital, Ahad Medicare clinics and physiotherapy Centre and The Health Professional physiotherapy clinic Bahria town phase 6. The sample size was 52 calculated through open-epi tool. The participants were divided into two interventional groups each having 26 participants. The study duration was six months. Sampling technique applied was non probability convenient sampling for recruitment and group randomization using sealed enveloped method. Only participants who were 50 years above with grade 2 and 3 knee osteoarthritis were included in the study. Tools used in this study are Q angle, numeric pain rating scale, goniometry and WOMAC questionnaire, Self structured Questionnaire. Data was collected at baseline, at the end of 3rd session and 6th session. Data analyzed through SPSS version 23.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

June 11, 2021

Last Update Submit

September 13, 2021

Conditions

Keywords

knee osteoarthritiscompressive myofascial releaselateral patellar tracking

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities Arthrosis Index (WOMAC) scale:

    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 Outcomes (1)

  • Numeric Pain Rating Scale:

    4th Week

Other Outcomes (3)

  • Functional Reach Test:

    4th Week

  • Measurement Quadriceps Angle:

    4th Week

  • Goniometry:

    4th Week

Study Arms (2)

Compressive myofascial release

EXPERIMENTAL

. 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)

Other: compressive myofascial release

Conventional treatment

ACTIVE COMPARATOR

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)

Other: conventional treatment group

Interventions

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.

Compressive myofascial release

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)

Conventional treatment

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • history of recent trauma to knee
  • History of hip disease
  • Past history of knee surgery/arthroplasty
  • Intraarticular corticosteroid injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bone and joints centre

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (24)

  • 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.

    PMID: 1953815BACKGROUND
  • Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

    PMID: 20699159BACKGROUND
  • Hunter DJ, Felson DT. Clinical review: osteoarthritis. British Medical Journal [periódico online]. 2006:639-42.

    BACKGROUND
  • 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.

    PMID: 1415887BACKGROUND
  • Ntagiopoulos PG, Dejour D. Patellofemoral Pain, Instability, and Arthritis. Patellofemoral Pain, Instability, and Arthritis: Clinical Presentation, Imaging, and Treatment. 2020:1.

    BACKGROUND
  • 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.

    PMID: 26379982BACKGROUND
  • 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.

    PMID: 31987560BACKGROUND
  • 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.

    PMID: 29373060BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26872913BACKGROUND
  • 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.

    PMID: 31567717BACKGROUND
  • Nguyen TV. Osteoarthritis in southeast Asia. International Journal of Clinical Rheumatology. 2014.

    BACKGROUND
  • 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.

    PMID: 17216685BACKGROUND
  • 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.

    PMID: 28750978BACKGROUND
  • 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.

    PMID: 23528815BACKGROUND
  • 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.

    PMID: 29731662BACKGROUND
  • 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.

    PMID: 30949343BACKGROUND
  • 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.

    PMID: 31858210BACKGROUND
  • 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.

    PMID: 20103404BACKGROUND
  • 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.

    PMID: 2229941BACKGROUND
  • 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.

    BACKGROUND
  • Manheim CJ. The Myofascial Release Manual: SLACK; 2008

    BACKGROUND
  • 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.

    PMID: 22828288BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Lal Gul Khan, MScPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: the purpose of this study is to compare the effects of compressive myofascial release on lateral patellar tracking inpatients with knee osteoarthritis. an RCT trial was conducted at Railway general hospital, Ahad medi care clinics and physiotherapy centre rawat and THP Bahria town phase 6.sample size was 52 calculated through open-epi tool. participants divided into control and experimental group.participants diagnosed with grade 2and 3 K\&L classification of knee OA included.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

September 22, 2021

Study Start

August 14, 2020

Primary Completion

July 30, 2021

Study Completion

July 31, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations