NCT04769531

Brief Summary

Knee osteoarthritis has been ranked 11th highest contributor to non-fatal burdens in the world. Many research studies have discussed the relationship of hip muscle with knee joint stating that impaired hip strength can be a reason for knee pain. Furthermore, mobilization has been shown to be helpful in reducing pain, increasing range of motion and physical function in Osteoarthritis. Despite the evidence, there are very few studies that actually conducted clinical trials to test the effectiveness of mobilizations and strengthening of hip muscles in knee Osteoarthritis. Therefore our aim is to evaluate the effectiveness of hip joint mobilizations and strength training in knee osteoarthritis. OBJECTIVE: To determine the effects of hip joint mobilizations and strengthening exercises, on pain, physical function and dynamic balance in patients with knee osteoarthritis (OA) using Visual analog scale, Knee injury and Osteoarthritis Outcome Score and four square step test. METHODOLOGY: A randomized control trial will be conducted on 66 subjects with knee osteoarthritis and age 50 years will be enrolled in this study after screening by referring consultants. This study will be carried out at Physiotherapy OPD of DUHS, Civil hospital Karachi and Rabia Moon Memorial Institute of Neurosciences Trust. Subjects will be assessed at baseline and after 18 sessions using Visual analog scale, Knee injury and Osteoarthritis Outcome Score and square step test for pain, physical functioning and dynamic balance respectively. The subjects will be allocated into three groups through simple random sampling. Group A (joint mobilization group) will receive hip mobilization techniques, hip strengthening exercises along with the best available knee exercises while group B (hip muscles strengthening group) will receive hip-strengthening exercises with the best available knee exercises. Group C (knee strengthening group) will be receiving the best available knee treatment including exercises only. Patients will receive a total of 18 sessions, 5 treatment sessions per week for four successive weeks. The data will be entered and analyzed using SPPS version 21. Repeated mean one way ANOVA will be applied to measure VAS and KOOS scores within the group, for pairwise comparison between groups, Tukey's test will be applied. Chi-square will be applied for FSST scoring. A P-Value less than 0.5 will be considered significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 15, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

2.6 years

First QC Date

February 21, 2021

Last Update Submit

January 27, 2022

Conditions

Keywords

Knee Osteo-arthritisMusculoskeletallower extremity manual therapyclinical trial Manual therapyResistance trainingposture

Outcome Measures

Primary Outcomes (3)

  • Visual analog scale

    Visual analog scale (VAS) is a tool evaluating subjective attitudes that cannot be directly measurable, it has a good Test-retest reliability. This scoring range from 0 to 10 cm, Where 0 stands for no pain and 10 indicates worse possible pain.

    up to 6 weeks

  • Four step square test

    Four square step tests is a tool for assessing the dynamic balance and mobility while standing. It also assess the fall risk.

    up to 6 weeks

  • Koos

    The Knee Injury and Osteoarthritis Outcome Score is a PROM having five sub scales used for knee osteoarthritis (OA), it monitors the course of disease and final outcomes following interventions. Each subscale is scored from 0 (extreme problems) to 100 (no problems). It has high test-retest reliability.

    up to 6 weeks

Study Arms (3)

Hip Joint Mobilizations

EXPERIMENTAL

Hip joint mobilizations Hip strength training Knee exercises

Other: Hip Joint MobilizationsOther: Hip joint Muscle strength trainingOther: knee strengthening and flexibility exercises

Hip & Knee Muscles strength training

EXPERIMENTAL

Hip strength training Knee exercises

Other: Hip joint Muscle strength trainingOther: knee strengthening and flexibility exercises

Knee Muscles strength training

ACTIVE COMPARATOR

Knee exercises

Other: knee strengthening and flexibility exercises

Interventions

i. Anterior-posterior glide ii. Posterior-anterior glide iii. Caudal glide iv. Posterior-anterior glide with Abduction, flexion, and lateral rotation

Hip Joint Mobilizations

i. Hip abduction in side-lying ii. Hip extension in the prone position iii. Sideways walk iv. Hip abduction in stand up position v. Hip hitching

Hip & Knee Muscles strength trainingHip Joint Mobilizations

i. STRENGTHENING EXERCISES: Knee extension static quads set, terminal knee extension while standing up, sitting leg press, partial squat, step-ups. ii. STRETCHING EXERCISES:: stretching of the calf, hamstring, and quadriceps-femoris. iii. RANGE OF MOTION EXERCISES: Knee in mid-flexion to full-extension, Knee in mid-flexion to full-flexion:

Hip & Knee Muscles strength trainingHip Joint MobilizationsKnee Muscles strength training

Eligibility Criteria

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

You may qualify if:

  • Patients with unilateral or bilateral knee OA.
  • Subjects of 50 years or above
  • palpable bony enlargement
  • Crepitus on knee motion
  • morning stiffness for less than 30 minutes
  • Kellgren and Lawrence scale: Grade 1-3

You may not qualify if:

  • Patients with spinal surgery
  • lower extremity arthroplasty
  • Severe joint contractures and bony deformities of lower extremity
  • Amputation of lower extremity
  • Recent trauma to lower extremity
  • A cortisone injection to the hip/ knee within previous 30 days
  • Patient having mechanical back pain .i.e. lumbosacral radiculopathy and sciatica
  • Patient with lower extremity bony deformities either acquired or congenital
  • Patient with advanced hip OA.
  • Systemic arthritis or rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 75400, Pakistan

Location

Related Publications (22)

  • Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.

    PMID: 24024017BACKGROUND
  • Mora JC, Przkora R, Cruz-Almeida Y. Knee osteoarthritis: pathophysiology and current treatment modalities. J Pain Res. 2018 Oct 5;11:2189-2196. doi: 10.2147/JPR.S154002. eCollection 2018.

    PMID: 30323653BACKGROUND
  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

    PMID: 24553908BACKGROUND
  • Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.

    PMID: 28808025BACKGROUND
  • Iqbal MN, Haidri FR, Motiani B, Mannan A. Frequency of factors associated with knee osteoarthritis. J Pak Med Assoc. 2011 Aug;61(8):786-9.

    PMID: 22356003BACKGROUND
  • Ro DH, Lee J, Lee J, Park JY, Han HS, Lee MC. Effects of Knee Osteoarthritis on Hip and Ankle Gait Mechanics. Adv Orthop. 2019 Mar 24;2019:9757369. doi: 10.1155/2019/9757369. eCollection 2019.

    PMID: 31019809BACKGROUND
  • A. Tanvi, R. Amrita, R. Deepak, P. Kopa. Comparison of effect of hip joint mobilization and hip joint muscle strengthening exercises with knee osteoarthritis. Scientific Research Journal of India. 2014;3

    BACKGROUND
  • Currier LL, Froehlich PJ, Carow SD, McAndrew RK, Cliborne AV, Boyles RE, Mansfield LT, Wainner RS. Development of a clinical prediction rule to identify patients with knee pain and clinical evidence of knee osteoarthritis who demonstrate a favorable short-term response to hip mobilization. Phys Ther. 2007 Sep;87(9):1106-19. doi: 10.2522/ptj.20060066. Epub 2007 Jul 3.

    PMID: 17609333BACKGROUND
  • Cliborne AV, Wainner RS, Rhon DI, Judd CD, Fee TT, Matekel RL, Whitman JM. Clinical hip tests and a functional squat test in patients with knee osteoarthritis: reliability, prevalence of positive test findings, and short-term response to hip mobilization. J Orthop Sports Phys Ther. 2004 Nov;34(11):676-85. doi: 10.2519/jospt.2004.34.11.676.

    PMID: 15609488BACKGROUND
  • Ahmad A, Daud M. A COMPARATIVE STUDY BETWEEN JOINT MOBILIZATION AND CONVENTIONAL PHYSIOTHERAPY IN KNEE OSTEOARTHRITIS. Int J Physio [Internet]. 2016Apr.8 [cited 2021Feb.2];3(2):159-62. Available from: https://www.ijphy.org/index.php/journal/article/view/207

    BACKGROUND
  • A. Tanvi, R. Amrita, R. Deepak, P. Kopa.Comparison of effect of hip joint mobilization and hip joint muscle strengthening exercises with knee osteoarthritis. Scientific Research J of Ind 2014;3(1)

    BACKGROUND
  • Santos TR, Oliveira BA, Ocarino JM, Holt KG, Fonseca ST. Effectiveness of hip muscle strengthening in patellofemoral pain syndrome patients: a systematic review. Braz J Phys Ther. 2015 May-Jun;19(3):167-76. doi: 10.1590/bjpt-rbf.2014.0089. Epub 2015 May 29.

    PMID: 26039034BACKGROUND
  • Bennell KL, Hunt MA, Wrigley TV, Hunter DJ, McManus FJ, Hodges PW, Li L, Hinman RS. Hip strengthening reduces symptoms but not knee load in people with medial knee osteoarthritis and varus malalignment: a randomised controlled trial. Osteoarthritis Cartilage. 2010 May;18(5):621-8. doi: 10.1016/j.joca.2010.01.010. Epub 2010 Feb 6.

    PMID: 20175973BACKGROUND
  • Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x.

    PMID: 27295978BACKGROUND
  • Moore M, Barker K. The validity and reliability of the four square step test in different adult populations: a systematic review. Syst Rev. 2017 Sep 11;6(1):187. doi: 10.1186/s13643-017-0577-5.

    PMID: 28893312BACKGROUND
  • Collins NJ, Prinsen CA, Christensen R, Bartels EM, Terwee CB, Roos EM. Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis Cartilage. 2016 Aug;24(8):1317-29. doi: 10.1016/j.joca.2016.03.010. Epub 2016 Mar 21.

    PMID: 27012756BACKGROUND
  • Alviar MJ, Olver J, Brand C, Hale T, Khan F. Do patient-reported outcome measures used in assessing outcomes in rehabilitation after hip and knee arthroplasty capture issues relevant to patients? Results of a systematic review and ICF linking process. J Rehabil Med. 2011 Apr;43(5):374-81. doi: 10.2340/16501977-0801.

    PMID: 21448553BACKGROUND
  • Gould D, Kelly D, Goldstone L, Gammon J. Examining the validity of pressure ulcer risk assessment scales: developing and using illustrated patient simulations to collect the data. J Clin Nurs. 2001 Sep;10(5):697-706. doi: 10.1046/j.1365-2702.2001.00525.x.

    PMID: 11822520BACKGROUND
  • Hanrahan S, Van Lunen BL, Tamburello M, Walker ML. The Short-Term Effects of Joint Mobilizations on Acute Mechanical Low Back Dysfunction in Collegiate Athletes. J Athl Train. 2005 Jun;40(2):88-93.

    PMID: 15970954BACKGROUND
  • Philadelphia Panel. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for knee pain. Phys Ther. 2001 Oct;81(10):1675-700.

    PMID: 11589643BACKGROUND
  • Hengeveld E, Banks K.(ed) Maitland's Peripheral Manipulation. 4th ed. Elsevier: London.(2005)

    BACKGROUND
  • Mehwish B, Ali SS, Mirza Baig AA. Effect of hip joint mobilisations and strength training on pain, physical function and dynamic balance in patients with Knee Osteoarthritis: A randomized controlled trial. J Pak Med Assoc. 2023 Apr;73(4):749-754. doi: 10.47391/JPMA.6223.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Bushra Mehwish, MSAPT

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Shahzad Ali Syed, MSPT

    Dow University of Health Sciences

    STUDY DIRECTOR
  • Aftab Ahmed Mirza Baig, MSAPT

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
After enrolling the patient, informed consent will be taken from each taken. All patients will be blinded to the type of information to avoid biasness.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It is a randomized control trial. Total 66 patients will be carry out, 22 in each of the three groups that include 2 patients as a drop out per group. There will be two interventional groups and one control group. Treatment will be allocated normally using random number sheet generated by statistician.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 24, 2021

Study Start

January 15, 2019

Primary Completion

August 30, 2021

Study Completion

December 30, 2021

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations