NCT04546659

Brief Summary

In osteoarthritis the most affected joint is knee due to degenerative changes. Degenerative changes cause age-related wear-and-tear and may be accelerated by injury, health and lifestyle factors, and possibly by genetic predisposition to joint pain or musculoskeletal disorders. Knee osteoarthritis causes pain, swelling \& stiffness in joint. Patients unable to perform ADL's and IADL's due to pain. Various treatment methods are used for management of knee osteoarthritis. But physiotherapy approach is best option for making patients independent after medical management. This study will be a randomized control trial, used to compare the effectiveness of retro-walking and conventional therapy to improve pain, functional disability and performance in knee osteoarthritic patient. Subjects with knee osteoarthritis meeting the predetermined inclusion \& exclusion criteria will divide into two groups using lottery method. Time up \& Go (TUG), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) \& Numeric Pain Rating Scale (NPRS) tools for screening will be used for data collection. Subjects in one group will be treated with retro-walking \& conventional therapy and other will be treated with conventional therapy. Each subject will receive a total 6 weeks treatment session, with 3 treatment sessions per week. Recorded values will be analyzed for any change using SPSS 21 version.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable knee-osteoarthritis

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

May 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

September 4, 2020

Last Update Submit

March 26, 2021

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritisknee jointpain

Outcome Measures

Primary Outcomes (1)

  • Western Ontario & Mc-master Osteoarthritis Index

    The WOMAC takes approximately 12 minutes to complete, and can be taken on paper, over the telephone or computer. Both the computerized and the mobile versions of the test have been found to be comparable to the paper form, with no significant difference. 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.

    12 weeks

Secondary Outcomes (2)

  • Time Up & Go Test

    12 weeks

  • Numeric Pain Rating Scale

    12 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Osteoarthritic patient receiving Conventional therapy and Retrowalking

Other: RetrowalkingOther: Conventional Therapy

Group B

ACTIVE COMPARATOR

Osteoarthritic patient receiving Conventional therapy

Other: Conventional Therapy

Interventions

RetrowalkingOTHER

Treatment of retro-walking including supervised 10 min retro-walking training with 5 min of warm-up and cool down on a flat surface at their comfortable speed

Group A
Conventional TherapyOTHER

Treatment of conventional therapy involve Isometric Quadriceps exercise, SLR, Isometric hip adduction exercises, Terminal knee extension exercise 1 set of 10 Reps twice a day.

Group AGroup B

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient suffering with Osteoarthritis knee for three months at least
  • Age ranges from 40-70
  • knee OA as per the American College of Rheumatology clinical and radiographic diagnostic criteria will participate
  • radiographic grades on the Kellgren-Lawrence scale
  • Both genders will be included
  • being able to cooperate
  • Bilateral knee osteoarthritis

You may not qualify if:

  • Traumatic knee pain, fractures or ruptured ligaments, meniscopathy of knee joint
  • Inflammatory and Infectious knee conditions (RA, gout, psoriatic arthritis)
  • Balance problem
  • Any recent surgical intervention of knee joint or those who had undergone arthroplasty
  • Surgeries in hip or knee
  • Tumors/malignancy of bone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, Pakistan

Location

Related Publications (5)

  • Goh SL, Persson MSM, Stocks J, Hou Y, Welton NJ, Lin J, Hall MC, Doherty M, Zhang W. Relative Efficacy of Different Exercises for Pain, Function, Performance and Quality of Life in Knee and Hip Osteoarthritis: Systematic Review and Network Meta-Analysis. Sports Med. 2019 May;49(5):743-761. doi: 10.1007/s40279-019-01082-0.

    PMID: 30830561BACKGROUND

  • Gondhalekar GA, Deo MV. Retrowalking as an adjunct to conventional treatment versus conventional treatment alone on pain and disability in patients with acute exacerbation of chronic knee osteoarthritis: a randomized clinical trial. N Am J Med Sci. 2013 Feb;5(2):108-12. doi: 10.4103/1947-2714.107527.

    PMID: 23641371BACKGROUND

  • Jeong HS, Lee SC, Jee H, Song JB, Chang HS, Lee SY. Proprioceptive Training and Outcomes of Patients With Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. J Athl Train. 2019 Apr;54(4):418-428. doi: 10.4085/1062-6050-329-17. Epub 2019 Apr 17.

    PMID: 30995119BACKGROUND

  • Black DW. Treatment of knee arthrofibrosis and quadriceps insufficiency after patellar tendon repair: a case report including use of the graston technique. Int J Ther Massage Bodywork. 2010 Jun 23;3(2):14-21.

    PMID: 21589706BACKGROUND

  • Chen ZH, Ye XL, Chen WJ, Chen GQ, Wu JT, Wu H, Xu XM. Effectiveness of backward walking for people affected by stroke: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Jul 2;99(27):e20731. doi: 10.1097/MD.0000000000020731.

    PMID: 32629648BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Hashim, PPDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 14, 2020

Study Start

May 1, 2020

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)