NCT05131048

Brief Summary

In knee osteoarthritis patients, weakness of hip abductor muscles is considered an important contributing factor leading to the progression of the disease.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable knee-osteoarthritis

Status
unknown

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

November 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

November 11, 2021

Last Update Submit

November 11, 2021

Conditions

Keywords

osteoarthritishome-based exercise planfunctional disabilityobesity

Outcome Measures

Primary Outcomes (6)

  • intensity of Pain

    The numerical Pain Rating Scale will be used to measure pain.

    baseline data

  • intensity of Pain

    The numerical Pain Rating Scale will be used to measure pain.

    at the end of 6th week

  • Range of Motion

    A goniometer will be used to measure a range of motion.

    baseline data

  • Range of Motion

    A goniometer will be used to measure a range of motion.

    at the end of 6th week

  • Functional Disability

    KOOS Scale will be used to measure functional disability.

    baseline data

  • Functional Disability

    KOOS Scale will be used to measure functional disability.

    at the end of 6th week

Study Arms (2)

Conventional group

ACTIVE COMPARATOR

Patients will be given thermal therapy with the hot pack for 20 minutes followed by Conventional physiotherapy will consist of a set of exercises. The exercise components willl be chosen based on previous studies (Deyle 2000) and will comprises of * stretches of lower limb muscles (gastrocnemius, soleus and hamstring) * isometric quadriceps work * straight leg raising * Joint mobilization includes anteroposterior (AP) glide of the tibia on the femur * the patella glides in all directions Subjects will participate in a 45-minute physical therapy session, on alternate days weekly for 6 weeks, in our centre under the close surveillance of a physical therapist. A total of 24 sessions will be given to this group.

Other: conventional group

interventional group

EXPERIMENTAL

Patients in this group will perform home-based hip Strengthening exercises to strengthen hip abductor and adductor muscles. Six different home-based exercises will be taught. This group will have 3 sessions in 1st week in the hospital under the supervision of a trained physiotherapist just to teach them and ensure that patients are doing exercises correctly on their own. After that, patients will perform exercises 5 days at home and 1 session at the hospital per week. The therapist will be trained to deliver different exercises and adjust the intensity of exercise accordingly advise the participants to complete 10 repetitions of every exercise at home96. * Abduction in side-lying * Abduction in standing * Standing wall isometric hip abduction * Hip Adduction in side-lying * Hip abduction in a standing position * Towel press

Other: experimental group

Interventions

this group will perform conventional therapy

Conventional group

this group will perform home based exercises

interventional group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The age group was from 40 to 60 years.
  • Both males and females were included.
  • Average knee pain on walking \>3 on an 11-point scale (NPRS) (0 no pain; 10 maximal pain).
  • participants can walk independently without any assistive devices
  • Diagnosed patients of grade II \& III of Kallgren and Lawrence scale for knee osteoarthritis referred by an orthopaedic surgeon

You may not qualify if:

  • History of osteoporosis.
  • Leg length discrepancy or structural deformity
  • Knee surgery or TKR.
  • Corticosteroid injection in knee joint
  • Systemic arthritic condition
  • History of tibiofemoral and patellofemoral replacement
  • Any other neurological and muscular condition affecting the lower limb
  • Any history of radiculopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Valdes AM, McWilliams D, Arden NK, Doherty SA, Wheeler M, Muir KR, Zhang W, Cooper C, Maciewicz RA, Doherty M. Involvement of different risk factors in clinically severe large joint osteoarthritis according to the presence of hand interphalangeal nodes. Arthritis Rheum. 2010 Sep;62(9):2688-95. doi: 10.1002/art.27574.

    PMID: 20499385BACKGROUND
  • Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.

    PMID: 19751691BACKGROUND
  • Fatima S, Arslan SA, Sharif F, Ahmad A, Gillani SA, Zaheer A. Translation, cross-cultural adaptation and psychometric properties of the Urdu version of knee injury and osteoarthritis outcome score questionnaire for Pakistani population. BMC Musculoskelet Disord. 2021 Jun 26;22(1):592. doi: 10.1186/s12891-021-04477-1.

    PMID: 34174864BACKGROUND
  • Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.

  • Farrokhi S, Voycheck CA, Tashman S, Fitzgerald GK. A biomechanical perspective on physical therapy management of knee osteoarthritis. J Orthop Sports Phys Ther. 2013 Sep;43(9):600-19. doi: 10.2519/jospt.2013.4121.

  • Safran-Norton CE, Sullivan JK, Irrgang JJ, Kerman HM, Bennell KL, Calabrese G, Dechaves L, Deluca B, Gil AB, Kale M, Luc-Harkey B, Selzer F, Sople D, Tonsoline P, Losina E, Katz JN. A consensus-based process identifying physical therapy and exercise treatments for patients with degenerative meniscal tears and knee OA: the TeMPO physical therapy interventions and home exercise program. BMC Musculoskelet Disord. 2019 Nov 4;20(1):514. doi: 10.1186/s12891-019-2872-x.

  • Arhos EK, Thoma LM, Grindem H, Logerstedt D, Risberg MA, Snyder-Mackler L. Association of Quadriceps Strength Symmetry and Surgical Status With Clinical Osteoarthritis Five Years After Anterior Cruciate Ligament Rupture. Arthritis Care Res (Hoboken). 2022 Mar;74(3):386-391. doi: 10.1002/acr.24479. Epub 2022 Jan 19.

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisObesity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • faizan asghar

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 23, 2021

Study Start

November 1, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share