NCT06444932

Brief Summary

Joint mobilization and resistance exercise training are effective conservative treatment options for the management of osteoarthritis. However, currently no study has highlighted the supplementary effects of resistance training in addition to joint mobilization in people suffering from knee osteoarthritis. The current study is aimed at bridging the gap in literature and providing evidence regarding the additive impact of resistance training to joint mobilization in knee osteoarthritis.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

May 27, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

May 27, 2024

Last Update Submit

June 5, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Walking related performance fatigability

    Walking related performance fatigability will be measured using 6 minute walk test. Greater fatigability indicates poorer outcome.

    4 weeks

  • Stride Length

    Gait analysis will be done to analyze stride length. A greater stride length signifies positive outcome and prognosis.

    4 weeks

  • Gait velocity

    Gait analysis will be done to analyze gaot velocity. A greater gait velocity signifies positive outcome and prognosis.

    4 weeks

  • Knee Pain

    Knee Pain will be measured using visual analogue scale (VAS) from 0-100mm. A higher score on VAS indicated greater pain.

    4 weeks

  • Knee range of motion

    Knee range of motion will be measured using a goniometer. A higher ROM signifies positive outcome.

    4 weeks

  • Functional Disability

    Knee functional disability will be assessed using Knee Osteoarthritis and Outcome Score (KOOS) with a score ranging from 0-100. A lower score on KOOS signifies greater functional disability.

    4 weeks

  • Isometric Muscle Strength

    Isometric Muscle Strength will be quantified using dynamometer. A higher score on dynamometer signifies greater muscle strength and good prognosis.

    4 weeks

  • Functional capacity

    5 repetition sit to stand test will be used to determine knee related functional capacity, which will be quantified in terms of time. A smaller time will denote greater functional capacity.

    4 weeks

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR
Procedure: Joint MobilizationDevice: Transcutaneous Electric Nerve Stimulation (TENS)Device: Heating Pad

Experimental Group

EXPERIMENTAL
Procedure: Joint MobilizationProcedure: Resistance Exercise TrainingDevice: Transcutaneous Electric Nerve Stimulation (TENS)Device: Heating Pad

Interventions

Patellofemoral and tibiofemoral joint mobilization

Active ComparatorExperimental Group

Lower limb resistance exercise training

Experimental Group

Transcutaneous Electric Nerve Stimulation (TENS)

Active ComparatorExperimental Group

Heating pad for heat therapy

Active ComparatorExperimental Group

Eligibility Criteria

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

You may qualify if:

  • Knee OA grade I-III
  • Individuals of either gender aged 40-70 years
  • Knee OA history of no less than 3 months
  • Knee pain no more than 8/10 cm on the visual analogue scale (VAS)
  • Radiological evidence of grade III or less on Kellgren classification.

You may not qualify if:

  • Those with signs of serious pathology such as malignancy, inflammatory disorder or infection.
  • History of trauma or fractures in lower extremity
  • Signs of lumbar radiculopathy or myelopathy
  • History of knee surgery or replacement and/or receiving intra-articular steroid therapy in the preceding two months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation Univeristy Islamabad

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Resistance TrainingTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaElectric Stimulation TherapyAnalgesiaAnesthesia and Analgesia

Study Officials

  • Wania Maheen, DPT

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR
  • Muhammad Osama, PhD*

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double arm parallel design RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 6, 2024

Study Start

June 10, 2024

Primary Completion

December 10, 2024

Study Completion

December 30, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations