NCT06444945

Brief Summary

This study is a randomised controlled trial and the purpose of this study is to determine the Effects of Mulligan mobilization with movement as compared to Kaltenborn joint mobilization in the management of knee osteoarthritis." To determine the effects of Mulligan MWM as compared to Kaltenborn joint mobilization in terms of pain, function, range of motion and gait in persons with 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
40

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

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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)

  • knee pain

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

    2 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

    2 weeks

  • Knee range of motion

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

    2 weeks

  • Stride length

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

    2 weeks

  • Gait velocity

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

    2 weeks

  • Isometeric Muscle Strength

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

    2 weeks

  • Walking related performance fatigability

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

    2 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.

    2 weeks

Study Arms (2)

Mulligan MWM group

EXPERIMENTAL

Group A receiving Mulligan MWM joint mobilization

Device: Heating padDevice: Transcutaneous electrical nerve stimulation(TENS)Procedure: Mulligan mobilization with movement (MWM)Procedure: Resistance Training exercise

Kaltenborn mobilization group

EXPERIMENTAL

Group B receiving Kaltenborn Joint mobilization

Device: Heating padDevice: Transcutaneous electrical nerve stimulation(TENS)Procedure: Kaltenborn joint mobilizationProcedure: Resistance Training exercise

Interventions

Heating pad will be used for heating purpose.

Kaltenborn mobilization groupMulligan MWM group

TENS is used for symptomatic pain relief

Kaltenborn mobilization groupMulligan MWM group

It provides short term pain relief and to restore pain-free, functional movements by achieving full range at the joint

Mulligan MWM group

The purpose of joint mobilization is to restore normal, painless joint function. In restricted joints, this involves the restoration of joint play to normalize the roll-gliding that is essential to active movement.

Kaltenborn mobilization group

Resistance training increases muscle strength by making your muscles work against a weight or force.

Kaltenborn mobilization groupMulligan MWM group

Eligibility Criteria

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

You may qualify if:

  • Individuals aged 40-70 years (Osama et al, 2022)
  • Having KOA history of no less than 3 months
  • Knee pain less than 8/10 on numeric pain rating scale (NPRS).
  • Radiological evidence of grade III or less on Kellgren classification
  • Patients referred from rehab department

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.
  • Receiving intra-articular steroid therapy in the preceding two months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcutaneous Electric Nerve StimulationMovementResistance Training

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyAftercareContinuity of Patient CarePatient CarePhysical Conditioning, HumanExerciseMotor Activity

Study Officials

  • Shanza Fatima, 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: Parallel designed randomized control trial
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

Locations