NCT05349565

Brief Summary

To determine the effectiveness of muscle energy technique along conventional physical therapy after mesenchymal stem cell transplantation in knee Osteoarthritis patients regarding Pain, range of motion, functional disability and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2022

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

First Submitted

Initial submission to the registry

April 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 13, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

April 21, 2022

Last Update Submit

July 12, 2023

Conditions

Knee Osteoarthritis

Keywords

Mesenchymal stem cells (MSCs),muscle energy technique (MET),rehabilitation protocol

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) is the simplest and most commonly used numeric scale to rate the pain from 0 (no pain) to 10 (worst pain).

    NPRS used to measure changes from baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.

Secondary Outcomes (3)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    WOMAC index used to measure changes from baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.

  • Goniometer (range of motion)

    baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.

  • SF-12 (quality of life)

    SF-12 used to measure changes from baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.

Study Arms (2)

CONVENTIONAL PHYSICAL THERAPY

ACTIVE COMPARATOR

TENS , Open chain knee flexion and extension, Calf stretch , Quad set

Other: CONVENTIONAL PHYSICAL THERAPY

MUSCLE ENERGY TECHNIQUE

EXPERIMENTAL

MET ( isometric contraction with 6-10 sec )

Other: MUSCLE ENERGY TECHNIQUE

Interventions

CONVENTIONAL PHYSICAL THERAPYOTHER

High frequency TENS for 10 mins, 3 days/week Ankle pumps for blood circulation 10 repetitions x1 set, 3 days/week. Heel slides10 repetitions x1 set, 3 days/week. Open chain knee flexion and extension 10 repetitions x1 set, 3 days/week. SLR (straight leg raise) 10 repetitions x1 set, 3 days/week. Calf stretch 10 repetitions x1 set, 3 days/week. Quad set 10 repetitions x1 set, 3 days/week. Total 6 sessions each consisting of 30-45 minutes

CONVENTIONAL PHYSICAL THERAPY
MUSCLE ENERGY TECHNIQUEOTHER

Experimental group treated by applying Muscle energy technique along conventional physical therapy. For MET patient is positioned at maximal comfort and lengthening while engaging the barrier and then patient is asked to perform isometric contraction with 6-10 sec hold and then release and lengthen the muscle 4-5 repetition x 1 set, 3days/week Total 6 sessions each consisting of 30-45 minutes

MUSCLE ENERGY TECHNIQUE

Eligibility Criteria

Age41 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female
  • Age \> 40 years
  • Knee osteoarthritis patients undergone mesenchymal stem cell transplantation.

You may not qualify if:

  • History of recent or past septic arthritis
  • Patients with neurological deficit
  • Uncontrolled diabetes
  • Malignancy
  • Vascular insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Regenerative medicine

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • KINZA ANWAR, MS-OMPT

    RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 27, 2022

Study Start

September 13, 2022

Primary Completion

July 8, 2023

Study Completion

July 10, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)