NCT06954363

Brief Summary

This study aims to evaluate the effectiveness of integrating Muscle Energy Technique (MET) and Mulligan Mobilization with conventional physical therapy in the management of knee osteoarthritis (OA), with a specific focus on improving hamstring flexibility and reducing functional limitations. The findings will help inform clinical decision-making and enhance patient outcomes in OA rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

3 active sites

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

April 1, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

April 24, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

Knee OsteoarthritisMuscle Stretching ExercisesRange of Motion, Articular

Outcome Measures

Primary Outcomes (4)

  • Hamstring Flexibility Measured by Goniometer

    Hamstring range of motion (ROM) will be assessed using a goniometer before and after the intervention. The change in ROM will be used to evaluate effectiveness. Outcome improvement categories: Mild Increase: 5-10 degrees Moderate Increase: 10-15 degrees Marked Increase: \>15 degrees

    Baseline (Day 1) and Post-treatment (End of Week 3)

  • Change in Pain Score Using Knee Osteoarthritis Outcome Score-12 questionnaire Questionnaire

    The function in daily activities subscale of Knee Osteoarthritis Outcome Score-12 questionnaire will assess participants' ability to perform routine activities before and after the intervention.

    Baseline (Day 1) and Post-treatment (End of Week 3)

  • Change in Knee-Related Quality of Life Using Knee Osteoarthritis Outcome Score-12 questionnaire

    The quality of life (QOL) subscale of KOOS-12 will evaluate the impact of osteoarthritis on participants' knee-related wellbeing pre- and post-treatment.

    Baseline (Day 1) and Post-treatment (End of Week 3)

  • Change in Activity of Daily Living Function Using KOOS-12

    The function in daily activities subscale of KOOS-12 will assess participants' ability to perform routine activities before and after the intervention.

    Baseline (Day 1) and Post-treatment (End of Week 3)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this group will receive Mulligan Mobilization combined with Conventional Physical Therapy. Mulligan Mobilization includes medial and lateral tibial glides using a Mulligan belt. Each session will consist of 3 sets of 10 repetitions, administered 5 days a week for 3 weeks. In addition, patients will undergo standard conventional physical therapy exercises such as quadriceps strengthening, straight leg raising, and stretching exercises. Each treatment session will last 30 minutes.

Procedure: Mulligan Mobilization

Control Group

ACTIVE COMPARATOR

Participants in this group will receive Muscle Energy Technique (MET) targeting the hamstring muscles, in combination with Conventional Physical Therapy. The MET will follow a post-isometric relaxation approach, using both direct and indirect methods depending on patient condition. Each isometric contraction will be held for 10 seconds, followed by a 20-second stretch, repeated for 3 sets. Therapy will be conducted 5 days a week over a 3-week period. Each session will last 30 minutes. The same conventional physical therapy regimen as the intervention group will be applied.

Procedure: Muscle Energy Technique (MET)

Interventions

Mulligan Mobilization involves manual tibial glides (medial and lateral) using a mobilization belt. The patient lies supine with the knee flexed between 30°-45°. The therapist applies a sustained glide while the patient actively moves the knee into flexion and extension. The treatment is delivered in 3 sets of 10 repetitions per session, 5 days per week for 3 weeks, along with a conventional physical therapy protocol.

Intervention Group

Muscle Energy Technique involves the application of post-isometric relaxation targeting hamstring muscles. The therapist applies a 10-second isometric contraction at the resistance barrier, followed by a 20-second passive stretch, progressing into a new range of motion. This technique is applied 3 times per session, 5 days per week for 3 weeks, in combination with a conventional physical therapy protocol.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed cases of osteoarthritis (Grade 1 to 3)
  • X-ray showing Grades I to III on Kellgren Lawrence scale of Osteoarthritis.
  • Residents of Peshawar verified via NADRA CNIC
  • Both genders will be included with unilateral or bilateral knee involvement.
  • Age group 40 and above.
  • Duration of Knee pain for more than 3 months.

You may not qualify if:

  • History of any previously known neurological conditions i.e. stroke, peripheral neuropathy
  • Fractures in treatment limb.
  • Suspicious of malignancy around the knee joint.
  • Recent under gone surgery
  • Recent Intra-articular injection.
  • Significant comorbid diseases and disabilities are excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hayatabad Medical Complex Peshawar

Peshawar, KPK, 25000, Pakistan

Location

Alkhidmat Hospital Peshawar

Peshawar, KPK, Pakistan

Location

Bibi Zahida Memorial Hospital, NCS University System

Peshawar, KPK, Pakistan

Location

Related Publications (5)

  • Farazdaghi M, Kordi Yoosefinejad A, Abdollahian N, Rahimi M, Motealleh A. Dry needling trigger points around knee and hip joints improves function in patients with mild to moderate knee osteoarthritis. J Bodyw Mov Ther. 2021 Jul;27:597-604. doi: 10.1016/j.jbmt.2021.04.011. Epub 2021 Apr 30.

    PMID: 34391293BACKGROUND
  • Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effects of dry needling on pain, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis: Secondary analysis of a randomized controlled trial. Complement Ther Med. 2020 Jun;51:102443. doi: 10.1016/j.ctim.2020.102443. Epub 2020 May 18.

    PMID: 32507443BACKGROUND
  • Ashraf F, Anwar K, Arshad H. Effects of muscle energy technique along conventional physical therapy after mesenchymal stem cell transplantation in knee osteoarthritis patients. Pak J Med Sci. 2024 Dec;40(11):2558-2564. doi: 10.12669/pjms.40.11.9605.

    PMID: 39634887BACKGROUND
  • Goksen A, Can F, Yilmaz S, Korkusuz F. Comparison of different neuromuscular facilitation techniques and conventional physiotherapy in knee osteoarthritis. Turk J Med Sci. 2021 Dec 13;51(6):3089-3097. doi: 10.3906/sag-2101-298.

    PMID: 34565133BACKGROUND
  • Sanchez-Romero EA, Pecos-Martin D, Calvo-Lobo C, Ochoa-Saez V, Burgos-Caballero V, Fernandez-Carnero J. Effects of dry needling in an exercise program for older adults with knee osteoarthritis: A pilot clinical trial. Medicine (Baltimore). 2018 Jun;97(26):e11255. doi: 10.1097/MD.0000000000011255.

    PMID: 29952993BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Babar Israr, MSPT

    Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar

    PRINCIPAL INVESTIGATOR
  • Shakir Ullah, PhD

    Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar

    STUDY DIRECTOR
  • Samra Farid, MSPT

    Alkhidmat Hospital Peshawar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The study will utilize a single-blinded design, where the patients will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel treatment groups that includes experimental Group (Mulligan Mobilization + Conventional Physical Therapy) and Control Group (Muscle Energy Technique + Conventional Physical Therapy).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 1, 2025

Study Start

April 1, 2025

Primary Completion

October 30, 2025

Study Completion

November 28, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The study will make individual participant data (IPD) available to other researchers after the conclusion of the study. The IPD shared will include anonymized data related to the primary and secondary outcome measures, including depression scores, biochemical markers (e.g., TNF-α, IL-6, BDNF), EEG data, and other relevant clinical and demographic data collected during the trial. The data will be de-identified to ensure participant confidentiality. The data will be shared through an approved data repository or by direct request to the study's primary investigators.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will be made available 6 months after the study's completion and will remain accessible for a period of 5 years to facilitate further research.
Access Criteria
Access to the data will be granted to qualified researchers upon submission of a formal request that includes a research proposal outlining the intended use of the data. Requests will be reviewed by the study investigators and ethical review committee to ensure compliance with data privacy regulations.

Locations