| CTRI Number |
CTRI/2025/08/092329 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Muscle energy technique for knee osteoarthritis. |
|
Scientific Title of Study
|
Effectiveness of muscle energy technique to strengthening of muscle in patients with knee osteoarthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farjana Sharmin |
| Designation |
Lecturer of BHPI, Consultant and OPD in-charge, Department of Physiotherapy, CRP, Savar, Dhaka |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Department of Physiotherapy, Room no: 2, CRP, Savar, Division
: Dhaka.
1343
Other |
| Phone |
01968399059 |
| Fax |
|
| Email |
ayeshaakterasha01234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Farjana Sharmin |
| Designation |
Lecturer of BHPI, Consultant and OPD in-charge, Department of Physiotherapy,CRP, Savar, Dhaka |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Department of Physiotherapy, Room no: 2, CRP, Savar, Division
: Dhaka.
1343
Other |
| Phone |
01968399059 |
| Fax |
|
| Email |
ayeshaakterasha01234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farjana Sharmin |
| Designation |
Lecturer of BHPI, Consultant and OPD in-charge, Department of Physiotherapy, CRP, Savar, Dhaka |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Department of Physiotherapy, Room no: 2, CRP, Savar, Division
: Dhaka.
1343
Other |
| Phone |
01968399059 |
| Fax |
|
| Email |
ayeshaakterasha01234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal unit, Department of Physiotherapy, Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka-1343. |
|
|
Primary Sponsor
|
| Name |
Sadia Akter Birhi |
| Address |
7/5, Binodbaid, Arapara, Savar, Dhaka |
| Type of Sponsor |
Other [Self Funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadia Akter Bithi PT |
Centre for the Rehabilitation of the Paralysed (CRP). |
Musculoskeletal Unit (Room: 5), Department of Physiotherapy, Centre for the Rehabilitation of the Paralysed (CRP), Savar, Division: Dhaka- 1343.
|
01968399059
sadiabithi01968@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre for the Rehabilitation of the Paralysed (CRP) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
1. Soft tissue release
2. Range of motion exercise
3. Isometric exercise
4. Strengthening exercise
5. Electrotherapy: IRR, UST |
| Intervention |
Muscle Energy Technique+ Conventional physiotherapy |
Muscle Energy Technique (MET)-1: a) Agonist contract and relax which is one of
the MET techniques was used in this study. For that, supine patient fully flexes the
hip on the affected side. The flexed knee was extended by the practitioner to the point
of resistance (identification barrier).
b) The calf of the treated leg was placed on the shoulder of the practitioner, who stands
facing the head of the table on the side of the treated leg. The practitioners one hand
holds the treated legs thigh to maintain stability when the barrier is being assessed.
The other leg was stabilized with the stabilizing belt.
c) The patient is asked to attempt to straighten the lower leg (i.g., extend the knee)
utilizing the antagonists to the hamstrings (quadriceps), employing 20% of the
strength in the quadriceps. This was resisted by the practitioner for 7-10 seconds.
d) Appropriate breathing instructions had given. The leg was then extended at the knee
to its new hamstring limit, after that passive stretch should be hold for 30 sec, followed
by relaxation. The procedure is then repeated. (Chaitow, L 2021)
Dosage and intensity: 4 contractions per treatment, with 3 seconds rest between each
contraction, around 4 weeks 3 times a week.
Progression: Progression by increasing the force given by the therapist and the patient
also increase the force against the therapist.
Muscle Energy Technique (MET)-2: a) The patient is in the prone lying with the leg
is rested on the bed.
b) The patient is then asked to flex the knee while employing 20% of the strength in
the hamstring. This will resist by the practitioner for 7-10 seconds.
c) Appropriate breathing instructions had given. The leg was then extended at the knee
to its new hamstring limit, after that passive stretch should be hold for 30 sec, followed
by relaxation. The procedure is then repeated. (Chaitow, L 2021)
Dosage and intensity: 4 contractions per treatment, with 3 seconds rest between each
contraction, around 4 weeks 3 times a week.
Progression: Progression by increasing the force given by the therapist and the patient
also increase the force against the therapist. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Both the genders will be included.
2. Radiologically and clinically diagnosed cases of Osteoarthritis knee by certified
Orthopedic surgeon or Physiotherapist.
3. Patients with muscle strength less than grade 5 according to manual muscle
testing.
4. Age group between 40 to 60 years.
5. Patients with Grade 2 or 3. Osteoarthritis knee using Kellgren - lawrence
classification. |
|
| ExclusionCriteria |
| Details |
1. Fractures or any other orthopedic condition in treatment limb.
2. Other knee joint pathologies e.g. Chondromalacia patella, plica syndrome.
3. Recent undergone surgery or any acute inflammatory problem.
4. The patients who are not co-operative during the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Muscle Strength by MMT |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain by NPRS, Range of Motion by Goniometer |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sadiabithi01968@gmail.com].
- For how long will this data be available start date provided 24-06-2025 and end date provided 01-01-2200?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to evaluate the
effectiveness of the Muscle Energy Technique (MET) in combination with
conventional physiotherapy in reducing pain, improving range of motion and muscle
strength in individuals with knee osteoarthritis. The study will be conducted
as a single-blinded randomized controlled trial (RCT) at the Centre for the
Rehabilitation of the Paralyzed (CRP), Savar, Bangladesh. Forty participants
diagnosed with knee osteoarthritis will be randomly allocated to either the
experimental group (MET + conventional physiotherapy) or the control group
(conventional physiotherapy alone). Outcome measures including pain intensity
(NPRS), range of motion (ROM), muscle strength (Manual Muscle Testing) will be
assessed at baseline and after 12 treatment sessions. The primary hypothesis is
that MET combined with conventional therapy will result in greater improvements
in pain, ROM and muscle strength compared to conventional therapy alone. The
findings of this study could offer evidence for incorporating MET into
rehabilitation protocols for patients with knee osteoarthritis.
|