Does Adding Real or Fake Muscle Stretching Techniques to Regular Physiotherapy Help with Pain, Movement, Daily Activities, and Mental Health in People with General Low Back Pain. A Study with Randomly Chosen Groups.
Scientific Title of Study
EFFICACY OF MUSCLE ENERGY TECHNIQUE VS SHAM MUSCLE ENERGY TECHNIQUE IN ADJUNCT TO CONVENTIONAL PHYSIOTHERAPY ON PAIN, RANGE OF MOTION, FUNCTIONAL DISABILITY AND PSYCOLOGICAL COMORBIDTIES IN NON SPECIFIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Prachi Koche
Designation
Junior Resident
Affiliation
Ravi Nair Physiotherapy College
Address
Ravi Nair PHysiotherapy College Datta Meghe Institute Of Higher Education and Research sawangi Wardha
Wardha MAHARASHTRA 442001 India
Phone
8329430485
Fax
Email
prachikoche9@gmail.com
Details of Contact Person Scientific Query
Name
Dr Mitushi Deshmukh
Designation
Associate Professor
Affiliation
Ravi Nair Physiotherapy College
Address
Ravi Nair PHysiotherapy College Datta Meghe Institute Of Higher Education and Research sawangi Wardha
Wardha MAHARASHTRA 442001 India
Phone
9822220906
Fax
Email
mitushideshmukh11@gmail.com
Details of Contact Person Public Query
Name
Prachi Koche
Designation
Junior Resident
Affiliation
Ravi Nair Physiotherapy College
Address
Ravi Nair PHysiotherapy College Datta Meghe Institute Of Higher Education and Research sawangi Wardha
Wardha MAHARASHTRA 442001 India
Phone
8329430485
Fax
Email
prachikoche9@gmail.com
Source of Monetary or Material Support
Ravi Nair Physiotherapy College, sawangi, wardha 442001, India
Datta meghe institute of higher education and research
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Muscle Energy Technique
The study involves comparing Muscle Energy Technique (MET) combined with conventional therapy to sham MET with conventional therapy for individuals with chronic nonspecific low back pain.
In Group A, MET will be applied to targeted muscles using isometric contractions and passive stretching, lasting 5–10 minutes per session, three times a week for 4–6 weeks, followed by conventional therapy.
Group B will receive sham MET, mimicking the MET procedure without therapeutic effects, with the same duration and frequency as Group A, also followed by conventional therapy.
Both groups will be assessed for pain, range of motion, functional disability, and psychological comorbidities at baseline, mid-intervention, and post-intervention.
Comparator Agent
Sham Muscle Energy Technique
Participants in the control group will receive sham MET.
It is designed to mimic the physical setup of MET but without delivering its therapeutic effects.
Sham MET will involve gentle non-specific positioning and light touch, without inducing muscle contraction or stretching.
The duration and frequency of sham MET will match that of the actual MET sessions. This is done to maintain blinding and uniformity in treatment exposure between the two groups.
Inclusion Criteria
Age From
20.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
Willingness to participate and provide written informed consent.
Stable medical condition with no contraindications to physical therapy.
Subjects having chronic non specific low back pain.
ExclusionCriteria
Details
History of systemic disorders affecting outcomes eg rheumatoid arthritis
Recent surgery more than 6 months unrelated to the study focus.
Cognitive impairments or inability to follow instructions.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Pain- Assessed using the Visual Analog Scale (VAS) to measure the intensity of pain at rest and during activity.
Range of Motion (ROM): Measured using a goniometer to evaluate joint mobility in degrees.
baseline 2 weeks
Secondary Outcome
Outcome
TimePoints
Back Pain functional Scale
Psychological inflexibility in pain scale
baseline 2 weeks
Target Sample Size
Total Sample Size="70" Sample Size from India="70" 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)
15/05/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Informed Consent Form
Who will be able to view these files? Response - Researchers who provide a methodologically sound proposal.
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response - Proposals should be directed to [prachikoche9@gmail.com].
For how long will this data be available start date provided 18-03-2025 and end date provided 18-03-2030? Response - Beginning 9 months and ending 36 months following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
This research study aims to evaluate the effectiveness of Muscle Energy Technique (MET) in treating chronic nonspecific low back pain. It is a randomized controlled trial that will compare MET combined with conventional therapy to sham MET combined with conventional therapy.
Participants will be divided into two groups. Group A will receive MET, a manual therapy that uses muscle contractions and stretching, along with conventional physiotherapy exercises. Group B will receive sham MET, a placebo treatment that mimics MET without the therapeutic effects, combined with the same conventional therapy.
The study will assess the impact of these interventions on pain, range of motion, functional disability, and psychological comorbidities.
Data will be collected at baseline, during, and after the treatment period to compare the outcomes between the two groups