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CTRI Number  CTRI/2025/08/092782 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Improving Back Muscle Function with a Gentle Stretching Technique in People with Low Back Pain. 
Scientific Title of Study   Immediate effects of muscle energy technique on flexion relaxation phenomenon among individuals with non-specific low back pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Sanjay Maniyar 
Designation  BPT, MPT Student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal college of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9370105677  
Fax    
Email  maniyar.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Mr. Ganesh Balthillaya 
Designation  Assistant Professor- Selection Grade 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal college of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9448263631  
Fax    
Email  ganesh.bm@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ankita Sanjay Maniyar 
Designation  BPT, MPT Student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal college of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka- 576104


KARNATAKA
576104
India 
Phone  9370105677  
Fax    
Email  maniyar.mchpmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka- 576104 
 
Primary Sponsor  
Name  Ankita Maniyar 
Address  Department of Physiotherapy, Manipal college of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka- 576104 
Type of Sponsor  Other [Self Sponsor] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ganesh Balthillaya  Kasturba Medical hospital, Manipal  Outpatient Department of Physiotherapy, Kasturba Medical Hospital, Manipal Academy of Higher Education, Manipal, Karnataka- 576104
Udupi
KARNATAKA 		 9448263631

ganesh.bm@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Muscle Energy Technique (MET) for low back  Intervention Details: The intervention involves the application of Muscle Energy Technique (MET) to the erector spinae muscles in participants with non-specific low back pain. Type of Intervention- Physiotherapy/ Manual Therapy. Participant Position: The participant will be seated in a high sitting position on the treatment table, legs hanging and hands clasped behind the neck or hanging. Procedure: The therapist will assess and identify the restricted movement pattern in the lumbar spine, such as lumbar flexion and/or sideflexion and/or rotation, based on clinical findings. The participant will be passively moved by the therapist into the barrier of the restricted range of motion (e.g., flexion/sideflexion/rotation). The participant will then be instructed to perform an isometric contraction by attempting to return to the neutral/starting position while the therapist applies equal counter-resistance to prevent actual movement. This contraction will be held for 7 seconds. Upon relaxation, the therapist will again gently move the participant further into the new range of motion and hold the stretch for 30 seconds. This cycle of isometric contraction followed by passive stretching will be repeated for 5–7 repetitions, depending on participant tolerance and improvement in range. Therapist Involvement: The intervention will be performed by a qualified physiotherapist trained in the application of MET. The therapist will monitor for any signs of discomfort and ensure proper technique and safety throughout the procedure. Total Duration: The entire MET intervention for the erector spinae will last approximately for 10 minutes. Frequency - Single session. Comparator - No control group, so NIL. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals aged 18- 60 years with non-specific low back pain more than 3 on a scale of 0 to 10 with difficulty in bending forward. 
 
ExclusionCriteria 
Details  People with acute pain which is very irritable, radiating pain, spinal tumors, spinal deformities, history of previous trauma or surgeries and any diagnosed low back pain condition will be excluded.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Flexion Relaxation Phenomenon (Electrical activity of Erector spinae muscle of lower back) using surface electromyography.  Immediately before and after the intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Pain and lower back range of motion.  Immediately before and after the intervention 
 
Target Sample Size   Total Sample Size="19"
Sample Size from India="19" 
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   Phase 2 
Date of First Enrollment (India)   20/08/2025 
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="0"
Months="8"
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 - NO
Brief Summary  

This is a single-arm interventional study conducted to assess the immediate effects of Muscle Energy Technique (MET) on the Flexion Relaxation Phenomenon (FRP), pain intensity, and lumbar range of motion in individuals with non-specific low back pain (NSLBP). NSLBP is commonly associated with altered muscle activation, pain, and limited mobility. The FRP, which refers to a normal reduction in lumbar muscle activity during full trunk flexion, is often absent in people with low back pain.

The study will include 19 participants aged 18 to 60 years who report a pain score greater than 3 on a 0 to 10 scale and have difficulty bending forward. Individuals with acute or radiating pain, spinal deformities, tumors, previous trauma or surgeries, or diagnosed spinal conditions will be excluded.

Participants will first undergo a baseline assessment using surface electromyography (EMG) to record lumbar muscle activity during forward bending. Lumbar range of motion will be measured using the Back Range of Motion (BROM) II device, and pain will be rated using the Numeric Pain Rating Scale. Then, MET will be applied to the lumbar erector spinae muscle, involving isometric contractions followed by stretching, repeated 5 to 7 times.

After the intervention, the same assessments (EMG, range of motion, and pain) will be repeated immediately. This study is conducted at the Physiotherapy Department, Kasturba Hospital, Manipal. The findings may help support the clinical use of MET in improving function and managing pain in NSLBP.

 
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