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CTRI Number  CTRI/2023/11/059579 [Registered on: 06/11/2023] Trial Registered Prospectively
Last Modified On: 17/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Immediate Effect of Combined Muscle Energy Technique of Iliopsoas and Quadratus Lumborum v/s Muscle Energy Technique of Iliopsoas and Quadratus Lumborum individually on Pain and Transversus Abdominis activation in young adults with Sub-Acute Non-Specific Low Back Pain 
Scientific Title of Study   Immediate Effect of Combined Muscle Energy Technique of Iliopsoas and Quadratus Lumborum v/s Muscle Energy Technique of Iliopsoas and Quadratus Lumborum individually on Pain and Transversus Abdominis activation in young adults with Sub-Acute Non-Specific Low Back Pain: An Experimental Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Esha Sawant  
Designation  Master of Physiotherapy Student 
Affiliation  K J Somaiya College Of Physiotherapy 
Address  OPD 5 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai Mumba
OPD 5 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai Mumba
Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  8879563822  
Fax    
Email  esha.sawant@somaiya.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Priti Mehendale  
Designation  Professor and Head Of Department of Kinesiotherapy 
Affiliation  K J Somaiya College Of Physiotherapy 
Address  OPD 5 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai Mumba
OPD 5 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai Mumba
Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9821533846  
Fax    
Email  priti.mehendale@somaiya.edu  
 
Details of Contact Person
Public Query  
Name  Dr Priti Mehendale  
Designation  Professor and Head Of Department of Kinesiotherapy 
Affiliation  K J Somaiya College Of Physiotherapy 
Address  OPD 5 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai Mumba
OPD 5 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai Mumba
Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9821533846  
Fax    
Email  priti.mehendale@somaiya.edu  
 
Source of Monetary or Material Support  
K J Somaiya College of Physiotherapy, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai 400022 
 
Primary Sponsor  
Name  K J Somaiya College of Physiotherapy 
Address  OPD No 4 and 5, Department of Musculoskeletal Physiotherapy, K J Somaiya College Of Physiotherapy, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai 
Type of Sponsor  Research institution and hospital 
 
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 Esha Sawant  K J Somaiya College Of Physiotherapy  OPD No 4 and 5, Department of Musculoskeletal Physiotherapy, K J Somaiya College of Physiotherapy, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai 400022
Mumbai (Suburban)
MAHARASHTRA 		 8879563822

esha.sawant@somaiya.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
K J Somaiya College of Physiotherapy Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Combination of Muscle Energy technique Iliopsoas and Quadratus Lumborum  Muscle Energy Technique(MET) is defined as a “treatment protocol involving the use of voluntary contraction of muscles in a precisely controlled direction, against a distinct counterforce and against varying levels of intensity applied by the therapist.”It is an active treatment maneuver that uses the patient’s own efforts to bring about desired effects. It is claimed to be effective for various purposes mainly to lengthen shortened muscles, reduce overactivity in muscles, enhance the flexibility of muscles, increase the range of motion of restricted joints, improve blood and lymph drainage, and to reduce pain and functional disability. The effect of the technique will be observed immediately after the application of the technique. 
Intervention  Muscle Energy Technique of Iliopsoas muscle   Muscle Energy Technique (MET) is defined as a “treatment protocol involving the use of voluntary contraction of muscles in a precisely controlled direction, against a distinct counterforce and against varying levels of intensity applied by the therapist.”It is an active treatment maneuver that uses the patient’s own efforts to bring about desired effects. It is claimed to be effective for various purposes mainly to lengthen shortened muscles, reduce overactivity in muscles, enhance the flexibility of muscles, increase the range of motion of restricted joints, improve blood and lymph drainage, and to reduce pain and functional disability. The effect of the technique will be observed immediately after the application of the technique.  
Comparator Agent  Muscle Energy Technique of Quadratus Lumborum  Muscle Energy Technique(MET) is defined as a “treatment protocol involving the use of voluntary contraction of muscles in a precisely controlled direction, against a distinct counterforce and against varying levels of intensity applied by the therapist.”It is an active treatment maneuver that uses the patient’s own efforts to bring about desired effects. It is claimed to be effective for various purposes mainly to lengthen shortened muscles, reduce overactivity in muscles, enhance the flexibility of muscles, increase the range of motion of restricted joints, improve blood and lymph drainage, and to reduce pain and functional disability. The effect of the technique will be observed immediately after the application of the technique. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Individuals in the age group 20 to 40 years with Subacute (6 weeks to 12 weeks) Nonspecific Low back pain (VAS score 4 to 7) 
 
ExclusionCriteria 
Details  1) Recent trauma to the Lumbar spine, hip, knee, and ankle
2) Recent lumbar surgeries
3) Congenital, Infective, Inflammatory diseases of the Lumbar spine, hip,
knee, and ankle
4) Systemic diseases (Arthritis, Tuberculosis)
5) Radiculopathies, Degenerative disc disease
6) Cognitive and mental impairments
7) Subject already seeking physiotherapy treatment 
 
Method of Generating Random Sequence    
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Goniometer and Tape measure to assess muscle length of Iliopsoas and Quadratus Lumborum respectively
Pressure Biofeedback unit  		 Pre-intervention: Baseline assessment
Post-intervention: Immediately after 1st session 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   13/11/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 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 an experimental study that will compare the immediate effects of the combined Muscle Energy Technique of Iliopsoas and Quadratus Lumborum to the muscle energy technique of Iliopsoas and Quadratus Lumborum Individually on Subacute Nonspecific Low Back pain and Transversus Abdominis Activation. Individuals meeting the inclusion criteria will be selected and divided into three groups. Group A would receive Muscle Energy technique of Iliopsoas and Quadratus Lumborum Group B would receive Muscle Energy Technique of Iliopsoas and Group C would receive Muscle Energy Technique of Quadratus Lumborum.  Pre-assessment of pain will be done using Visual Analogue Scale and assessment of Transversus Abdominis Activation will be done using a Pressure Biofeedback unit. Assessment of muscle length of Iliopsoas and Quadratus Lumborum will also be performed. After the appropriate intervention is given to the participant depending upon which group they belong to, assessment of low back pain, Transversus abdominis activation and muscle length testing of Iliopsoas and Quadratus Lumborum muscles will be done again using the same methods. Statistical analysis will be done to compare the groups. The study aims to compare the immediate effects of Muscle Energy Technique of combined Iliopsoas and Quadratus Lumborum and Muscle Energy Technique of Iliopsoas and Quadratus Lumborum individually. 
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