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CTRI Number  CTRI/2024/10/075868 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   This study looks at how using techniques that connect the mind and body can help improve sleep, reduce pain, and enhance the overall quality of life for people with ongoing lower back pain. 
Scientific Title of Study   Effect of Mind-Body Technique on sleep, pain and quality of life in non-specific chronic 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  Gouri R Dhumal 
Designation  PG Student 
Affiliation  MGM School Of Physiotherapy 
Address  Department of Musculoskeletal Physiotherapy, no. 1,MGM School of Physiotherapy, C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India

Aurangabad
MAHARASHTRA
431001
India 
Phone  7588878080  
Fax    
Email  gouridhumal9909@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rinkle Malani  
Designation  Director and Professor 
Affiliation  MGM School Of Physiotherapy 
Address  Department of Musculoskeletal Physiotherapy, no. 1,MGM School of Physiotherapy, C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India

Aurangabad
MAHARASHTRA
431001
India 
Phone  9370312412  
Fax    
Email  rinkle.malani@mgmsop.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Rinkle Malani  
Designation  Director and Professor 
Affiliation  MGM School Of Physiotherapy 
Address  Department of Musculoskeletal Physiotherapy, no. 1,MGM School of Physiotherapy, C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India

Aurangabad
MAHARASHTRA
431001
India 
Phone  9370312412  
Fax    
Email  rinkle.malani@mgmsop.edu.in  
 
Source of Monetary or Material Support  
MGM School of Physiotherapy,Chh. Sambhajinagar 
 
Primary Sponsor  
Name  MGM School of Physiotherapy 
Address  MGM School of Physiotherapy,1st floor C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India 
Type of Sponsor  Private medical college 
 
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 Gouri Dhumal  MGM School of Physiotherapy  Department of Musculoskeletal Physiotherapy MGM School of Physiotherapy, Room no 1, N6 CIDCO Chh Sambhajinagar,431001, Maharashtra, India
Aurangabad
MAHARASHTRA 		 7588878080

gouridhumal9909@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Guidelines Based Physiotherapy Treatment  1. Trunk muscle strengthening exercises & enduranceThe treatment include exercise targeted at trunk muscle using specific equipment together with stretching and relaxation. e.g., Glute Bridge, Bird Dog, Abdominal Crunches, Superman Position 2. Specific trunk muscle activation exercisesIsolated contractions of the target muscles (Transverse Abdominis, multifidus) for 10 repetitions of 10 seconds each while maintaining normal respiration. 3. Movement control exercisesBalance exercises were performed in the sitting, kneeling, quadruped, and supine positions. The exercises were introduced in order of increasing difficulty, tailored to the ability of each participant, and each exercise was per-formed for 2 to 3 minutes. If participants complained of even a slight increase in back pain, the exercise was interrupted and substituted with another one. 4. Trunk mobility exerciseRotation exercises were conducted in 5 different weight bearing and non-weight bearing positions including standing, sitting, supine/crook lying, side-lying (left and right) and prone. 20 5. Aerobic exerciseThese exercises were targeted to restore or enhance capacity or efficiency of cardiovascular system. This included low impact exercises like walking, cycling and steppers. Home exercise programmeIsometrics, strengthening exercises, stretching exercises two times/week when not coming to therapy sessions. Regular walking for 15 minutes and progressing to 30 minutes by end of 4th week. 
Intervention  Mind-Body Technique  The intervention was modelled on the 6-week Mindfulness-Based program. These techniques take regular activities such as sitting, walking, and lying down and transform them into meditation through directed breathing and mindful awareness of thoughts and sensations. The methods used included Pilates, body scan, sitting practice, walking meditation, and mindful stretching. Each session included time for mindfulness meditation and time for discussion of the themes brought up during the 6-week program. Pilates - In total there will be 18 sessions, thrice a week for 6 weeks. Pilates training will be provided by the therapist. Each session will be 50 minutes long including 10 minutes of warm up exercises, 20 minutes of pilates exercises, 10 minutes of cool down exercises. 17 Warm up exercises – 1. Ankle bending x 10 repetitions 2. Ankle rotation x 10 repetitions 3. Knee bending x 10 repetitions 4. Knee rotations x 10 repetitions 5. Wrist rotations x 10 repetitions 6. Elbow bending x 10 repetitions 7. Shoulder rotation in clockwise and anticlockwise x 10 repetitions 8. Neck movements (flexion, extension, side flexion, rotations) x 10 repetitions each plane 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Pain duration of at least 3 months with an average intensity of at least 3/10 (with 0 being “no
pain” and 10 “the worst pain possible”)
2. Age between 18 and 50 years.
3. Both male and female.
4. Patients complaining of sleep disturbance.
5. Patients having score 4 on Pittsburgh sleep quality scale 
 
ExclusionCriteria 
Details  1. Pain of the lower back stemming from degenerative disk disease, spinal stenosis, or muscular
or ligamentous strain
2. Past or current psychotic disorders. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pittsburgh Sleep Quality Index (PSQI)  Baseline and six weeks post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
2. NUMERICAL PAIN RATING SCALE
3. WHO Quality of Life Scale-Brief 		 Baseline and six weeks post treatment 
 
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)   28/12/2024 
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 - NO
Brief Summary   AIM: To study the effect of mind-body technique on sleep, pain and quality of life in non-specific chronic low back pain
PRIMARARY OBJECTIVE: 1.To study the effect of Mind-Body Technique on sleep in NSCLBP patient. 2.To study the effect of Mind-Body Technique on pain of NSCLBP patient. 
SECONDARY OBJECTIVE: 1.To study the effect of Mind-Body Technique on quality of life of NSCLBP patient
 
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