| CTRI Number |
CTRI/2025/05/086836 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Muscle Energy Technique With and Without Diaphragmatic Training in People With Lumbar functional Instability - Randomized control trial |
|
Scientific Title of Study
|
Comparative Efficacy Of Muscle Energy Technique Combined with Diaphragmatic Training Versus Muscle Energy Technique Alone In Managing Lumbar Functional Instability -A Randomized Control 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 |
Kajal jain |
| Designation |
student |
| Affiliation |
SGT university |
| Address |
Department of faculty of physiotherapy, SGT university Chandu Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
9560562192 |
| Fax |
|
| Email |
kajaljain9560@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Priyanka Rishi |
| Designation |
Associate Professor |
| Affiliation |
SGT university |
| Address |
Department of faculty of physiotherapy, SGT university Chandu Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
8588878467 |
| Fax |
|
| Email |
prnk.rishi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kajal jain |
| Designation |
student |
| Affiliation |
SGT university |
| Address |
Department of faculty of physiotherapy, SGT university Chandu Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
9560562192 |
| Fax |
|
| Email |
kajaljain9560@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of physiotherapy, SGT university Chandu Budhera village 122505 |
|
|
Primary Sponsor
|
| Name |
Kajal jain |
| Address |
Department of faculty of physiotherapy, SGT university Chandu Budhera |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kajal jain |
SGT medical college and Hospital |
Room no. 13, Physiotherapy OPD basement Floor, SGT hospital, Gurgaon, Haryana
Gurgaon
HARYANA |
9560562192
kajaljain9560@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental ethical committee faculty of physiotherapy, SGT university |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 - muscle energy technique and conventional treatment
Group 2- Muscle energy technique, Diaphragmatic technique and conventional treatment |
Patients will be divided into three groups to assess the effects of treatment on lumbar instability and respiratory function. Group 1 will receive Muscle Energy Technique (MET) and conventional physiotherapy for total 35 mins, while Group 2 will receive MET, Diaphragmatic Technique, and conventional treatment for 40 mins. Both groups will undergo therapy three times a week for four weeks. |
| Comparator Agent |
Group 3 - conventional treatment |
Patients will undergo lumbar stabilization exercises as part of conventional physiotherapy for total 20 mins to improve core strength and spinal stability. The exercises will be performed three times a week for four weeks under supervision. The intervention aims to enhance spinal control, reduce instability, and improve functional movement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Persons between 18–35 years of age and having had low back pain of more than 3 months.
2. low back without referred leg pain of at least 3 months duration.
3. Male and female both will be included.
4. Score of 3 or higher on the numeric rating scale (NRS)
5. Positive in 3 or more out of the 5 items in the lumbar instability test
6. Localized midline pain in the low back and tenderness on palpation, painful arc during spinal movements, pain on jerky movements.
7. Participants were asked not to have any other treatment during the time of the training.
8. Subjects with previous history of low back pain were also included.
|
|
| ExclusionCriteria |
| Details |
1. Diagnosed other specific causes of low back pain
2. balance problems of neurological origin
3. Respiratory diseases, cardiopulmonary diseases
4. Osteoporosis, rheumatoid arthritis
5. Previous thoracic surgery
6. Previous surgical interventions affecting the trunk or the limbs and the subjects being uncooperative.
7. The participants were asked to indicate immediately if an acute inflammatory disease occurred, had suffered from infection, inflammation,
8. Fractures, malignancies, or any kind of systematic diseases were excluded.
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Disability, Lumbar mobility (ROM), Muscle Strength of diaphragm, erector spinae and multifidus, Internal/ External Abdominal Obliques, and transversus abdominis, Quality of life |
Day 1 assessment, 4th week assessment |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| FVC, FEV1, FEV1/FVC % |
Day 1 assessment, 4th week assessment |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/05/2025 |
| 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 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 - NO
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Brief Summary
|
Lumbar instability is a key factor in chronic low back pain (CLBP), often resulting from muscle imbalances, motor dysfunction, and impaired spinal stabilization. It is commonly classified as functional, structural, or combined instability, with the neutral zone theory explaining segmental laxity as a marker of instability. Lumbar stabilization relies on three subsystems: passive (bones, discs, ligaments), active (muscles), and neural control. Core muscles, including the lumbar multifidus, transversus abdominis, pelvic floor, and diaphragm, play a vital role in maintaining spinal stability. Muscle Energy Technique (MET) is widely used to improve muscle function, reduce spasm, and restore neuromuscular coordination. The diaphragm, a key core stabilizer, works synergistically with the transversus abdominis and pelvic floor muscles, making diaphragmatic training and inspiratory muscle training (IMT) valuable in lumbar instability rehabilitation. This study aims to assess the impact of MET and diaphragmatic techniques on spinal stability and respiratory function, providing insights into optimizing treatment strategies for CLBP. Null Hypothesis 1. H0 1 - There will be no significant difference in the effect of muscle energy technique combined with diaphragmatic training versus muscle energy technique alone in managing pain and improve muscle strength of stabilizing muscle in case of lumbar functional instability. 2. H0 2 - There will be no significant difference in the effect of muscle energy technique combined with diaphragmatic training versus muscle energy technique alone in managing disability, lumbar mobility, respiratory parameters and quality of life Alternate Hypothesis 1. H0 1 - There will be significant difference in the effect of muscle energy technique combined with diaphragmatic training versus muscle energy technique alone in managing pain and improve muscle strength of stabilizing muscle in case of lumbar functional instability. 2. H0 2 There will be significant difference in the effect of muscle energy technique combined with diaphragmatic training versus muscle energy technique alone in managing disability, lumbar mobility, respiratory parameters and quality of life
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