| CTRI Number |
CTRI/2025/08/093729 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Link Between Back Muscle Tightness and Opposite Side Hip Muscle Strength in People with Long-Term Low Back Pain |
|
Scientific Title of Study
|
Correlation between latissimus dorsi muscle length and contralateral gluteus maximus muscle strength in patients with chronic mechanical low back pain: A cross-sectional 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 |
PALAK BUNDELA |
| Designation |
Post graduate student |
| Affiliation |
Shree Bharatimaiya College of Optometry and Physiotherapy |
| Address |
Opp. Swaminarayan Temple, Unai Road, Vyara, Di. Tapi Opp. Swaminarayan Temple, Unai Road, Vyara, Di. Tapi
Surat GUJARAT 394650 India |
| Phone |
08238733490 |
| Fax |
|
| Email |
bundelapalak22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sapna Chaudhary |
| Designation |
Assistant Professor |
| Affiliation |
Shree Bharatimaiya College of Optometry and Physiotherapy |
| Address |
Shree Bharatimaiya College of Optometry and physiotherapy Vesu Main Road Behind Big Bazar Street Vrudhashram Piplod, Surat Gujarat · Surat GUJARAT 395007 India |
| Phone |
09714750652 |
| Fax |
|
| Email |
sapnakumari.112343@marwadiuniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Sapna Chaudhary |
| Designation |
Assistant Professor |
| Affiliation |
Shree Bharatimaiya College of Optometry and Physiotherapy |
| Address |
Shree Bharatimaiya College of Optometry and physiotherapy Vesu Main Road Behind Big Bazar Street Vrudhashram Piplod, Surat Gujarat ·
GUJARAT 395007 India |
| Phone |
09714750652 |
| Fax |
|
| Email |
sapnakumari.112343@marwadiuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Shree Bharatimaiya college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
PALAK BUNDELA |
| Address |
Opp. Swaminarayan Temple, Unai Road, Vyara, Di. Tapi
Vesu Main Road, Street Vrudhashram, behind Big Bazar, Piplod, Surat, Gujarat 395007 |
| 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 |
| Dr PALAK BUNDELA |
Shree Ambikaniketan trust sanchalit physiotherapy clinic |
Physiotherapy OPD, near Ambikaniketan Vrudhasram, Vesu, 395007. Surat GUJARAT |
08238733490
bundelapalak22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Shree Bharatimaiya College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants aged between 24 to 55, both male and female.
2. Mechanical low back pain for more than 3 months.
3. Participants who have not received physiotherapy treatment for more than 1 week before
participation.
4. Participants who have a pain score more than 3 on the Numerical Pain Rating Scale (NPRS). |
|
| ExclusionCriteria |
| Details |
1. Lumbar radiculopathy or any spinal cord injury.
2. Spinal deformities (e.g., scoliosis, spondylolisthesis) and lower extremity deformities.
3. Hip joint pathology (e.g., osteoarthritis, labral tear, femoroacetabular impingement) or hip
flexion contracture.
4. Sacroiliac (SI) joint dysfunction
5. Shoulder conditions (e.g., rotator cuff tear, adhesive capsulitis, shoulder instability).
6. History of trauma or surgery involving the spine, hip, or shoulder.
7. Participants who have taken pain relief medications (NSAIDs, opioids, or corticosteroids)
or muscle relaxants within the last 48 to 72 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation (Spearman’s rho) between latissimus dorsi muscle length (shoulder flexion angle in degrees measured with scapula/rib cage stabilized) and contralateral gluteus maximus muscle strength (MMT grade 0–5) assessed by Manual Muscle Testing |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index |
baseline |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
10/09/2025 |
| 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 - NO
|
|
Brief Summary
|
The study, a cross-sectional study titled -Correlation between Latissimus Dorsi Muscle Length and Contralateral Gluteus Maximus Muscle Strength in Patients with Chronic Mechanical Low Back Pain. The study aims to investigate the relationship between latissimus dorsi (LD) tightness and contralateral gluteus maximus (GM) weakness in patients with chronic mechanical low back pain (CMLBP). Low back pain is one of the most common musculoskeletal problems globally, often linked to muscle imbalance, fascial dysfunction, and altered biomechanics. The thoracolumbar fascia (TLF) connects the LD and contralateral GM as part of the posterior oblique sling system, which plays a crucial role in spinal and pelvic stability. The posterior sling, which connects the latissimus dorsi muscle and the gluteus maximus muscle through the thoracolumbar fascia. Dysfunction in this system may lead to compensatory movement patterns, postural abnormalities, and persistent pain. While past studies have independently examined LD tightness and GM weakness in CMLBP, their direct correlation has not been established. This study plans to assess LD muscle length and GM strength bilaterally using standardized tests, alongside functional disability through the Modified Oswestry Low Back Pain Disability Questionnaire. Data from patients aged 24–55 years who have pain more than 3 according to the NPRS score and more than 3 months of lower back pain. The latissimus dorsi muscle tightness will be checked with the muscle length test, and the gluteus maximus muscle strength will be checked with a manual muscle test bilaterally. The results will be analyzed using appropriate statistical tests to determine whether a significant correlation exists, providing evidence for improved rehabilitation strategies that focus on both LD mobility and GM strengthening. |