| CTRI Number |
CTRI/2025/04/084722 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Study the effect of spinal manipulation on biopsychosocial health aspects in forward shoulder posture |
|
Scientific Title of Study
|
Study the effect of spinal manipulation on biopsychosocial health aspects in forward shoulder posture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHISH TYAGI |
| Designation |
JUNIOR PHYSIOTHERAPIST |
| Affiliation |
AIIMS , NEW DELHI |
| Address |
PHYSIOTHERAPY DEPARTMENT JPNATC,AIIMS ,NEW DELHI
New Delhi
DELHI
11029
India |
| Phone |
7015473196 |
| Fax |
|
| Email |
bkashutyagi08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. AS Moorthy |
| Designation |
PHYSIOTHERAPIST |
| Affiliation |
AIIMS , NEW DELHI |
| Address |
PHYSIOTHERAPY DEPARTMENT Burns and Plastic Surgery, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9711713316 |
| Fax |
|
| Email |
aiimsmoorthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASHISH TYAGI |
| Designation |
JUNIOR PHYSIOTHERAPIST |
| Affiliation |
AIIMS , NEW DELHI |
| Address |
PHYSIOTHERAPY DEPARTMENT JPNATC,AIIMS ,NEW DELHI
DELHI
11029
India |
| Phone |
7015473196 |
| Fax |
|
| Email |
bkashutyagi08@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
AIIMS NEW DELHI 110029 |
| Type of Sponsor |
Research institution |
|
|
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 Ashish Tyagi |
physiotherapy department Room No. 152 JPNATC AIIMS |
JPNATC, AIIMS, RAJ NAGAR, New Delhi, Delhi 110029
New Delhi
DELHI |
7015473196
bkashutyagi08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy Treatmnt for forward shoulder posture |
Stretching, strengthing exercise, mobilization & home exercise programme |
| Intervention |
Spinial manipulation & Conventional physiotherapy |
Spinal manipulation is a therapeutic intervention commonly used in physiotherapy/chiropractic care to address musculoskeletal issues, particularly those related to the spine. It involves the application of controlled force to a joint, aiming to improve spinal motion and alleviate discomfort. frequency of session on alternate days three times a week for a duration of 4 weeks |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Presence of Neck Pain Both groups must report neck pain for at least 3 months chronic with a pain intensity of greater than 3 by 10 on the Visual Analog Scale
Neck Pain with Forward Shoulder Posture Diagnosed with Forward Shoulder Posture using photogrammetry or clinical methods eg shoulder angle greater than 25° deviation from the vertical axis
Activity Level Sedentary to moderately active individuals to control for activity level as a confounding factor
General Health Participants must be otherwise healthy with no systemic diseases affecting musculoskeletal or nervous systems
BMI Range: Normal or overweight individuals BMI between 18 & 5 and 30 kg by m² to minimize variability due to extreme body compositions
Consent Willingness to participate and provide informed consent after understanding the studys procedures |
|
| ExclusionCriteria |
| Details |
History of Major Spinal Injury or Surgery Individuals with a history of spinal surgery significant spinal injury or severe musculoskeletal abnormalities are excluded to avoid confounding factors and ensure safety during spinal manipulation
Pregnancy Pregnant individuals are excluded as pregnancy related changes in posture respiratory function and ANS balance may introduce variability in the results and could increase risks associated with spinal manipulation
Chronic Pain Conditions or Severe Psychological Disorders Participants with chronic pain conditions eg fibromyalgia or severe mental health disorders are excluded as these conditions can affect psychosocial outcomes and pain perception making it difficult to isolate the effects of spinal manipulation on FSP
Use of Medications Affecting the Autonomic Nervous System Participants currently taking medications that influence the ANS such as beta blockers are excluded to avoid pharmacological interference with the ANS measurements.
No Recent History of Spinal Manipulation or Postural Therapy Participants should not have undergone spinal manipulation physical therapy or other postural interventions in the last six months This criterion is to ensure baseline comparability and to eliminate the effects of previous interventions on the study outcomes
Acute Neck Pain Participants with acute or recent neck pain smaller than 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
heart rate variabilty (ANS Function)
Pulomoary function
Posture |
T1 before starting treatment
T2 after 4 weeks of starting treatment
T3 after 8 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life
Stress |
T1 before starting treatment
T2 after 4 weeks of starting treatment
T3 after 8 weeks of treatment |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/02/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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
Modification(s)
|
This study aims to evaluate the impact of spinal manipulation on biopsychosocial health factors in individuals with forward shoulder posture. The primary objective is to assess improvements in physical aspects such as posture and pain, while also examining psychological factors like anxiety and depression, and social aspects like daily functioning and quality of life. Participants will undergo spinal manipulation therapy over a period of four weeks, with outcomes measured before and after treatment using objective and subjective assessments. The findings of this study could provide insights into the holistic benefits of spinal manipulation in addressing both musculoskeletal and psychosocial aspects of forward shoulder posture. |