| CTRI Number |
CTRI/2024/08/073160 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Craniosacral therapy] |
| Study Design |
Other |
|
Public Title of Study
|
"Can Craniosacral Therapy Help with Neck Pain After Giving Birth? A Study to Find Out" |
|
Scientific Title of Study
|
Immediate Effect of Craniosacral Therapy on Postpartum Neck 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 |
Dr Ashwini Bulbuli |
| Designation |
Associate professor, Department of OBG Physiotherapy |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Advanced physiotherapy Center, Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA
590010 India
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9916043325 |
| Fax |
|
| Email |
ashwinichougala05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Bulbuli |
| Designation |
Associate professor, Department of OBG Physiotherapy |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Advanced physiotherapy Center, Sagar Floor,
Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA
590010 India
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9916043325 |
| Fax |
|
| Email |
ashwinichougala05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sona Yanghi Hurtigkarl |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Advanced physiotherapy center,
Sagar Floor, KLE
Hospital Dr.Prabhakar Kore Hospital and MRC. Belgaum
KARNATAKA 590010 India
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
08279500757 |
| Fax |
|
| Email |
shurtigkarl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Prabhakar Kore hospital and MRC. Belgaum KARNATAKA 590010 India |
|
|
Primary Sponsor
|
| Name |
Self sponsored project |
| Address |
Self sponsored project |
| Type of Sponsor |
Other [Self sponsored project] |
|
|
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 |
| Sona Yanghi Hurtigkarl |
Dr.Prabhakar Kore hospital and MRC. |
Advanced Physiotherapy Centre OPD- 39, Sagar Ward, Dr.Prabhakar Kore hospital and MRC. Nehru Nagar, Belagavi KARNATAKA 590010 India
Belgaum
KARNATAKA |
8279500757
shurtigkarl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific and Ethics Committe, KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum neck pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Craniosacral therapy |
Prior to receiving Craniosacral therapy, postpartum neck pain is examined using a numerical pain rating scale. The examination is repeated following the procedure.
Each participant will receive a 20-minute treatment for a single session. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Postpartum women who are willing to participate.
Postpartum women suffering from neck pain.
Postpartum women between 21-40 years of age.
|
|
| ExclusionCriteria |
| Details |
Women with the history of chronic orthopaedic conditions.
Women suffering from febrile condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale (NPRS).
|
Subjective pain assessment questionnaire to measure the pain intensity the patient feels
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pressure Biofeedback Unit (Chattanooga) |
Objective pain assessment questionnaire using the NPRS scale before the craniosacral treatment and 24 hours after the craniosacral therapy to measure any difference in pain intensity or severity. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
08/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/02/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)
|
The study will involve obtaining ethical clearance, recruiting participants, collecting demographic data, and assessing postpartum women aged 21-40, hospitalized in the tertiary health care facility in Belagavi, Karnataka, will be randomly assigned to 2 clusters based on the presence or absence of neck pain symptoms. The cluster comprising women experiencing neck pain will receive craniosacral therapy, with assessments conducted before and after the therapy session. The participants will be asked to fill out the Numerical Pain Rating Scale (NPRS) and Neck Disability Index (NDI) questionnaires to measure their neck pain intensity and self-rated disability resulting from neck pain. The Pressure Biofeedback Unit will be utilized as an objective measuring tool for assessing neck movement and strength of the cervical muscles. The scores and values from the NPRS, NDI questionnaires and Pressure Biofeedback Unit will be tabulated, analyzed, and interpreted to determine the intensity, weakness and resulting disability from postpartum neck pain. Following the completion of all outcome measures, the subject will then undergo Craniosacral therapy in a quiet, peaceful, and well-ventilated room for 30 minutes. During the session, the subject will be instructed to lie supine on the bed with the head resting on a pillow and arms comfortably resting on either side of the body. The therapist will be sitting at the head end of the subject and will gently place their hands on the cranium, sub-occipital region and shoulders of the patient to offer craniosacral therapy. Following the craniosacral therapy, a follow-up assessment will be conducted 24 hours after the intervention. During this assessment, the Numerical Pain Rating Scale (NPRS), Neck Disability Index (NDI), and Pressure Biofeedback Unit measurements will be taken again. The data will then be tabulated, analyzed, and interpreted to assess any changes in the severity and disability resulting from postpartum neck pain. |