| CTRI Number |
CTRI/2025/02/079903 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
ENHANCING PAIN RELIEF AND MOBILITY BOWEN TECHNIQUE WITH HOT PACKS FOR TRAPEZITIS |
|
Scientific Title of Study
|
SHORT TERM EFFECTS OF BOWEN TECHNIQUE WITH HOT PACKS ON PAIN CERVICAL RANGE OF MOTION IN TRAPEZIUS MYOFASCIAL TRIGGER POINTS A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| raviraj09199@gmail.com |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARINI BIIDARI |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NUMBER 5 ORTHO PHYSIOTHERAPY DEPARTMENT SDM COLLEGE OF PHYSIOTHERAPY,SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL
MANJUSHREE NAGAR SATTUR
DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
9483667354 |
| Fax |
|
| Email |
bidariharini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HARINI BIIDARI |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NUMBER 5 ORTHO PHYSIOTHERAPY DEPARTMENT SDM COLLEGE OF PHYSIOTHERAPY,SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL
MANJUSHREE NAGAR SATTUR
DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
9483667354 |
| Fax |
|
| Email |
bidariharini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAVI SAVDATTI |
| Designation |
PROFESSOR AND PG GUIDE SDM COLLEGE OF PHYSIOTHERAPY |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NUMBER 5 ORTHO PHYSIOTHERAPY DEPARTMENT SDM COLLEGE OF PHYSIOTHERAPY,SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL
MANJUSHREE NAGAR SATTUR DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
9606528129 |
| Fax |
|
| Email |
raviraj09199@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL SDM COLLEGE PF PHYSIOTHERAPY MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA 580009 |
|
|
Primary Sponsor
|
| Name |
HARINI BIDARI |
| Address |
SDM COLLEGE OF PHYSIOTHERAPY SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD 580009 |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Harini Bidari |
SDM MEDICAL COLLEGE AND HOSPITAL |
opd number 5 ortho physiotherapy department SDM College of
Physiotherapy, SDM University
Dharwad
KARNATAKA |
9483667354
bidariharini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of medical science and hospital institutional ethics committe. |
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 |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Randomised controlled trial. |
BOWEN TECHNIQUE
Patient position: - prone lying (affected area to be exposed)
Technique: - fingers are used to apply gentle pressure and,
rolling movements on the affected side of the muscle for
thirty seconds.
Treatment time: - 15-20 minutes,3-4 repetitions The
skin is stretched and moved with every rolling
movement.
The movements will be repeated every two minutes at rest
intervals as necessary.
Intervention protocol for Group B
thermotherapy
patient position: -prone lying
(light loose clothing)
Technique: -A hot pack wrapped in a towel is applied
over the affected area of the muscle. Treatment time: -10-
15 minutes
(patient is continuously monitored)
DOSAGE
Three treatment sessions will be given for a week in the
physiotherapy outpatient department.
Pre and post assessment will be assessed after one week of |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
diagnosis of neck pain less than three months with myofascial trigger point in trapezius
pain ranging from four to ten on NPRS
agreement to participate in the study |
|
| ExclusionCriteria |
| Details |
1.skin allergies/disease.
2. cervical radiculopathy.
3. surgeries in and around neck and shoulder in past 6 months.
4. history of previous neck or shoulder trauma.
5. acute torticollis, cancer, infection, fracture of cervical and thoracic
vertebrae.
6. sensory alterations in neck and upper back region. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Numerical pain rating scale.
2.pain pressure threshold.
3. Neck disability index.
4. Cervical range of motion. |
Three days a week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain pressure threshold. |
Three days a week. |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
20/02/2025 |
| 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
|
|
Brief Summary
|
ed, Two groups Group A(BOWEN TECHNIQUE) and Group B (THERMOTHERAPY) Sample size (38) will be included as per inclusion and exclusion criteria. BOWEN TECHNIQUE Patient position: - prone lying (affected area to be exposed) Technique: - fingers are used to apply gentle pressure and, rolling movements on the affected side of the muscle for thirty seconds. Treatment time: - 15-20 minutes,3-4 repetitions The skin is stretched and moved with every rolling movement. The movements will be repeated every two minutes at rest intervals as necessary. Intervention protocol for Group B thermotherapy patient position: -prone lying (light loose clothing) Technique: -A hot pack wrapped in a towel is applied over the affected area of the muscle. Treatment time: -10- 15 minutes (patient is continuously monitored) DOSAGE Three treatment sessions will be given for a week in the physiotherapy outpatient department. Pre and post assessment will be assessed after one week of |