| CTRI Number |
CTRI/2023/11/059914 [Registered on: 16/11/2023] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| 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
|
Ultrasound therapy effectiveness in upper back pain |
|
Scientific Title of Study
|
effectiveness of therapeutic ultrasound therapy among patients who suffer from thoracic back discomfort. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kumari Hritika |
| Designation |
student |
| Affiliation |
Indira Gandhi Institue of Medical Sciences |
| Address |
Department of physiotherapy, Indira gandhi institue of medical sciences, sheikhpura, Patna, Bihar
Patna
BIHAR
800014
India |
| Phone |
8409881934 |
| Fax |
|
| Email |
k.hritika19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Binay kumar pandey |
| Designation |
HOD, department of physiotherapy |
| Affiliation |
Indira Gandhi Institue of Medical Sciences |
| Address |
Department of physiotherapy, room no. 105, Indira gandhi institue of medical sciences, sheikhpura, Patna, Bihar
Patna
BIHAR
800014
India |
| Phone |
9334408377 |
| Fax |
|
| Email |
physiobinaypandey@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kumari Hritika |
| Designation |
student |
| Affiliation |
Indira Gandhi Institue of Medical Sciences |
| Address |
Department of physiotherapy, Indira gandhi institue of medical sciences, sheikhpura, Patna, Bihar
Patna
BIHAR
800014
India |
| Phone |
8409881934 |
| Fax |
|
| Email |
k.hritika19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institue Of Medical Science, sheikhpura, Patna, Bihar |
|
|
Primary Sponsor
|
| Name |
kumari Hritika |
| Address |
Department of physiotherapy, Indira gandhi institue of medical sciences, sheikhpura, Patna, Bihar |
| 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 |
| Kumari Hritika |
Indira Gandhi Institute of Medical Sciences |
Department of Physiotherapy, room no. 105, IGIMS, sheikhpura, Patna, Bihar
Patna
BIHAR |
8409881934
k.hritika19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Exercise therapy |
Exercise therapy to the control group which will be individualized as per the patients need and will include stretching exercises, strengthening exercises, and posture care for 15 days for each patient. |
| Intervention |
Ultrasound |
The dosimetry of the ultrasound will be advised after detail assessment of the site, depth and the condition of the patient. Treatment duration will be 15 days for each patient after assessing the patient before and after the treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
patients experiencing thoracic back discomfort.
patient wiling to continue the treatment. |
|
| ExclusionCriteria |
| Details |
patients with pre-existing medical conditions affecting the back, conditions contraindicating to ultrasound treatment, patient not willing to continue the treatment, severe musculoskeletal deformity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS scale |
every 2 weeks from beginning of intervention for six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswetry disability index |
every 2 weeks from beginning of intervention for six months |
| physical activity scale |
every two weeks from beginning of intervention for six months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/11/2023 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Thoracic back discomfort, also known as upper back pain, is a common issue. The sedentary lifestyles, spending long hours doing work and sitting in front of computers, can contribute to the development of musculoskeletal issues. among this thoracic back pain is one of the commonest and prevalent complaint impacting both physical and psychological well-being.The study aims to assess the effectiveness of ultrasound therapy among patients suffering from upper back pain. |