| CTRI Number |
CTRI/2024/09/074096 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of a combination of therapeutic ultrasound with soft tissue mobilization and therapeutic ultrasound with static stretching. |
|
Scientific Title of Study
|
To Compare The Efficacy of A Combination of Therapeutic Ultrasound With Soft Tissue Mobilization And Therapeutic Ultrasound With Static Stretching on Active Trigger Points of Upper Fibers of Trapezius |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Arora |
| Designation |
Post graduate student |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical And Allied Health Sciences , |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement
Shri Guru Ram Rai University, school of paramedical and allied health sciences.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8630287030 |
| Fax |
|
| Email |
shaliniarora1307@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anirban Patra PT |
| Designation |
Associate Professor |
| Affiliation |
Shri Guru Rsm Rai Univesity, school of paramedical and health sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block , Basement
Shri Guru Ram Rai University, school of paramedical and allied health sciences.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8126657833 |
| Fax |
|
| Email |
anirbanpatra17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Arora |
| Designation |
Post graduate student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Science |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block , Basement
Shri Guru Ram Rai University, school of paramedical and allied health sciences.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8630287030 |
| Fax |
|
| Email |
shaliniarora1307@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Mahant Indresh Hospital Department of Physiotherapy North
Block , Basement
Dehradun
UTTARANCHAL
248001
India |
|
|
Primary Sponsor
|
| Name |
Shalini Arora |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North
Block , Basement
Dehradun
UTTARANCHAL
248001
India |
| 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 Anirban patra |
Shri Mahant Indiresh Hospital |
Department of Physiotherapy, North Block Basement, Shri Mahant Indiresh Hospital, Dehradun
Dehradun
UTTARANCHAL |
8126657833
anirbanpatra17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Myofascial
Trigger points |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Therapeutic ultrasound with soft tissue mobilization. |
These patients is first treated with therapeutic ultrasound (continuous) with the dosage of1.5W/cm2 , 3 MHz for 8 minutes at the trigger point or the taut band of upper fibers of trapezius and at the referred pain area.Then the patient is positioned in prone lying with head turned towards uninvolved
side and the identified restrictions is treated with soft tissue mobilization utilizing a combination of effleurage and kneading to trapezius myofascia for 10 minutes starting with 10 seconds of effleurage then 20 seconds of kneading and then both alternating for 30 seconds each, ending with effleurage). |
| Intervention |
Therapeutic ultrasound with static stretching |
These patients is treated with ultrasound (continuous) with the dosage of 1.5W/cm2, 3 MHz for 6 minutes at the trigger point or the taut band of upper fibers of trapezius followed by passive stretching of trapezius upper fibers. The end position is maintained for 30 seconds and the procedure was repeated 4 times with a rest period of 15 seconds between two stretch cycles. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Clinically active, palpable trigger point on side of the upper trapezius muscle.
Taut bant present on upper trapezius muscle.
Atypical pattern of referred pain in the ipsilateral, postero-lateral cervical spine, mastoid or temporal area |
|
| ExclusionCriteria |
| Details |
1.Having myofascial trigger point injections or receiving physical medicine in the year.
preceding this study.
2. Having a history of acute trauma.
3. Having a history of inflammatory joint or muscle disease, infection, or malignancy.
4. Having an evidence of neurologic defic |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Craniovertebral angle for Assessing Range of motion for cervical spine and Numerical Pain Rating Scale for assessing pain |
1st week, 3rd week, 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck disability index for Assessing for quality of life |
1st week, 3rd week & 6th week |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
24/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="10" |
|
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
|
Myofascial trigger point is a hyperirritable spot, usually within a taut band of skeletal muscle or in the muscle’s fascia, which is painful on compression and can give rise to characteristic referred pain, tenderness and autonomic phenomena. It includes active, latent, primary, associated, satellite and secondary. Trigger points can arise from multiple causes. Muscles become vulnerable when they are under acute or chronic stress. To compare the study on the efficacy of a combination of therapeutic ultrasound with soft tissue mobilization and therapeutic ultrasound with static stretching on active trigger point of upper fibers of trapezius. To find out the whether soft tissue mobilization is more effective than static stretching is to relieve pain and tightness of the involved muscles. |