| CTRI Number |
CTRI/2025/03/081656 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to assess the effectiveness of fascial release technique versus conventional therapy on pain and muscle pattern at neck and shoulder joint in subjects with upper trapezius pain– a comparative study. |
|
Scientific Title of Study
|
A study to assess the effectiveness of myofascial release technique versus conventional therapy on pain and muscle recruitment pattern at scapulothoracic and glenohumeral joint in subjects with upper trapezius pain – a comparative 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 Heena Shaikh |
| Designation |
PG Student |
| Affiliation |
RV College of physiotherapy |
| Address |
RV College of physiotherapy
Department of musculoskeletal physiotherapy room no 03
Bangalore KARNATAKA 560011 India |
| Phone |
7021298228 |
| Fax |
|
| Email |
hs84240@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Archana P |
| Designation |
Associate Professor |
| Affiliation |
RV College of physiotherapy |
| Address |
RV College of physiotherapy
Department of musculoskeletal physiotherapy room no 03
Bangalore KARNATAKA 560011 India |
| Phone |
8095347575 |
| Fax |
|
| Email |
archanap.rvcp@rvei.edu.in |
|
Details of Contact Person Public Query
|
| Name |
DR Archana P |
| Designation |
Associate Professor |
| Affiliation |
RV COLLEGE OF PHYSIOTHERAPY |
| Address |
RV College of physiotherapy
department of musculoskeletal physiotherapy room no 03
Bangalore KARNATAKA 560011 India |
| Phone |
8095347575 |
| Fax |
|
| Email |
archanap.rvcp@rvei.edu.in |
|
|
Source of Monetary or Material Support
|
| RV COLLEGE OF PHYSIOTHERAPY
Musculoskeletal department
Room no 03
11th main rd 4th T Block
Jayanagar Bengaluru 560011 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 |
| DR ARCHANA P |
RV College of physiotherapy |
RV College of physiotherapy
department of musculoskeletal physiotherapy room no 03 Bangalore KARNATAKA |
8095347575
archanap.rvcp@rvei.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RV INSTITUTION ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy treatment. |
Transcutaneous electrical nerve stimulation (TENS) will be given to subjects adjuvant to exercise
rehabilitation.
TENS with frequency of 80Hz to 100Hz will be given with electrodes placed over
the trapezius muscle in a linear pattern for 10 minutes in each session.
TENS intensity will be according to Subjects tolerance.
Exercise rehabilitation will include isometric exercises and strengthening exercises
along with stretching
dosage: 10 repetitions for 3 sets.
This procedure will be repeated 4 days a week for 4 weeks.
The conventional exercise rehabilitation program is explained in the below tables. |
| Intervention |
MYOFASCIAL RELEASE |
Myofascial release technique will be applied over all the muscles mentioned in each session.
Each session will last 25-30 minutes.
Myofascial release technique will be applied by thumb after thumb, ulnar border of the hand and
forearm glide methods.
Myofascial release technique will be followed by cryotherapy to reduce the chances of soreness.
This procedure will be repeated 4 days a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate and sign the written informed consent
Age between 18 to 40 years
Subjects with a BMI less than that of 30.0 kg m2 obese category
Myofascial trigger points present on examination of the upper trapezius |
|
| ExclusionCriteria |
| Details |
Subjects having history of fracture at the cervical Spine
Subjects having any pathology at the cervical spine
Any neurological and metabolic deficits
shoulder pathologies
Mentally compromised subjects who may not comprehend the command of the physiotherapist |
|
|
Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Surface EMG
Pressure Algometer |
pre and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
12/03/2025 |
| 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="0" Months="6" 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
|
Upper
trapezius (UT) pain is a stress pain and most common type of musculoskeletal
pain in clinical practice. As the upper trapezius is a postural muscle it is
exceedingly susceptible to overuse.
Neck
pain is most frequent in middle-aged women and fluctuates with a mean
prevalence of 13%. It often affects the upper trapezius muscle. Mechanical
pain in the neck affects 30-50% of the global population during their
lifespan.
Neck
and Shoulder Musculoskeletal disorders develop due to repetitive monotonous job
profile, restricted static postures, desk/study/writing habits, or a
combination of all these factors.
Clinical
symptoms include tenderness, stiffness at the neck-shoulder complex and
occipital heaviness/headache. UT pain hampers the cervical range of motion to a
great extent.
UT
pain and MTrPs not
only alter the movement at the Scapulothoracic joint but also at
the Glenohumeral joint. The
UT is responsible for the upward rotation of the Scapula along with other
muscles that include – Lower Trapezius (LT) and Serratus Anterior
(SA). At the Glenohumeral Joint, when
abduction is carried out above 30 degrees , UT, LT, and SA must act as a group
to produce upward rotation of scapula around the Scapulothoracic joint’s center of
motion. This aids in shoulder abduction at the Glenohumeral joint and enhances
functional stability. Myofascial
Trigger Points (MTrPs) are
commonly associated with UT pain. MTrPs are hyperirritable focuses
situated inside a rigid band (Taut Band) of skeletal muscle that causes pain,
tenderness and often some anatomical changes. Myofascial
release (MFR) technique is opted for treating trapezius trigger points. It acts
by loosening up the contracted muscle and works on the blood circulation and it
also has an effect on the lymphatic drainage.
MFR
also works by producing changes in the viscoelastic properties of connective
tissue and muscle alignment restoration.
MFR
is considered to as a treatment option to reduce MTrPs
and can be applied over the UT by techniques such as thumb after thumb or by
the ulnar border of the hand. Electromyography
(EMG) can be a valuable instrument for the physiotherapist to get data about
the timing or magnitude of muscle action while examining muscle action and
pattern. Depending on the receiving electrodes EMG are of 2 types : a- Needle
Electromyography (NEMG) and b- Surface Electromyography (SEMG).
SEMG
technique works with bulk electrical conductivity principle and therefore it
eliminates the effect of the distance of the electrode placement from the
source of signal. This gives an upside to use surface electrodes on the skin
and avoid the discomfort of the procedure being invasive.
SEMG
detects and documents the electrical potential created by either neural or
electrical stimulation and give the results regarding muscular
contraction, muscular tone and muscle fatigue, activation and coordination
patterns.
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