| CTRI Number |
CTRI/2025/03/082385 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative between Fascial Distortion Model and Counterstrain technique and their impact on Pain, Mobility, and Function in Badminton Players with Trigger Points |
|
Scientific Title of Study
|
Effectiveness of Fascial Distortion Model Approach versus Counterstrain Technique on Trigger Points Pain Pressure Threshold, Range of Motion and Functional activities in Recreational Badminton Players: 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 |
Ayushi Gupta |
| Designation |
PG Student |
| Affiliation |
PG Student |
| Address |
SGT University, Chandu Budhera, Gurgaon, Haryana
Gurgaon HARYANA 122505 India |
| Phone |
8743995475 |
| Fax |
|
| Email |
ayushi2000.gupta@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pooja Anand |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
SGT University, Chandu Budhera, Gurgaon, Haryana
Gurgaon HARYANA 122505 India |
| Phone |
9599810884 |
| Fax |
|
| Email |
pooja.physiotherapy@sgtuniversity.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Pooja Anand |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
SGT University, Chandu Budhera, Gurgaon, Haryana
Gurgaon HARYANA 122505 India |
| Phone |
9599810884 |
| Fax |
|
| Email |
pooja.physiotherapy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, SGT University Chandu Budhera 122505 |
|
|
Primary Sponsor
|
| Name |
Ayushi Gupta |
| Address |
SGT University, Chandu Budhera, 122505 |
| 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 |
| Ayushi Gupta |
SGT Medical college |
Physiotherapy OPD, Room no.13 Gurgaon HARYANA |
08743995475
ayushi2000.gupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethical Committee, Faculty of Physiotherapy, SGT University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Counterstrain Technique |
the Counterstrain Technique refers to the manual positioning of the body by trained practitioners to alleviate strain on identified trigger points.
3 sessions per week for 4 weeks protocol. |
| Intervention |
Fascial Distortion Model |
the FDM approach refers to the application of manual therapy techniques by trained practitioners to identify and address areas of fascial distortion.
3 sessions per week for 4 weeks protocol. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
48.00 Year(s) |
| Gender |
Both |
| Details |
Participants must engage in badminton as a recreational activity for at least 2 times per week in 1 years
Participants should exhibit trigger points in upper back muscle group who reported trigger point pain upon palpation
Player elicits Positive jump sign
Trigger point palpation pain assessed with Visual Analogue Scale (VAS) is above 3.
|
|
| ExclusionCriteria |
| Details |
Any chronic medical conditions such as Diabetes Mellitus, Hypertension, Asthma, COPD, Osteoarthritis, CKD etc
Any recent acute injuries, such as Ankle Sprain, Fractured Bone, Concussion, Dislocated Joint, Burns, Lacerations
Any musculoskeletal disorder or postural abnormalities like Forward head posture or upper cross syndrome
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity, Pain Pressure Threshold |
Day 1 of assessment
4th week of assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion and DASH Questionnaire |
Day 1 assessment
4th week assessment |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
28/03/2025 |
| 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="1" Months="0" Days="0" |
|
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 are classified as being active or latent, depending on
their clinical characteristics. An active trigger point causes pain at rest. It
is tender to palpation with a referred pain pattern that is similar to the
patient’s pain complaint. This referred pain is felt not at the site of the
trigger-point origin, but remote from it. The pain is often described as
spreading or radiating. Referred pain is an important characteristic of a
trigger point. It differentiates a trigger point from a tender point, which is
associated with pain at the site of palpation only. shortening
tissues may affect local cellular healing adaptations. The pathophysiology of MTrPs is not fully understood,
but current hypotheses suggest that they arise from a combination of
mechanical, neurological, and biochemical factors. Muscle overload, repetitive
strain, poor posture, and stress are all considered potential contributors to
the formation of trigger points. In response to these stressors, localized
areas of muscle may undergo a state of sustained contraction, leading to the
development of taut bands and the subsequent formation of trigger points. These
points, when compressed or stressed, can produce local and referred pain,
contributing to a wide range of chronic pain conditions, including tension
headaches, neck pain, and back pain. This study seeks
to address the gap by conducting a comparative investigation into the
effectiveness of the FDM approach versus Counterstrain Technique in managing trigger
points pain pressure threshold, ROM, and functional performance among
recreational badminton players.
H (0): There will be no significant difference in the effect of
the Fascial Distortion Model approach on trigger
points pain pressure threshold, range of motion and functional activities in recreational
badminton players.
H
(0): There will be no significant difference in
the effect of the Counterstrain technique on trigger points pain
pressure threshold, range of motion and functional activities in recreational
badminton players.
H
(0): There will be no significant difference in
the effect of the Fascial Distortion Model and counterstarin technique on
trigger points pain pressure threshold, range of motion and functional
activities in recreational badminton players.
H (1):
There will be significant difference in the
effect of the Fascial Distortion Model approach on trigger points pain
pressure threshold, range of motion and functional activities in recreational
badminton players.
H (2): There will be
significant difference in the effect of the Counterstrain technique on trigger points pain pressure threshold, range of
motion and functional activities in recreational badminton players.
H (3): There will be
significant difference in the effect of the Fascial Distortion Model and
counterstarin technique on trigger points
pain pressure threshold, range of motion and functional activities in
recreational badminton players.
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