| CTRI Number |
CTRI/2025/01/079360 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| 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
|
To find the Effect of Fascial Stretching and Proprioceptive Neuromuscular Facilitation Stretching Techniques on Muscle Soreness in young individuals |
|
Scientific Title of Study
|
Effect of Fascial and Proprioceptive Neuromuscular Facilitation Stretching Techniques on Delayed Onset Muscle Soreness in Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/NEW/IND/2021/1807 |
NIL |
| ECR/358/Indt/DL/2022 |
NIL |
| IORG0011725 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheenu |
| Designation |
Student |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University, Department of Physiotherapy, Neurology department, Neurology Lab room no- 421, Sohna road, Gurugram, Haryana
Gurgaon
HARYANA
122103
India |
| Phone |
8826635319 |
| Fax |
|
| Email |
bajwansheenu25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Kumar |
| Designation |
Associate Professor |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University, Department of Physiotherapy, Neurology department, Neurology Lab room no- 412, Sohna road, Gurugram, Haryana
Gurgaon
HARYANA
122103
India |
| Phone |
9582553124 |
| Fax |
|
| Email |
mkumar.physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwajeet Trivedi |
| Designation |
Associate Professor |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University, Department of Physiotherapy, Neurology department, Neurology Lab room no- 412, Sohna road, Gurugram, Haryana
HARYANA
122103
India |
| Phone |
9779046672 |
| Fax |
|
| Email |
physiovishu87@gmail.com |
|
|
Source of Monetary or Material Support
|
| GD Goenka University, Sohna, Gurugram, Haryana, India- 122103 |
|
|
Primary Sponsor
|
| Name |
sheenu |
| Address |
GD Goenka University, Sohna road, Gurugram, Haryana, India- 122103
|
| 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 Sheenu |
GD Goenka University |
GD Goenka University, Department of Physiotherapy, Neurology department, Neurology Lab room no- 421,
Sohna road, Gurugram, Haryana
Gurgaon
HARYANA |
8826635319
bajwansheenu25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Waves Women Empowerment Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Delayed Onset Muscle Soreness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascial Stretching Technique |
Fascial Stretching Technique will include Deep Frontal Arm Line stretching for shoulder extension/internal rotation and elbow extension. the technique will be for shoulder traction in transverse, horizontal abduction to target bicep brachii. The FST session for each individual will be of 30 minutes. |
| Comparator Agent |
Passive rest |
participant will be asked to sit on a chair in a well-lit, quiet room with normal temperature and refrain from talking or doing any activity for 30 minutes |
| Comparator Agent |
Proprioceptive Neuromuscular Facilitation Stretching Technique |
Proprioceptive Neuromuscular Facilitation Stretching Technique of Hold Relax with Agonist Contraction Technique for bicep brachii in 5 sets with resistance provided for 7 seconds with 30 sec rest periods and 2-3 min interval between each set. The total PNF stretching session will be for 30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
18- 30 Years of Age, Both Male & Female, Moderately Active adults – International Physical Activity Questionnaire
|
|
| ExclusionCriteria |
| Details |
Any upper limb or lower limb injury, Chronic conditions affecting physical activity like any orthopedics, cardiovascular, neurological, endocrine, or psychiatric diseases. Participation in Fascial Stretching Programs, PNF stretching program and Use of NSAIDs or analgesics in the week before or on the days of experiment. participant has indulged in any aerobic or anaerobic exercise 24 hour before participation.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale, Range of motion |
Pre-intervention, post intervention at 24hrs, 48hrs,72hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain pressure threshold |
Pre-intervention, post intervention at 24hrs, 48hrs,72hrs |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
27/01/2025 |
| 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="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
|
This study will involve 33 participants will perform an eccentric exercise of elbow flexion with 80%of their 1RM weight to induce delayed onset muscle soreness. The three groups will receive their treatment for Fascial Stretching Technique (Group 1), Proprioceptive Neuromuscular Facilitation Stretching Technique (Group 2), and passive rest (Group 3). Pre- intervention assessment will be done prior to the application of the treatment and post-intervention assessments will be done after the treatment at 24 hours’, 48 hours’ and 72 hours’. Interventions: - Group 1: Fascial Stretching Technique that will include Deep Frontal Arm Line stretching for shoulder extension/internal rotation and elbow extension. The other technique will be for shoulder traction in transverse, horizontal abduction to target bicep brachii.
- Group 2: Proprioceptive Neuromuscular Facilitation Stretching Technique of Hold Relax with Agonist Contraction Technique for bicep brachii in 5 sets with resistance provided for 7 seconds with 30 sec rest periods and 2-3 min interval between each set.
- Group 3: Passive rest will be given to this group, the participants will be asked to sit on a chair in a well-lit, quiet room with normal temperature and refrain from talking or doing any activity.
Assessment and Analysis: The pre-intervention baseline data of the dependent variables consisting of ROM, VAS, PPT will be taken. First reading will be taken prior to the treatment. Post-intervention; second reading will be taken post-intervention at 24 hours; third reading at 48 hours; and fourth at 72 hours’. |