| CTRI Number |
CTRI/2025/08/092826 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| 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
|
Effect of Neck muscle release along with Neck Exercises on joint sense, pain and strength in neck pain: A Randomized controlled trial
|
|
Scientific Title of Study
|
Effect of Myofascial release along with Neck Stability Exercise on position sense, pain and Strength in Neck Pain : Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Govind Mukesh Sharma |
| Designation |
Post Graduate student |
| Affiliation |
KLES Institute of Physiotherapy Belgaum |
| Address |
KLES DR. Prabhakar kore Hospital and MRC, Advanced Physiotherapy Centre Orthopedic Department Room 18, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9421306088 |
| Fax |
|
| Email |
gs9420979090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Govind Mukesh Sharma |
| Designation |
Post Graduate student |
| Affiliation |
KLES Institute of Physiotherapy Belgaum |
| Address |
KLES DR. Prabhakar kore Hospital and MRC, Advanced Physiotherapy Centre Orthopedic Department Room 18, Nehru Nagar, Belagavi.
KARNATAKA
590010
India |
| Phone |
9421306088 |
| Fax |
|
| Email |
gs9420979090@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarti Welling |
| Designation |
MPT (Phd) |
| Affiliation |
KLES Institute of Physiotherapy Belgaum |
| Address |
KLES DR. Prabhakar kore Hospital and MRC, Advanced Physiotherapy Centre Orthopedic Department Room 18, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwelling@klekit.edu.in |
|
|
Source of Monetary or Material Support
|
| KAHER institute of physiotherapy nehru nagar belgavi 590010 |
|
|
Primary Sponsor
|
| Name |
Govind Sharma |
| Address |
KAHER institute of physiotherapy nehru nagar belgavi 590010 |
| 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 Govind Mukesh Sharma |
KLES DR PRABHAKAR KORE HOSPITAL |
KLE Hospital Advanced Physiotherapy Centre Room 18,Orthopaedic Department, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA |
09421306088
gs9420979090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kle academy of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
neck pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
myofascial release (SEA release) |
Sequence of treatment as per segments used in myofascial release: myofascial release will be given to deltoid, supraspinatus, leavator scapulae, superior trapezius taking 1-2 min per pattern.
Therapist will apply a medium as gel/ Vaseline to treatment area, afterwards the instrument (m2t) placed on the muscle at 45° angle consecutively will be applied for muscles for about 2 to 5 mins.
Duration of treatment will be for 5 mins having 8 to 10 strokes per session. After the completion of IASTM a gentle cryotherapy will be applied for 15 mins.
Dose 8 to 12 strokes of release applied on the muscle superficially, frequency will be for around 2 week with instrument assisted soft tissue mobiliser having total duration of 25 minutes of the intervention.
|
| Comparator Agent |
Neck Stabilization Exercises |
1)Neck isometrics in supine for 15 second with 10 second breaks between for 10-15 repetitions
2)multi-directional isometric exercise (cervical flexion, extension, rotation, side flexion) in sitting high supported 15 second with 10 second breaks between for 10-15 repetitions
3)Upper extremity movement exercise
shoulder flexion, extension, abduction, adduction, internal and external rotation 2 sets for 15 repetitions
4) Resistive exercises (seated shoulder press, lateral and front arm raises, hammer curls ) with resistant band (red) as per force of elongation with moderate resistance with 2 sets of 15 repetitions
Dosage will be 2 sets 15 repetitions, frequency 5 times a week administered by qualified physiotherapist total duration of intervention will be 50 minutes
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
subjects with clinically diagnosed with non specific neck pain less then 3 months of duration
mean error more then 6cm for joint sense
negative spurling test
|
|
| ExclusionCriteria |
| Details |
specific cause: sever trauma, tumors, spinal anomalies.
diagnosed neurological diseases
subjects with skin irritation
diagnosed case of vertigo, nystagmus
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessing pain |
assessing pain using numerical pain scale assessed at baseline and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cervical kinesthesia |
using the joint sense assessment, taken at baseline and after 2 weeks |
| endurance |
cervicale muscle strength using strength test assessed at baseline and after 2 week |
| to assess reaction time and hand eye coordination |
assessment of sensorimotor assessed initial and after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 a randomized controlled trial assessing the effect of muscle release with neck stabilization group, where in one group is given the release, coventional physiotherapy with neck stabilization exercise and other group being given neck stabilization exercise along with neck stabilization exercise. here we assessed the cervcial joint sense position, pain, sensiromotor distrubances and cervcial endurance which were assessed at baseline and after 2 weeks of intervention. the release included the muscle released being trapezius, supraspinatus, medial deltoids and leavator scapulae. neck stabilization intervention included neck isometrics, multidirectional isometric exercise, upper extermity movement exercise and resistive exercises. |