| CTRI Number |
CTRI/2025/05/086272 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Immediate effect of neural tissue mobilization technique on cervical pain and range of motion in individuals with neck pain. |
|
Scientific Title of Study
|
Immediate effect of neurodynamic mobilization on pain, pressure
sensitivity and cervical range of motion in individuals with upper trapezius myofascial pain
syndrome – A single blinded 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 |
Dr Sakshi Ashish Parekh |
| Designation |
Masters Of Musculoskeletal Physiotherapy Student |
| Affiliation |
KJ Somaiya College of Physiotherapy Sion |
| Address |
KJ Somaiya College of Physiotherapy,
Musculoskeletal OPD number 4,
Ayurvihar,
Eastern express highway Sion Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7738336636 |
| Fax |
|
| Email |
sakshi.parekh@somaiya.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Shevalkar |
| Designation |
Associate Professor |
| Affiliation |
KJ Somaiya College of Physiotherapy Sion |
| Address |
KJ Somaiya College of Physiotherapy,
Musculoskeletal OPD number 4,
Ayurvihar,
Eastern express highway Sion Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8898737701 |
| Fax |
|
| Email |
rupali.salvi@somaiya.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Shevalkar |
| Designation |
Associate Professor |
| Affiliation |
KJ Somaiya College of Physiotherapy Sion |
| Address |
KJ Somaiya College of Physiotherapy,
Musculoskeletal OPD number 4,
Ayurvihar,
Eastern express highway Sion Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8898737701 |
| Fax |
|
| Email |
rupali.salvi@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| KJ Somaiya College of Physiotherapy
Mumbai - 400022 , India |
|
|
Primary Sponsor
|
| Name |
KJ Somaiya College of Physiotherapy Sion |
| Address |
KJ Somaiya College of Physiotherapy,
Musculoskeletal OPD number 4,
Ayurvihar,
Eastern express highway Sion Mumbai 400022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sakshi Ashish Parekh |
KJ Somaiya College of Physiotherapy Sion |
KJ Somaiya College of Physiotherapy,
Musculoskeletal OPD number 4,
Ayurvihar,
Eastern express highway Sion Mumbai 400022
Mumbai
MAHARASHTRA |
7738336636
sakshi.parekh@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee K J Somaiya College Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard physio therapy protocol |
a. The treatment session will start with application of hydrocollator pack for 10 minutes over the upper trapezius region.
b. This will be followed by stretching of upper trapezius of the affected side for 30 sec hold and 3 repetition with 20 second break in between (13). Patient position: supine. Therapist position: standing behind the patient. Technique: Therapist passively places participants head into flexion, lateral flexion away from the affected side and rotation towards the affected side until the muscle barrier is met. The therapist then depresses the participant’s shoulder. This was repeated thrice with 20 sec breaks in between.
c. Following this active range of motion exercise for all the motions of the cervical spine will be give this includes cervical flexion, extension, lateral flexion towards right and left side , rotation towards right and left side in sitting. This will be repeated 10 times for each range.
d. Following this posture correction exercise like chin tuck and scapular retraction for 10seconds hold 10 repetitions will be given.
The total duration of intervention will be 25 mins
|
| Intervention |
Standard physiotherapy protocol along with Neurodynamic mobilization |
a. Treatment will be started with application of hydrocollator for 10 min over the upper trapezius region.
b. This will be followed by neurodynamic mobilization. The standard upper limb neurodynamic test l or, median neurodynamic test 1 (MNT1) as described by Shacklock, which moves almost all the nerves between the neck and hand, including the median, radial and ulnar nerves, brachial plexus, spinal nerves and cervical nerve roots. The patient will be in supine position, they will be taken to the end position of MNT1 or to the points where positive normal response is felt which resists further movement. Two ended sliders will be given. Concurrent shoulder abduction and ipsilateral cervical lateral flexion followed by shoulder adduction and contralateral cervical lateral flexion will be given. The therapist will alternate the combination of movement depending upon the tissue resistance level.
DURATION OF TREATMENT: 4 sets of 30 repetitions separated by a 30-s rest period, as Shacklock (2005) recommended
c. This will be followed by stretching of upper trapezius. DOSAGE: 30 sec hold, 3 repetitions with 20sec break in between each repetition.
d. Following active range of motion for all the cervical spine ranges will be given. DOSAGE: 10 repetitions for each movement.
e. Following this posture correction exercise like chin tuck and scapular retraction for 10seconds hold 10 repetitions will be given.
Total Duration of this intervention will be 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
Individuals in the age group of 18 to 40 years having unilateral or bilateral (more severe side in case of bilateral) myofascial pain syndrome of upper trapezius, Having minimum pain intensity 30mm based on VAS, Presence of at least one active trigger point in upper trapezius based on Simon’s criteria which included 1-taut band in upper trapezius muscle, 2- point sensitive to touch in upper trapezius muscle, 3- recognition of spreading pain in upper trapezius muscle after the application of pressure on the trigger points (posterior and lateral of cervical spine, temporal, supraorbital, maxillary, and mandibular areas on the affected side) (2). Patients who are willing to participate and will give consent for the same. |
|
| ExclusionCriteria |
| Details |
1)Any diagnosed inflammatory condition (eg: rheumatoid disease)
2)Fracture or dislocation of cervical vertebrae
3)Any diagnosed pathology related to cervical spine or shoulder
4)Recent Cervical spine or shoulder surgery
5)Radiculopathy or neuropathy affecting upper extremity
6)cognitive impairments that prevent them from following instructions
7)Patients undergoing treatment over the last 3 months targeting the trigger points.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Visual Analogue Scale (VAS)
2.Pressure algometer
3.Cervical range of motion - Lateral flexion ,Rotation |
1. pre assessment -- baseline assessment will we done immediately prior to giving intervention
2. post-assessment -- Immediately after giving the intervention assessment will be done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
16/05/2025 |
| 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
|
Approval
will be obtained from the institutional ethics committee. Subjects will be
recruited according to inclusion criteria on basis of voluntary participation
and written consent form will be signed by the participants. Demographic
data will be obtained and filled in the case record sheet. Subjects will
be randomly allocated by the SNOSE technique using computer-generated numbers
into Group A and B. Pre-treatment assessment will be done for pain using
Visual Analogue scale, pressure sensitivity using digital pressure algometer
and cervical lateral flexion and rotation range of motion using Universal
goniometer. Each group will have 20 participants. Group A participants
will receive standard physiotherapy protocol and group B participants will
receive neurodynamic mobilisation along with standard physiotherapy protocol.
Immediately Post treatment assessment will be taken for pain using visual
analogue scale (VAS), pressure sensitivity using digital algometer and cervical
lateral flexion and rotation range of motion using universal goniometer. Single
blinding will be maintained as intervention and assessment will be done
by two different investigators .The assessor will be blinded throughout the
procedure. Statistical Analysis will be done, Test for normality will be
done using Shapiro Wilk Test. If data follows normality, Test that
will be applied for pre-post comparison in the group – Paired t-test and test
that will be applied for comparison between the group – Unpaired
t-test. If data does not follow normality, Test that will be done for
pre-post comparison in the group – Wilcoxson sign rank test, test that
will be done for comparison between the group – Mann Whitney test.
|