| CTRI Number |
CTRI/2024/06/069614 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Our study includes patients with pinched neck nerves who will receive neural mobilization (gentle stretches to improve nerve mobility and reduce pain) and pain neuroscience education (teaching about pain for better understanding and control) to see its effect on pain, function, and quality of life. |
|
Scientific Title of Study
|
Effectiveness of Neural Tissue Mobilization along with Pain Neuroscience Education on Pain, Self-reported Function, and Quality of Life in Patients with Cervical Radiculopathy – A Pilot 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 Gargee Deutkar |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad. |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-1, MGM
Institute of Physiotherapy, Aurangabad.
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9403026159 |
| Fax |
|
| Email |
gad.gargee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-1, MGM
Institute of Physiotherapy, Aurangabad.
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
sanketmungikar@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-1, MGM
Institute of Physiotherapy, Aurangabad.
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
sanketmungikar@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy N-6 Cidco, Aurangabad,431003 Maharashtra,India. |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6 Cidco, Aurangabad,431003 Maharashtra,India. |
| 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 Gargee Deutkar |
MGM Medical College and Hospital |
Musculoskeletal
Physiotherapy
Department,
OPD-1,MGM Institute of
Physiotherapy, N-6
Cidco, Aurangabad
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
9403026159
gad.gargee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Reseach on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M501||Cervical disc disorder with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
A routine conventional physiotherapy protocol will be given to the patients with cervical radiculopathy in the control group for 4 weeks (5 sessions per week for 4 weeks).
1. Heat application with hot pack will be given for 20 mins in the neck region.
2. Cervical isometric exercises for cervical flexors, extensors, lateral flexors and rotators with 10 seconds hold and release, rest interval: 3 seconds x 10 repetitions x 1set
3. Stretching of the trapezius and levator scapulae muscles with 30 second hold x 3 repetitions x 1set.
4. Chin-nod for activation of deep cervical flexors and scapular retraction exercises for postural corrections x 10 repetitions x 1set.
5. Exercises comprising of upper-back strengthening (lower and middle trapezius muscles, rhomboids) Y, W and T exercises, serratus anterior muscle strengthening that will be performed with 5s hold x 10 repetitions (Rest interval: 3 sec).
6. The application of TENS Modality for pain - 20 minutes (Pulse duration: 50 μs, frequency: 100 Hz) in cervical region and along the arm.
|
| Intervention |
Neural tissue
mobilization along with Pain
neuroscience education and Conventional physiotherapy. |
Patients with cervical radiculopathy will be given -
I) Neural Tissue Mobilization
1. The neural tissue mobilization techniques will be given according to Michael Shacklock.
2. The treatment protocol will be based on persons symptoms and assessment and may vary from person to person.
3. 5 sessions per week for 4 weeks will be given.
A) Reduced closing dysfunction will be treated with LEVEL 1 - Progression 1 - Static Opener, Level 1 - Progression 2 - Dynamic opener, LEVEL 2- Progression 1 - Dynamic closer - mid-range, Progression 2 - dynamic closer - gentle end range.
B) Reduced opening dysfunction will be treated with Level 1- dynamic opener, Level 2 will move from low to higher, entering the mid-range and outer, or end range.
C) Neural dysfunctions treated with Generalized two-ender slider.
D) Tension dysfunction treated with Low level 1 - position away/move away, High level 1 - position towards/move away, Level 2 - position away/move towards, level 3 progression is sensitization.
E) In patients with muscle dysfunction muscle release techniques in the upper limb neurodynamic position will be performed.
F) Mobilization for reduced opening dysfunction.
G) Mobilization for reduced closing dysfunction and neural tension dysfunction.
II) Pain neuroscience education
1. A total of 4 PNE sessions will be held, once each week, for four weeks in four separate meetings.
2. The PNE sessions will be conducted by the same physiotherapist who will deliver the treatment.
3. The sessions will be conducted face-to-face, one-on-one sessions lasting 20–30 minutes.
4. The PNE will be through Power Point presentations. It will incorporate metaphors, plain language, examples, charts, diagram, and pictures to assist in patient learning.
III) Conventional physiotherapy.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Unilateral radicular symptoms in the arm.
2. Pain on NPRS ≥ 3.
3. Diagnosis of cervical radiculopathy (Clinical Prediction Rule) will be applied i.e. consisting of spurling’s test, distraction test, and ULTT (Upper Limb Tension Test) for Median Nerve positive.
4. No previous cervical spine surgeries.
|
|
| ExclusionCriteria |
| Details |
1. History of recent cervical trauma.
2. Sensory loss and motor weakness (e.g. Myelopathy).
3. Any neurological conditions (e.g. Stroke).
4. Patients affected with shoulder disorders (e.g. Instability, Rotator cuff tears)
5. Any systemic disease (e.g. Rheumatoid Arthritis)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
Pre intervention, 2nd week, post intervention(4th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Self-reported function |
Pre intervention, 2nd week, post intervention(4th week) |
| Quality of Life |
Pre intervention, 2nd week, post intervention(4th week) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| Date of Study Completion (India) |
26/08/2025 |
| Date of First Enrollment (Global) |
08/07/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Patients
with Cervical radiculopathy (n=30) will be included in the study trial if they
met the inclusion criteria. The written and oral consent of all patients will
be taken, and procedure will be explained to them. Demographic details will be noted
of those participants who will provide their written informed consent to take
part in the study. After completing the demographic data, outcome measures of
the participants will be assessed by providing the scales (NPRS, PSFS, and
SF-12). The participants will be asked to fill up the self-administrable
scales, regarding their pain, function, and quality of life respectively. The
Scales responses will be recorded prior to the treatment or intervention (pre-assessment).
Thereafter, allocation will be done 1:1 through concealed envelope method into
the two groups i.e. Group A (Intervention group) and Group B (Control group).
Four weeks of treatment will be given to both the groups (5 sessions per week
for 4 weeks). Group A (intervention group) will be given-
A) A). Neural
tissue mobilization - The neural tissue mobilization techniques will be given
according to Michael Shacklock. The treatment protocol will be based on persons
symptoms and assessment and may vary from person to person.
B) B). Pain
neuroscience education - A total of 4 PNE sessions will be held, once each
week, for four weeks in four separate meetings. The PNE sessions will be
conducted by the same physiotherapist who will deliver the treatment. The
sessions will be conducted face-to-face, one-on-one sessions lasting 20–30
minutes. The PNE will be through Power Point presentations.
C) C). Conventional
physiotherapy Group B will be given only Conventional physiotherapy i.e. Exercises +
TENS (Hot moist pack, cervical isometrics, stretching for trapezius and leavtor
scapulae, chin nod and scapular retractions, and strengthening of the upper
back muscles i.e. Y, W, T exercises). Second assessment will be done after 2
weeks and the final post-assessment will be done at the end of 4th week. Same
scales will be used in post assessment (NPRS, PSFS, and SF-12). Statistical
analysis of the collected data will be done. Conclusion will be established
based on the obtained results of the study. |