| CTRI Number |
CTRI/2023/09/057239 [Registered on: 04/09/2023] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| 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
|
Use of Nerve movement exercises on Sensitivity, Neck movements and Neck Pain. |
|
Scientific Title of Study
|
Effect of Median Nerve Neural Mobilization on Neuromuscular Mechanosensitivity, Neck Disability and Cervical Ranges in Non-Specific Neck Pain. |
| 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 Amita Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy, Dr. D.Y. Patil Vidyapeeth, Pune. |
| Address |
Department of Kinesiotherapy,Ist cabin 3rd floor,Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri, Pune,Maharashtra.411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalpita Kadam |
| Designation |
PG student |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy, Dr. D.Y. Patil Vidyapeeth, Pune. |
| Address |
PG classroom, Third floor,
Dr. D. Y. Patil College of Physiotherapy,Dr D .Y .Patil Vidhyapeeth ,
Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8454935799 |
| Fax |
|
| Email |
kalpitakadam99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy, Dr. D.Y. Patil Vidyapeeth, Pune. |
| Address |
Department of Kinesiotherapy,Ist cabin 3rd floor,Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri, Pune,Maharashtra.411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Amita Aggarwal |
| Address |
Department of Kinesiotherapy,Ist cabin 3rd floor,Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri, Pune,Maharashtra.411018 |
| 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 Amita Aggarwal |
Dr D.Y. Patil College of Physiotherapy ,Pimpri, Pune |
OPD, Basement, Dr D.Y. Patil College of Physiotherapy ,Pimpri, Pune
Pune
MAHARASHTRA |
7986972513
amita15pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr. D. Y. Patil College of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
For Conventional physiotherapy exercises will include active ROM neck exercises, stretching exercises for neck muscles, moist pack application at neck,isometric exercises for strengthening of neck muscles. It will be given 3 times in a week for 3 weeks . |
| Intervention |
Median nerve Neural Mobilization
with conventional physiotherapy |
The intervention will include- sliding technique of median nerve neural mobilization that is elongation of nerve bed with the alternation of elbow extension (loads the median nerve) and wrist flexion (unloads the median nerve).
Conventional physiotherapy includes active ROM neck exercises, stretching exercises for neck muscles, moist pack application at neck,isometric exercises for strengthening of neck muscles.
This intervention will be given for 3 times in a week for 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Adults (18-30 years) with non-specific neck pain, Absence of upper limb radiculopathy using ULTT1, Both acute and chronic non-specific neck pain, Grade 1 and grade 2 of non-specific neck pain, Presence of upper trapezius trigger point on either side or bilaterally as reported by PPT, Patient with written informed consent. |
|
| ExclusionCriteria |
| Details |
Prolapsed Intervertebral disc Myelopathy, Fibromyalgia, Any History of malignancy or infection; Any History of trauma (whiplash associated disorder);
having signs and symptoms of cerebrovascular insuficiency Vertigo, Dizziness, Red flags that require urgent attention Recent upper limb Fracture surgery 3 months Patinets with restricted shoulder elbow wrist ranges. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Visual Analogue Scale (VAS)
2) Full circle Goniometer
3) Neck Disability Index
4) Nerve Conduction Studies
5) Upper Limb Tension Test 1
6) Numerical Pain Rating Scale (NPRS) |
1)At the baseline.
2)At the end of the intervention (after 3 weeks, 9 sessions.) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pressure Pain Threshold |
1)At the baseline.
2)At the end of the intervention (after 3 weeks, 9 sessions.) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
AIM: To find the effect of Median Nerve Neural Mobilization on Neuromuscular Mechanosensitivity, Neck Disability and Cervical Ranges in Non-Specific Neck Pain OBJECTIVES:1. To find the affection of median nerve mechanosensitivity in dominant and non-dominant sides in patients with non-specific neck pain 2. To predict median nerve mechanosensitivity using Nerve Conduction Velocity (NCV) as a method of assessment in non-specific neck pain. 3. To find the effect of median nerve neural mobilization along with conventional therapy on Pain Pressure Threshold, Elbow ROM in ULTT position, NPRS, NCV, Neck Disability Index and Cervical ROM in non-specific neck pain. 4. To find the effect of conventional therapy on Pain Pressure Threshold, Elbow ROM in ULTT position, NPRS, NCV, Neck Disability Index and Cervical ROM in non-specific neck pain. 5. To compare the effect of conventional therapy with and without neural mobilization on Pain Pressure Threshold, Elbow ROM in ULTT position, NPRS, NCV, Neck Disability Index and Cervical ROM in non-specific neck pain.
NULL HYPOTHESIS: There may be no significant effect of Median Nerve Neural Mobilization on Neuromuscular Mechanosensitivity, Neck Disability and Cervical Ranges in Non-Specific Neck Pain ALTERNATIVE HYPOTHESIS: There may be a significant effect of Median Nerve Neural Mobilization on Neuromuscular Mechanosensitivity, Neck Disability and Cervical Ranges in Non-Specific Neck Pain |