| CTRI Number |
CTRI/2024/09/073663 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
effect of dry needling versus neural mobilisation on pain and quality of life in cervical radiculopathy patients |
|
Scientific Title of Study
|
Effect of Neural Mobilisation Versus Dry Needling on Pain, Functional Disability, Range of Motion and Quality of Life on Cervical Radiculopathy-A Randomized Clinical 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 |
Aaliya Sayad |
| Designation |
postgraduate student |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
KAHER Institute of physiotherapy, advanced physiotherapy centre
OPD no.39 neurology department, OPD no.19, JNMC campus,
nehru nagar, belagavi-590010, karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
7972662408 |
| Fax |
|
| Email |
aaliya12112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghavendrasingh Dharwadkar |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
KAHER Institute of physiotherapy, advanced physiotherapy centre
OPD no.39 neurology department, OPD no.19, JNMC campus,
nehru nagar, belagavi-590010, karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Raghavendrasingh Dharwadkar |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
KAHER Institute of physiotherapy, advanced physiotherapy centre
OPD no.39 neurology department, OPD no.19, JNMC campus,
nehru nagar, belagavi-590010, karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and research centre, nehru nagar, belagavi. Pin code- 590010 |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of physiotherapy |
| Address |
KAHER Institute of physiotherapy,JNMC campus,nehru
nagar,belagavi |
| 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 |
| Aaliya Sayad |
KAHER Institute of Physiotherapy |
Advanced
Physiotherapy Centre
room no. 39, neurology
department,OPD no-19
Sagar Floor KLE Dr.
Prabhakar Kore
Hospital Belagavi
karnataka
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
07972662408
aaliya12112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics and Research Committee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dry needling |
dry needling will be done 3 times a week for 2 weeks |
| Intervention |
neural mobilisation |
neural mobilisation will be done for the affected nerve 3 times a week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate, between the age group of 35-50 years of all the genders having unilateral cervical radiculopathy with positive Spurling’s compression test and upper limb tension test
Neck pain equal to or more than five as per Visual analogue scale (VAS)
|
|
| ExclusionCriteria |
| Details |
Patients with previous cervical surgeries, loss of upper limb movement, traumatic history, fractures, osteoporosis, hypermobility, circulatory disturbances, tumor-causing cervical radiculopathy , cervical or thoracic spine surgery, vestibulobasilar insufficiency, fear of needles, pregnancy and metal allergy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visual analogue scale |
0-no pain
10- highest pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| northwick park pain questionnaire |
0-4
0-no disability
4- highest level of disability |
| 36 –item short form health survey |
0-lowest score
100-highest score |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/09/2024 |
| Date of Study Completion (India) |
13/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The
dysfunction of a cervical spine nerve root is known as cervical radiculopathy.
It is typically caused by a cervical
disc herniation, spondylotic spur, cervical osteophyte, or other
space-occupying lesion. This can induce inflammation or impingement of the
nerve root, or both. Nerve
gliding exercises are a series of movements performed on the upper or lower
limb to lengthen nerves.(5) Because of
their quick pain relief, neurodynamic mobilisation methods (NMTs) are
recommended in the treatment of cervical radiculopathy. Dry
needling (DN) is a needle insertion
technique using a fine, solid needle without anesthetic or injection. The
needle is inserted subcutaneously. DN differs from acupuncture, which employs
the concepts of Traditional Chinese Medicine but applies a solid filiform
needle.Neural
mobilization and dry needling have been studied independently and have shown
positive results. There is a dearth in literature regarding the comparative
effects of these two interventions.group 1 is neural mobilisation. group 2 is dry needling. treatment will be given for 3 days/ week for 2 weeks.
|