| CTRI Number |
CTRI/2025/03/082703 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Total 52 participants with cervical radiculopathy will randomly divided into 2 groups in which Group 1 receive conventional therapy and Maitland thoracic spine mobilization and group 2 receive conventional therapy 3 sessions per weeks for 3 weeks. |
|
Scientific Title of Study
|
Effect of Maitland mobilization of thoracic spine on pain, cervical range of motion and functional status in patients of cervical radiculopathy - An experimental study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khyati Parmar |
| Designation |
PG physiotherapy student |
| Affiliation |
Government Physiotherapy College Jamnagar |
| Address |
Room no. 33, OPD 1, Exercise therapy department, Government Physiotherapy College,
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
6356388575 |
| Fax |
|
| Email |
khyatiparmar63563@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Sorani |
| Designation |
Principal of government physiotherapy college |
| Affiliation |
Government Physiotherapy College Jamnagar |
| Address |
Room No 3, Exercise therapy department, Government Physiotherapy College,
Jamnagar.
Jamnagar
GUJARAT
361008
India |
| Phone |
9426786167 |
| Fax |
|
| Email |
soranidinesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khyati Parmar |
| Designation |
PG physiotherapy student |
| Affiliation |
Government Physiotherapy College Jamnagar |
| Address |
Room no. 33, OPD 1, Exercise therapy department, Government Physiotherapy College,
Jamnagar
near dental college,
Jamnagar
GUJARAT
361008
India |
| Phone |
06356388575 |
| Fax |
|
| Email |
khyatiparmar63563@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Physiotherapy College Jamnagar |
|
|
Primary Sponsor
|
| Name |
Government Physiotherapy College Jamnagar |
| Address |
Government physiotherapy college jamnagar,
near dental college,
Rameshwar Nagar,
Jamnagar - 361008 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Khyati Parmar |
Government Physiotherapy College Jamnagar |
Room no. 33, OPD 1, Exercise therapy department, Government Physiotherapy College,
Jamnagar
Jamnagar
GUJARAT |
6356388575
khyatiparmar63563@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee shree M P shah Govt. medical college and G G govt. hospital, jamnagar |
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 |
| Intervention |
Conventional physical therapy for cervical radiculopathy |
intermittent cervical traction (ICT), shortwave diathermy (SWD), interferential therapy (IFT), stretching and strengthening of neck muscles
3 sessions per week for 3 weeks |
| Comparator Agent |
Conventional physical therapy for cervical radiculopathy + Maitland thoracic spine mobilization |
intermittent cervical traction (ICT), short wave diathermy (SWD), interferential therapy (IFT), stretching and strengthening of neck muscles, Maitland mobilization of thoracic spine
3 sessions per week for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate and individuals having 3 positive findings out of following:
1.neck pain with radiating pain in the involved
extremity
2.neck and neck related radicular pain reproduced by
radiculopathy testing: positive upper
limb tension test
3.positive spurling test, cervical distraction test
4.restricted cervical range of motion |
|
| ExclusionCriteria |
| Details |
subjects who have cognitive deficits, language deficits, spinal surgery and fracture, fracture of upper limb, spinal tumor, any skin condition, infection, neoplastic disorder, age more than 60 years |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
numeric pain rating scale (NPRS),
neck disability index (NDI),
cervical range of motion |
At baseline (on 1st day) and after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| neck disability index (NDI) |
At baseline (on 1st day) and after 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
20/03/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
I will collect the data of patients coming to government physiotherapy college- OPD, Jamnagar. Patients who fit selection criteria will be selected. Consent will be taken from patients and patients with cervical radiculopathy will be assessed for pain, cervical range of motion, and functional status. Treatment will be given as Maitland thoracic spine mobilization for 3 weeks (3 days per week) along with traditional physiotherapy treatment and post intervention assessment will be taken at the end of 3 weeks. Data will be collected over a period of 8 months. |