| CTRI Number |
CTRI/2025/11/098116 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking if the DASH test works well and gives the same results again and again in people with neck-related arm pain. |
|
Scientific Title of Study
|
Establishing concurrent validity and reliability of dash scale in cervicoradiculopathy subjects cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Khadkodkar |
| Designation |
PG Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
306, Physiotherapy department, Parul Institute of Physiotherapy, Parul University, PO. Limda, Tal. Waghodia, Vadodara, Gujarat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
9981825677 |
| Fax |
|
| Email |
khadkodkarshivani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Advita Neville Deepak |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
306, Physiotherapy department, Parul Institute of Physiotherapy, Parul University, PO. Limda, Tal. Waghodia, Vadodara, Gujarat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
8320655918 |
| Fax |
|
| Email |
advita.deepak@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Advita Neville Deepak |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
306, Physiotherapy department, Parul Institute of Physiotherapy, Parul University, PO. Limda, Tal. Waghodia, Vadodara, Gujarat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
8320655918 |
| Fax |
|
| Email |
advita.deepak@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy department, Parul Institute of Physiotherapy, Parul University, PO. Limda, Tal. Waghodia, Vadodara, Gujarat, India. 391760 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
| Shivani Khadkodkar |
Parul University |
306, Physiotherapy department, Parul Institute of Physiotherapy, Parul University, PO. Limda, Tal. Waghodia, Vadodara, Gujarat, India.
Vadodara
GUJARAT |
09981825677
khadkodkarshivani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PUIECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Physiotherapy Rehabilitation Exercises |
Neck Strengthening Exercises:
Isometric exercises for cervical flexion, extension, and rotation (hold for 5-10 seconds, 10-15 reps, 2-3 sets).
Deep cervical flexor strengthening (chin tucks, hold for 5 seconds, 10 reps).
Upper Limb Strengthening:
Shoulder strengthening (e.g., shoulder shrugs, scapular retractions).
Arm exercises (e.g., bicep curls, wrist curls).
Stretching Exercises:
Neck stretches (flexion, extension, lateral flexion, rotation).
Upper limb stretching (shoulder, forearm, wrist).
Postural Correction:
Neutral spine exercises: Focus on head and neck alignment, especially during sitting and standing.
Neuromuscular Re-education:
Proprioceptive training: Head and neck position awareness exercises.
Nerve gliding exercises (e.g., median nerve glide).
Functional Training:
Task-specific exercises: Lifting, reaching, and carrying tasks.
Ergonomic training: Proper work posture and lifting techniques.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Neck Strengthening Exercises:
Isometric exercises for cervical flexion, extension, and rotation (hold for 5-10 seconds, 10-15 reps, 2-3 sets).
Deep cervical flexor strengthening (chin tucks, hold for 5 seconds, 10 reps).
Upper Limb Strengthening:
Shoulder strengthening (e.g., shoulder shrugs, scapular retractions).
Arm exercises (e.g., bicep curls, wrist curls).
Stretching Exercises:
Neck stretches (flexion, extension, lateral flexion, rotation).
Upper limb stretching (shoulder, forearm, wrist).
Postural Correction:
Neutral spine exercises: Focus on head and neck alignment, especially during sitting and standing.
Neuromuscular Re-education:
Proprioceptive training: Head and neck position awareness exercises.
Nerve gliding exercises (e.g., median nerve glide).
Functional Training:
Task-specific exercises: Lifting, reaching, and carrying tasks.
Ergonomic training: Proper work posture and lifting techniques.
|
|
| ExclusionCriteria |
| Details |
Cardiopulmonary deficit , chronic kidney disease ,endocranial disorder ,neurological disorder .
Presence of visual acuity deficit
Significant perceptual ,cognitive , or communication impairment
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| DASH (Disabilities of the arm, shoulder and hand)Scale |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CRIS (Cervical radiculopathy impact scale) |
4 weeks |
|
|
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)
|
10/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Cervical radiculopathy is a condition characterized by nerve compression which can lead to pain weakness and sensory loss in arm and shoulder. According to W.Magnus in 2023, he concluded that cervical radiculopathy incidence rate are very common and affect day to day life. The DASH questionnaire is widely used to asses upper-limb disability but it is not condition specific therefore, validating its use in cervical radiculopathy cases by correlating it with a condition -specific tool like the CRIS scale is necessary. By evaluating the reliability and concurrent validity of DASH with reference to CRIS scale, it determine whether DASH accurately measures functional impairment specific to Cervical-radiculopathy. By conducting this study the research will fill an important gap in literature and provide evidence regarding the use of DASH for assessing functional impairment in cervical radiculopathy subjects. Establishing the concurrent validity and reliability of DASH. |