| CTRI Number |
CTRI/2024/04/065194 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Exercises and Nerve Mobilization with neck Traction in Cervical Radiculopathy Patients |
|
Scientific Title of Study
|
Effect of McKenzie Exercises and Neural Mobilization Technique combined with Intermittent Cervical Traction in Patients with Cervical Radiculopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti |
| Designation |
BPT Student |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar
Hisar HARYANA 125001 India |
| Phone |
0 |
| Fax |
|
| Email |
jyoti200171710054@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Usha PT |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar
Hisar HARYANA 125001 India |
| Phone |
0 |
| Fax |
|
| Email |
ushasportsphysio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Jyoti |
| Designation |
BPT Student |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar
Hisar HARYANA 125001 India |
| Phone |
0 |
| Fax |
|
| Email |
jyoti200171710054@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar |
|
|
Primary Sponsor
|
| Name |
Jyoti |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar |
| 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 Usha PT |
Department of Physiotherapy Guru Jambheshwar University, Hisar |
OPD room no.4 Department of Physiotherapy Guru Jambheshwar University, Hisar Hisar HARYANA |
7056157540
jyoti200171710054@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
McKenzie Exercises with Intermittent Cervical Traction |
McKenzie Exercises with Intermittent Cervical Traction will be given to patients with cervical radiculopathy for 4 days per week for 4 weeks. |
| Comparator Agent |
Neural Mobilization Technique with Intermittent Cervical Traction |
Neural Mobilization Technique with Intermittent Cervical Traction will be given to patients with cervical radiculopathy for 4 days per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with Cervical radiculopathy for more than 6 months
Age 25-50 years
Both male and female
Positive Spurling’s test
|
|
| ExclusionCriteria |
| Details |
History of any injury or surgery around neck and shoulders
History of any other musculoskeletal, neurological, cardiopulmonary or psychological disorders
Patients who are non-cooperative
Patients currently on steroidal medication prescribed for radiculopathy symptoms
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Neck Disability |
The outcome measures will be assessed at baseline and after 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hand Grip
Cervical Proprioception |
The outcome measures will be assessed at baseline and after 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
15/04/2024 |
| 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="3" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 common condition characterized by pain, numbness, tingling and/or heaviness in arm as symptoms. The radiating pain is usually present along the distribution of a cervical nerve root. The average annual incidence rate of cervical radiculopathy is 83 per 100000 of population, with an increased prevalence occurring in the 5th decade of life (Dhuriya et al., 2021). The most commonly affected level is C5-C6 with 86% of affected population and the C6-C7 level is the next most frequently affected site. The involvement of the 8th cervical nerve root by a herniated C7-T1 disc produces a significant weakness of the intrinsic musculature of the hand which results in significant loss of fine movements of hand (Mohamed Faisal et al., 2012). The muscle weakness produced in one segment of the affected upper limb, would contribute to a generalized muscle weakness and consequently reduced hand strength (Nair et al., 2017). One of the lesser known impact of cervical spondylosis is on cervical joint position sense. As cervical spondylosis is a degenerative condition it can adversely affect the proprioceptive mechanism that regulate the neck position and movement (Alahmari and Reddy, 2024). The most common treatment for cervical radiculopathy is mechanical traction which is used to decompress the nerve root by separating the cervical segments through long-axis traction (Sarfaraj, 2018). Neural mobilization and McKenzie techniques when given with mechanical traction have improved pain and disability but there effects on hand grip and cervical proprioception need to explored in patients with cervical radiculopathy. As, neural mobilization mobilizes nerve tissue which results in reduced intrinsic pressure of the neural tissue and can re-establish the neural biomechanics such as elasticity etc. (Mohammed et al., 2019). The McKenzie techniques are used for treatment of the postural, dysfunctional and derangement syndromes in neck region. They have been proven to be effective in pain, neck disability and cervical muscle endurance in cervical radiculopathy individuals (Darji and Soni, 2022). Cervical radiculopathy is a common neuromusculo-skeletal disorder and presents great challenges for individuals with cervical spondylosis. There are paucity of literature on effect of McKenzie exercises and neural mobilization combined with intermittent cervical traction (ICT) on various parameters in cervical radiculopathy. Therefore, the current study is designed to compare the effectiveness of McKenzie technique and neural mobilization when combined to intermittent cervical traction on pain, neck disability, hand grip and neck proprioception in patients with cervical radiculopathy.
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