| CTRI Number |
CTRI/2008/091/000187 [Registered on: 10/10/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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To study The Effect of Manual Therapy and Nerve Mobilisation which are two physiotherapy methods in treating patients with Cervical Radiculopathy- A pilot Study |
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Scientific Title of Study
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The Effect of Manual Therapy and Nerve Mobilisation in Managing Cervical Radiculopathy ? A Single Blinded Randomized Controlled Clinical Trial-Pilot Study |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jenab Petant |
| Designation |
|
| Affiliation |
|
| Address |
Shree Ghantakaran Mahavir Physiotherapy College and Rehabilitation Research Center,
Kanelav Road, Vavdi
Not Applicable
N/A
389001
India |
| Phone |
02672265039 |
| Fax |
02672265276 |
| Email |
zainabsgmpc@yahoo.com |
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Details of Contact Person
Scientific Query
|
| Name |
Jenab Petant |
| Designation |
|
| Affiliation |
|
| Address |
Shree Ghantakaran Mahavir Physiotherapy College and Rehabilitation Research Center,
Kanelav Road, Vavdi
Not Applicable
N/A
389001
India |
| Phone |
02672265039 |
| Fax |
02672265276 |
| Email |
zainabsgmpc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Jenab Petant |
| Designation |
|
| Affiliation |
|
| Address |
Shree Ghantakaran Mahavir Physiotherapy College and Rehabilitation Research Center,
Kanelav Road, Vavdi
Not Applicable
N/A
389001
India |
| Phone |
02672265039 |
| Fax |
02672265276 |
| Email |
zainabsgmpc@yahoo.com |
|
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Source of Monetary or Material Support
|
| Material Support |
| Shree Ghantakaran Mahavir Physiotherapy College and Rehabilitation Research Center, Godhra |
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Primary Sponsor
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| Name |
Principal Applicant |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| S.Srikesavan Sabapathy |
1)Shree Ghantakaran Mahavir physiotherapy college and Rehabilitation Research Center |
Kanelav Road, Vavdi,-389001
|
02672265039
02672265276
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Shree Ghantakaran Mahavir Physiotherapy College and Rehabilitation Research Center, Godhra |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Patients with Cervical Radiculopathy , |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Short wave diathermy using disc electrodes for 20 minutes once a day for 14 days. Intermittent cervical traction for 20 minutes once a day for 14 days. Isometric and Active neck exercises done in the department itself for 20 minutes once a day for 14 days. |
| Intervention |
Maitland's Mobilisation |
Transverse vertebral pressure, Postero-anterior central vertebral pressure, Postero-anterior unilateral vertebral pressure will be given according to the grades described by Maitland. The dosage would involve around 100 oscillations given in two sets with a rest in between in single treatment session for 14 days which is the duration of the study. |
| Intervention |
Neural Mobilisation |
Neural mobilization for the Affected Upper limb is given. Initially the treatment session consists of a sequence of gentle oscillations for 10 to 20 seconds and progression will be attained by increasing the number of repetitions and depending upon the effects will be extended up to a minute. |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1.Patients Diagnosed with Cervical radiculopathy by medically qualified doctors 2.Patients found to be having cervical radiculopathy by using the Clinical Prediction Rule for Cervical Pain by Wainner et al. 3.Age from 30 years to 60 years 4.Patients of Both genders. |
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| ExclusionCriteria |
| Details |
1.Patients with Cervical Instability 2.Patients with Central compressions 3.Patients with spinal tumors 4.Patients with spinal infections |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| (1)Pain measured by the Numerical Pain Rating Scale (NPRS) in Gujarati. (2)Range of Motion using the Universal 180 degree metal goniometer (3)Functional Disability Outcome using the Neck Disability Index (NDI) (4) Rate of change using the Global Rate of change scale (GROC) |
Measurements taken on the 1st,7th and 14th day of study |
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Secondary Outcome
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| Outcome |
TimePoints |
| NIL |
NIL |
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Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a pilot study being done to calculate the sample size and at the same time find the feasibility for a larger study with a large sample size. The study is a randomized single blind study. The main objective of the study is to find the effect of Maitland's manual therapy and Nerve mobilisation which are two methods of treatment frequently used in physiotherapy against a control group which would be receiving Conventional physiotherapy. The duration of the study would be 2 months. |