| CTRI Number |
CTRI/2019/05/019382 [Registered on: 27/05/2019] Trial Registered Prospectively |
| Last Modified On: |
15/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Mulligan verses conventional Neurodynamic technique in cervical radiculopathy |
|
Scientific Title of Study
|
A Comparative Study of Mulligan Mobilization Versus Conventional Neurodynamic Mobilization on Pain Disability & Cervical ROM in Treatment of Cervical Radiculopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiotherapy 1st Cabin,3rd floor,Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiotherapy 1st Cabin,3rd floor,Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruvitte Gomes |
| Designation |
PG student |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
PG-1 Classroom,3rd floor,Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673756713 |
| Fax |
|
| Email |
ruvittegomes@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amita Aggarwal (Self) MPT Assistant Professor Dr. D.Y. Patil College of Physiotherapy Dr. D.Y. Patil Vidyapeeth, Sant Tukaram Nagar Pimpri -18 Pune Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Amita Aggarwal |
| Address |
Flat No. 1004 A wing Kamalraj Haridwar Society,Dighi,Pune 411015 |
| 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 |
| Amita Aggarwal |
Dr D.Y.Patil College of Physiotherapy,Pimpri,Pune |
Department of Kinesiotherapy 1st CABIN, 3rd floor, D. Y. Patil College of Physiotherapy. Sant Tukaram Nagar, Plot No. BGP/190, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
7986972513
amita15pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y. Patil Vidyapeeth ,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M501||Cervical disc disorder with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulligan Neurodynamic Mobilization |
The glides will be given for three repetitions , three sets for 5 days. To progress the treatment at subsequent sessions, the number of repetitions can be increased from 3 to 6 |
| Comparator Agent |
Neurodynamic mobilization |
Treatment will include 3 rep, 3sets for 5 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Unilateral radiating pain from neck to upper limb with atleast one ULTT positive
2 Dermatomal involvement of the affected nerve root.
3 Clinically diagnosed & referred by an orthopaedic surgeon
|
|
| ExclusionCriteria |
| Details |
1 Recent history of trauma, fall or injury to cervical region
2 Bilateral upper extremity radicular symptoms
3 UMN signs like gait changes, fine motor changes & hyperreflexia
4 Myelopathies
5 Severe Osteoporosis
6 Active infection
7 Hypermobile joints
8 Vertigo
9 Dizziness
10 Vertebral Basilar artery Insufficiency
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (NPRS)
Patient Specific Functional Scale(PSFS)
Cervical ROM
|
On first day and fifth day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/07/2019 |
| Date of Study Completion (India) |
03/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Title-A Comparative Study of Mulligan Neurodynamic Mobilization Versus Conventional Neurodynamic Mobilization on Pain, Disability & Cervical ROM in Treatment of Cervical Radiculopathy Need of the study- There is paucity of research evidence that includes mulligan technique along with neurodynamics as well as there is paucity of studies that compare Mulligan neurodynamic mobilization with conventional neurodynamics to see which approach was more effective than the other. Objective of study- 1) To assess the effectiveness of Mulligan neurodynamic mobilization on pain, cervical ROM & disability in cervical radiculopathy patients. 2) To assess the effectiveness of conventional neurodynamic mobilization on pain, cervical ROM & disability in cervical radiculopathy patients. 3) To find out which of the two techniques was more effective in reducing pain,cervical ROM and disability in cervical radiculopathy patients. Methodology- Based on inclusion and exclusion criteria subjects will be divided into two groups. Group A will be given Mulligan mobilization using SNAGs and Spinal mobilization with arm movements Group B will be given neurodynamic mobilization Treatment will be given for total of 5 sessions.Patients will be evaluated for pain,disability and Cervical Range of motion using NPRS(Numerical pain rating scale),Patient specific functional scale and universal goniometer. RESULTS: The
test reveals similar improvements in pain and disability in both groups
(p>0.05), however the Mulligan Neurodynamic Mobilization Group showed better
results in terms of cervical ranges (p<0.05).
CONCLUSION: Mulligan
Neurodynamic Mobilization techniques were found to be superior in terms of
improving cervical ranges especially cervical extension, rotation and lateral
flexion in patients with cervical radiculopathy. With respect to pain and
disability either technique had similar effect in reducing pain and disability. |