| CTRI Number |
CTRI/2020/01/022881 [Registered on: 20/01/2020] Trial Registered Prospectively |
| Last Modified On: |
14/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Maitland techniques and specific exercise program on pain, function and range of motion in patients with neck pain. |
|
Scientific Title of Study
|
Effectiveness of Maitland techniques and specific exercise program on pain, function and range of motion in patients with cervical radiculopathy: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalyani Prakash Toshniwal |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy,Aurangabad |
| Address |
MGM Institute of Physiotherapy,N-6,Cidco, Aurangabad. OPD no.1,Musculoskeletal department,MGM Institute of Physiotherapy N6 cidco, Aurangabad 431003 Aurangabad MAHARASHTRA 431003 India |
| Phone |
8408999939 |
| Fax |
|
| Email |
kalyanitoshniwal3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sibi Daniel Joseph |
| Designation |
associate professor |
| Affiliation |
MGM Institute of Physiotherapy,N-6,Cidco, Aurangabad. |
| Address |
MGM Institute of Physiotherapy,N-6,Cidco, Aurangabad.
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9096834592 |
| Fax |
|
| Email |
sibdanjo2k@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Kalyani Prakash Toshniwal |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy,Aurangabad |
| Address |
MGM Institute of Physiotherapy,N-6,Cidco, Aurangabad. OPD no.1,Musculoskeletal department,MGM Institute of Physiotherapy N6 cidco, Aurangabad 431003 Aurangabad MAHARASHTRA 431003 India |
| Phone |
8408999939 |
| Fax |
|
| Email |
kalyanitoshniwal3@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy,N6 cidco, Aurangabad 431003 |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy Aurangabad |
| Address |
MGM Institute of Physiotherapy,N-6, Cidco Aurangabad-431003 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kalyani Prakash Toshniwal |
MGM Institute of Physiotherapy, Aurangabad |
OPD no.1,Musculoskeletal department,MGM Institute of Physiotherapy N6 cidco, Aurangabad 431003 Aurangabad MAHARASHTRA |
8408999939
kalyanitoshniwal3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ECRHS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maitland Manual therapy techniques,TENS,Neck isometrics, Moist heat therapy |
1)Maitland Manual therapy techniques:-
A) Rotation mobilization at cervical spine performed for 10repetions of 30 seconds with 3 to 4 grade, as described by Maitland et al.
B) Lateral glide in a flexed position at the cervical spine performed for 10 repetions of 30 seconds with 3 to 4 grade, as described by Maitland et al.
C) Anterosuperior lateral glide at the cervical spine performed for 10repetions of 30 seconds with 3 to 4 grade, as described by Maitland et al.
Any two of the above three techniques will be performed on the patients according to the results of biomechanical evaluation.
2)Home exercise program:-
A)Repeated active rotation movements (cervical spine rotation in the direction contralateral to the affected side) performed for 10 repetitions 10 times per day.
3)TENS:- Conventional TENS was applied for 30 mins. Stimulus was given in continuous trains of 150µs square pulse at 80Hz. Intensity was adjusted according to the patients comfort.
4) Neck Isometrics.
5) Moist heat therapy.
Each participant took part in 8 treatment sessions during a 4 week period.
|
| Comparator Agent |
TENS,Neck isometrics, Moist heat therapy.
|
1)TENS:- Conventional TENS was applied for 30 mins. Stimulus was given in continuous trains of 150µs square pulse at 80Hz. Intensity was adjusted according to the patients comfort.
2)Neck Isometrics .
3)Moist heat therapy.
Each participant took part in 8 treatment sessions during a 4 week period.
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) The subject should have pain, paresthesia, or numbness in 1 upper limb, with cervical or periscapular pain of less than 3 months in duration.
2) The subject should have positive responses to at least 3 of the 4 following clinical tests: spurling A test, upper-limb tension test A, cervical distraction test, and less than 60° of cervical rotation to the painful side.
|
|
| ExclusionCriteria |
| Details |
1) Previous history of surgery to the cervicothoracic spine.
2) Bilateral symptoms.
3) Signs of upper motor neuron impairments.
4) Cervical spine injection in the previous 4 weeks.
5) Current use on steroidal anti-inflammatory drugs. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Neck Disability Index:- neck pain related dysfunction.
2. Numeric Pain Rating Scale:- pain in neck and upper limb.
3. Cervicothoracic Mobility:- active cervical ROM.
Â
|
Baseline on the 1st day.
Post intervention at the end of 4th week.
Follow up after 1 month.
Â
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Neck Disability Index:- neck pain related dysfunction at the end of 4 weeks and after 3 months.
2. Numeric Pain-Rating Scale:- pain in neck and upper limb at the end of 4 weeks and after 3 months.
3. Cervicothoracic Mobility:- active cervical ROM at the end of 4 weeks and after 3 months.
Â
|
10-15 minutes |
|
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Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
21/01/2020 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This randomized controlled trial is to see the effectiveness of Maitland techniques and specific exercise program on pain, function and range of motion in 34 patients with cervical radiculopathy. Movements such as contralateral rotation, flexion, and contralateral side bending that increase the size of the IVF but may decompress an affected nerve root. Therefore, acute and subacute rehabilitation program for cervical radiculopathy should include techniques or exercises to increase the size of the IVF and, exclude movements and positions that decrease the size of the IVF. Since there was no control group included in this study the possibility of spontaneous resolution of symptoms could not be ruled out over the course of the study. So we decided to add a control group and see the effectiveness in the study. There will be two groups experimental group receiving manual therapy techniques (rotation mobilization, lateral glide, anterosuperior lateral glide at cervical spine), home exercise program, TENS, neck Isometrics, moist heat therapy and control group receiving same exercises as experimental group except manual therapy techniques and home exercise program. Patient will receive total 8 treatment sessions (twice in a week for a period of 4 weeks). The outcome measures will be Neck and disability index, cervicothoracic mobility (CROM), Numeric Pain-Rating Scale at baseline, at 4th week and after 1 month. |