| CTRI Number |
CTRI/2018/05/014144 [Registered on: 25/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/04/2018 |
| 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
|
Comparing the effect of two nerve specific treatment techniques on pain and function in patients with tingling in one leg |
|
Scientific Title of Study
|
Comparison of effectiveness of Butler’s and Shacklock’s technique of neural tissue mobilization on pain and disability in patients with unilateral lower limb radiculopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanchan Musmade |
| Designation |
PG student |
| Affiliation |
sancheti institue college of physiotherapy |
| Address |
Sancheti healthcare academy ,
Sancheti institute college of physiotherapy ,
11/12 thube park , shivajinagar
Pune
MAHARASHTRA
pune: 411005
India |
| Phone |
8237015624 |
| Fax |
|
| Email |
kanchanmusmade24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sona Kolke |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Sancheti healthcare academy ,
Sancheti institute college of physiotherapy ,
11/12 thube park , shivajinagar
Pune
MAHARASHTRA
pune: 411005
India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanchan Musmade |
| Designation |
PG student |
| Affiliation |
sancheti institue college of physiotherapy |
| Address |
Sancheti healthcare academy ,
Sancheti institute college of physiotherapy ,
11/12 thube park , shivajinagar
Pune
MAHARASHTRA
pune: 411005
India |
| Phone |
8237015624 |
| Fax |
|
| Email |
kanchanmusmade24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Healthcare Academy,
Sancheti Institute College of Physiotherapy ,
11/12 thube park , shivajinagar |
|
|
Primary Sponsor
|
| Name |
sancheti institute college of physiotherapy |
| Address |
Sancheti Healthcare Academy ,
Sancheti Institute College of Physiotherapy ,
11/12 thube park , shivajinagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Kanchan Musmade |
Tertiary Healthcare Center in Pune (Orthopaedic Out Patient Department) |
Sancheti Institute of Orthopaedics and Rehabilitation,
11/12 Thube Park,
16, Shivajinagar,
Pune - 411005
Maharashtra, India
Pune
MAHARASHTRA |
8237015624
kanchanmusmade24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Sancheti Institute for Orthopaedics and Rehabilitation,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Low Back Pain with Radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Butlers neural tissue mobilisation group |
SLR positive- Structural differentiation will be done to see if the symptoms are purely neural or due to other structures. Only if the SLR is positive the following sequence is followed.
Technique: The patient’s limb would be taken into SLR till a point where symptoms would be reproduced.. The knee will be extended and hip flexed in one plane and the leg will be taken to the point where symptoms were reproduced. Slow oscillations or sustained stretch will be given by the therapist for 10 s depending on the grade of mobilization (Maitland grade 3 and 4) after which the leg was returned to a non-painful position.
Dosages: 20 to 30 seconds for 3 sets , 6 sessions for 2 weeks
Conventional therapy Hydrocollateral pack for 10 minutes for 6 sessions under supervision Common exercise protocol: 1) Core strengthening exercises The therapist will palpate the local muscles to confirm their recruitment for bilateral activation of multifidus with transverses abdominis activation, with controlled breathing. 2) DIRECTION SPECIFIC EXERCISES FLEXION OR EXTENSION BIAS EXERCISES |
| Intervention |
SHACKLOCKS NEURAL TISUUE MOBILISATION GROUP |
SLR positive -
Structural differentiation will be done to see if the symptoms are purely neural or due to other structures.
Only if the SLR is positive the following sequence is followed
- REMOTE SEQUENCE, REMOTE SLIDERS; sliders using unaffected joints and affected area in neutral position
- STANDARD SEQUENCE, LOCAL SLIDERS; without or with minimal symptoms
- STANDARD SEQUENCE, (ONE ENDED)TENSIONERS; without or with minimal symptoms
Dosages: 30- 2 min (approximately 10 repetitions) for 5 sets , 6 sessions for 2 weeks
Conventional therapy
Hydrocollateral pack for 10 minutes for 6 sessions under supervision
Common exercise protocol:
1) Core strengthening exercises
The therapist will palpate the local muscles to confirm their recruitment for bilateral activation of multifidus with transverses abdominis activation, with controlled breathing.
2) DIRECTION SPECIFIC EXERCISES
FLEXION OR EXTENSION BIAS EXERCISES |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Diagnosed cases of unilateral lumbar radiculopathy
-Subjects with straight leg raising test positive.
-NRS score 4 to 7 (moderate pain). |
|
| ExclusionCriteria |
| Details |
•Mechanical low back pain
•Any lumbar spine fracture
•Back strain
•Bilateral Lumbar Radiculopathy
•Any Spinal Surgery in last 1 year
•Lumbar radiculopathy associated with neurological deficits
•Pregnancy
•Malignancy
•Lumbar myelopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)PAIN-Numerical rating Scale
2)ROM-Hip flexion angle in SLR position
3)BACK FUNCTION-Sciatica Bothersome Index
-Oswestry disability index
|
-baseline
-post intervention after 2
weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)PAIN-Numerical rating Scale
2)ROM-Hip flexion angle in SLR position
3)BACK FUNCTION-Sciatica Bothersome Index
-Oswestry disability index
|
-baseline
-post intervention after 2
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)
|
10/04/2017 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
-AIM: To compare the effectiveness of Butler’s and Shacklock’s technique of neural tissue mobilisation on pain and disability in patients with unilateral lower limb radiculopathy -OBJECTIVES: 1) To study the effectiveness of Butler’s technique of neural tissue mobilisation on pain and disability in patients with unilateral lower limb radiculopathy 2) To study the effect of Shacklock’s technique of neural tissue mobilisation on pain and disability in patients with unilateral lower limb radiculopathy 3) To compare the effectiveness of Butler’s and Shacklock’s technique of neural tissue mobilization on pain and disability in patients with unilateral lower limb radiculopathy -RESEARCH QUESTION: Which of the two techniques of neural tissue mobilisation are more effective on pain and disability in patients of unilateral lower limb radiculopathy: Butler or Shacklock? -HYPOTHESIS: A significant difference exists between the effectiveness of both the techniques of neural tissue mobilisation in patients with unilateral lower limb radiculopathy -NULL HYPOTHESIS: There is no significant difference between the effectiveness of both the techniques of neural tissue mobilization in patients with unilateral lower limb radiculopathy |