| CTRI Number |
CTRI/2024/07/070911 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study between the effects of Thoracic mobilization and neural mobilization on pain, range of motion and function in patients having low back pain with radiation to lower limb |
|
Scientific Title of Study
|
Comparison between Thoracic Mobilization and Neural Mobilization on Pain, Range of motion and Function in Lumbar Radiculopathy: A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chanchal Sah |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute For Locomotor Disabilities(Divyangjan) |
| Address |
Room number 117, Department of Physiotherapy, National Institute For Locomotor Disabilities(Divyangjan), BT Road, Bonhooghly,Kolkata,North Twentyfour Paragnas, West Bengal,700090,India
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
7685034460 |
| Fax |
|
| Email |
chanchalsah26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Patralika Nath |
| Designation |
Lectuter |
| Affiliation |
National Institute For Locomotor Disabilities(Divyangjan) |
| Address |
Room number 117, Department of Physiotherapy, National Institute For Locomotor Disabilities(Divyangjan), BT Road, Bonhooghly,Kolkata,North Twentyfour Paragnas, West Bengal,700090,India
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9874540980 |
| Fax |
|
| Email |
ptranth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chanchal Sah |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute For Locomotor Disabilities(Divyangjan) |
| Address |
Room number 117, Department of Physiotherapy, National Institute For Locomotor Disabilities(Divyangjan), BT Road, Bonhooghly,Kolkata,North Twentyfour Paragnas, West Bengal,700090,India
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
7685034460 |
| Fax |
|
| Email |
chanchalsah26@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute for locomotor Disabilities (Divyangjan) BT Road, Bonhoogly, Kolkata, West Bengal Pin Code 700090 |
|
|
Primary Sponsor
|
| Name |
Chanchal Sah |
| Address |
Room number 117,Department of Physiotherapy, National Institute For Locomotor Disabilities(Divyangjan),BT Road, Bonhooghly,kolkata, West Bengal,Pincode-700090. North Twentyfour Paragnas,West Bengal
India |
| 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 |
| Chanchal Sah |
National Institute For Locomotor Disabilities(Divyangjan) |
Room number 117, Department of Physiotherapy, National Institute For Locomotor Disabilities (Divyangjan),BT Road,Bonhooghly,Kolkata,West Bengal-700090,North Twentyfour Paragnas
India
North Twentyfour Parganas
WEST BENGAL |
7685034460
chanchalsah26@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute For Locomotor Disabilities( Divyangjan) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M541||Radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neural Mobilization |
All the patient in this group will be treated by Neural Mobilization along with Moist Hot Pack, Supervised Exercises and HEP. Treatment will be given with dorsiflexion oscillations for five sets (5- 10times/set) with one to two minutes rest in between sets for 10 sessions. |
| Intervention |
Thoracic Mobilization |
All the patient in this group will be treated by Thoracic Mobilization along with Moist Hot Pack, Supervised Exercises and HEP. Treatment will be given with 30 oscillatory movements to each segment from T1 to T12 segment for 10 sessions. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female patients.
2.Patients age between 35 and 60 years.[2]
3.Patients complaining of Low Back Pain radiating to posterior leg in unilateral limb.
4.Pain duration of more than 3 months.
5.Pain intensity according to Visual Analogue Scale (VAS) 3cm to 8cm.
6.Any two of the following special tests should be positive:
a.Slump Test
b.Straight leg raising test (Sciatic nerve bias)
c.Sitting Root Test
|
|
| ExclusionCriteria |
| Details |
1.Musculoskeletal disorders like Fibromyalgia, Piriformis syndrome, history of fracture/surgery of spine or lower limb etc.
2.Red flag signs such as diagnosed cases of carcinoma, tumor, and infectious disease of spine like Tuberculosis etc.
3.Rheumatological disorders like Ankylosing spondylitis, Rheumatoid arthritis etc.
4.Neurological disorders like Cerebro-Vascular Accident, Spinal cord injury, any neurological deficit etc and congenital pathology such as Scoliosis, Spina Bifida etc.
5.Pregnancy.
6.Non-cooperative patients.
7.Sensory deficit/ Anaesthesia in back region.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain by VAS
2.ROM by MMST
3.Function by ODI
|
2 times - Before intervention and after 10th session of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
PURPOSE OF THE STUDY:
There are various
studies available which shows that Thoracic Mobilization and Neural
Mobilization are effective in Lumbar Radiculopathy. However, to the best of our
knowledge there are no studies available which compare the efficacy of Thoracic
Mobilization and Neural Mobilization on Pain, Range of Motion and Function in
Lumbar Radiculopathy. So the purpose of the study is to compare between Thoracic Mobilization and Neural Mobilization on Pain, ROM and Function in Lumbar Radiculopathy.
AIM:
To compare between Thoracic
Mobilization and Neural Mobilization on Pain, Range of Motion and Function in
Lumbar Radiculopathy.
OBJECTIVES:
1. To
find out the efficacy of Thoracic Mobilization along with Moist Hot Pack and
Supervised Exercises on Pain, Range of Motion & Function in Lumbar Radiculopathy. 2. To
find out the efficacy of Neural Mobilization along with Moist Hot Pack and
Supervised Exercises on Pain, Range of Motion & Function in Lumbar
Radiculopathy. 3. To compare between Thoracic Mobilization and
Neural Mobilization on Pain, Range of Motion and Function in Lumbar Radiculopathy.
HYPOTHESES:
NULL HYPOTHESIS (H0): There
is no statistically significant difference between the efficacy of Thoracic
Mobilization and Neural Mobilization on Pain, Range of Motion and Function in
Lumbar Radiculopathy. ALTERNATIVE HYPOTHESIS (H1):
There is statistically
significant difference between the efficacy of Thoracic Mobilization and Neural
Mobilization on Pain, Range of Motion and Function in Lumbar Radiculopathy.
PROCEDURE:
Approval from the
Institutional Ethical Committee (IEC) will be taken before commencement of the
study. All the patients complaining of Low Back Pain radiating to posterior leg
or diagnosed with Lumbar Radiculopathy referred from the Assessment Clinic of
National Institute for Locomotor Disabilities (Divyangjan) will be assessed and
screened according to inclusion and exclusion criteria. Patients meeting the
exclusion criteria will not be included. Those fulfilling the inclusion
criteria will be explained in detail about the study in their most preferable
language. Written informed consent in their preferred language will be obtained
from the patients agreeing to participate. Then patients will be divided into
two groups with a minimum of 16 patients in each group, by Block Randomization
method from computer generated random blocks. In Group-A (n=16)
Thoracic Mobilization along with Moist Hot Pack & Supervised Exercises for
10 sessions, in Group- B (n=16) Neural Mobilization along with Moist Hot Pack &
Supervised Exercises for 10 sessions will be given. Home exercise program and
Ergonomic care will be explained to all the patients in both groups.
The demographic
data and the baseline data for Pain using ‘Visual Analogue Scale’, Range of
Motion using ‘Modified Modified Schober test’
and Function using ‘Oswestry Disability Index’ will be collected from each
patient before providing interventions, and at the end of 10th session. Rescue
medication duly prescribed by physician will be continued along with the
Physiotherapeutic approach in both the group during the study.
|