| CTRI Number |
CTRI/2020/06/025904 [Registered on: 16/06/2020] Trial Registered Prospectively |
| Last Modified On: |
05/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of exercises to reduce pain extending from low back to lower legs |
|
Scientific Title of Study
|
Effects of combination of neural mobilization and static hamstring stretch in lumbar 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 |
Pallavaram Aishwaryarani |
| Designation |
Master of physiotherapy (MPT) student |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Nitte institute of physiotherapy, k.s hedge medical sciences complex, nitte deemed to be university, derlakatte, mangalore, dakshina kannada, karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8019207845 |
| Fax |
|
| Email |
aishwaryarani31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Saumya srivastava |
| Designation |
Assistant professor |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Ground floor, Nitte institute of physiotherapy, k.s hedge medical sciences complex, nitte deemed to be university, derlakatte, mangalore, dakshina kannada, karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9740244077 |
| Fax |
|
| Email |
saumyasri2000@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Pallavaram Aishwaryarani |
| Designation |
Master of physiotherapy (MPT) student |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Nitte institute of physiotherapy, k.s hedge medical sciences complex, nitte deemed to be university, derlakatte, mangalore, dakshina kannada, karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8019207845 |
| Fax |
|
| Email |
aishwaryarani31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, k.s hegde hospital, derlakatte, mangalore |
|
|
Primary Sponsor
|
| Name |
Department of physiotherapy ks hegde hospital derlakatte mangalore |
| Address |
Department of physiotherapy, k.s hegde hospital, derlakatte, mangalore |
| 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 |
| Pallavaram Aishwaryarani |
Justice k.s hegde charitable hospital, mangalore |
Department of orthopaedics, 3rd floor, department of physiotherapy, justice k.s hegde charitable hospital, mangalore, dakshina kannada, karnataka
Dakshina Kannada
KARNATAKA |
8019207845
aishwaryarani31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional treatment |
Interferential therapy, hot pack, core stabilization exercises for 40 minutes.
Performed six sessions a week.
|
| Intervention |
Neural mobilization, static hamstring stretch and conventional treatment |
Neurodynamic sliders and tensioners, static hamstring stretch with conventional treatment (Interferential therapy, hot pack, core stabilization exercises) for 50 minutes, performed six session a week |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Lumbar radiculopathy patients are included with acute, subacute pain diagnosed by Orthopedician
2.VAS with 4 to 8 cm
3. Straight leg raise test– positive (30- 70 degrees)
4. Knee extension angle > 20 degrees |
|
| ExclusionCriteria |
| Details |
1.Infectious diseases
2.Spinal Cord injury
3. Obsessed patients
4. Osteoporosis
5. Pregnancy
6. Post-Operative surgery of the spine
7. Hamstring injury or surgery
8. Trauma/whiplash injury
9.Subjects with cognitive issues
10. Spinal pathological conditions like scoliosis, ankylosing spondylitis,
spinal tumors, spina bifida
11. Patients with chronic pain |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale |
six days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry disability index |
Six days |
| Active knee extension test |
Six days |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/08/2020 |
| 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="2"
Days="3" |
|
Recruitment Status of Trial (Global)
|
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
|
A combination of neural mobilization and static hamstring stretch on pain in lumbar radiculopathy is unclear. This study is to determine the combined effect of neural mobilization and static hamstring stretch on pain, disability, and flexibility in lumbar radiculopathy. |