| CTRI Number |
CTRI/2019/06/019613 [Registered on: 11/06/2019] Trial Registered Prospectively |
| Last Modified On: |
22/06/2020 |
| 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
|
Effect of backward walking on pain, flexibility,endurance and balance in college level athletes suffering from mechanical low back pain. |
|
Scientific Title of Study
|
Effect of retrowalking on pain, range of motion, muscle fatigability and balance in collegiate athletes with mechanical low back pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Md Shahid Raza PT |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no. 106, Centre for Physiotherapy and Rehabilitation sciences, Jamia Millia Islamia,Maulana Mohammed Ali Jauhar Marg, Jamia Nagar, Okhla New Delhi
South
DELHI
110025
India |
| Phone |
9212156165 |
| Fax |
|
| Email |
mraza1@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Shahid Raza PT |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no. 106, Centre for Physiotherapy and Rehabilitation sciences, Jamia Millia Islamia,Maulana Mohammed Ali Jauhar Marg, Jamia Nagar, Okhla New Delhi
South
DELHI
110025
India |
| Phone |
9212156165 |
| Fax |
|
| Email |
mraza1@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sumbul Ansari |
| Designation |
Research Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no. 106, Centre for Physiotherapy and Rehabilitation sciences, Jamia Millia Islamia,Maulana Mohammed Ali Jauhar Marg, Jamia Nagar, Okhla New Delhi
South
DELHI
110025
India |
| Phone |
8285234492 |
| Fax |
|
| Email |
sumbulansari3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation sciences, Jamia Millia Islamia. |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation sciences Jamia Millia Islamia |
| Address |
Director, Centre for Physiotherapy and Rehabilitation sciences, Jamia Millia Islamia,Maulana Mohammed Ali Jauhar Marg, Jamia Nagar, Okhla New Delhi |
| Type of Sponsor |
Other [Central University] |
|
|
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 |
| Dr Md Shahid Raza PT |
Jamia Millia Islamia |
Centre for Physiotherapy and Rehabilitation sciences, Jamia Millia Islamia,Maulana Mohammed Ali Jauhar Marg, Jamia Nagar, Okhla New Delhi
New Delhi
DELHI |
9212156165
mraza1@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Exercises Only |
The conventional exercises for low back pain includes prone trunk extension, prone leg extension, alternate prone arm and leg raise, bird dog, supine bridging,supine bridge with leg raise.these exercises will be done for 3 days per week for 4 weeks. 2 sets of 12 reps of each exercise with a hold of 10 seconds and a rest interval of 1 minute between the sets. |
| Intervention |
Retrowalking plus Conventional exercises |
Backward walking on a treadmill at self paced speed for 15 minutes for 3 days per week for 4 weeks plus the conventional exercises for low back pain includes prone trunk extension, prone leg extension, alternate prone arm and leg raise, bird dog, supine bridging,supine bridge with leg raise.these exercises will be done for 3 days per week for 4 weeks. 2 sets of 12 reps of each exercise with a hold of 10 seconds and a rest interval of 1 minute between the sets. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Collegiate athletes with mechanical low back pain, gender: male/ female, age: 18 – 30 years, no radicular symptoms such as radiating pain below knee, loss of sensation, low back pain duration : <12 weeks (3 months), Oswestry Disability Index score : 20 to 60%
|
|
| ExclusionCriteria |
| Details |
Recent trauma leading to body pain and postural deformities, any previous surgery leading to body pain and postural deformities, Congenital Postural Deformities, Subjects with T.B. or any malignancy or major illness affecting musculoskeletal system, Systemic inflammatory disorders, Current pregnancy, Symptoms of nerve root compression (i.e., pain distal to the knee), Spondylolisthesis, Spinal stenosis, Inflammatory disease and cancer, Metabolic or vascular disease with a neurological component such as diabetes or atherosclerosis. |
|
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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 |
Pain
Flexion range of motion of the lower back
Muscle fatigability
Balance |
Before the starting of the intervention (baseline) and after the completion of 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2019 |
| Date of Study Completion (India) |
15/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/09/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
· Objective of the study: To find the effect of retrowalking on pain, flexion range of motion of the lower back, muscle fatigability and baalnce in collegaite athletes suffering from mechanical low back pain.
Significance of the study: This study will help us to determine if retrowalking can be incorporated in the treatment of athletes suffering from mechanical low back pain and/or if retrowalking has any additional effects in conjunction with conventional physiotherapy exercises. Study Design: comparative pre-test post-test experimental study design will be used in this study. Methodology: 30 collegiate athletes suffering from mechanical low back ache will be recruited based on the inclusion and exclusion criteria. the subjects will be randomly assigned to groupA (retrowalking plus conventional exercise) or group B(conventional exercise only). Outcome measures that is, pain , range of motion, muscle fatigability will be recorded before the start of the intervention and after the completion of 4 weeks of intervention.Subjects in both the groups will receive their respective treatments for 3 days per week for 4 weeks. Familiarization sessions will be provided beforehand. informed consent will be signed by the subject before participation in the study, all identifying information of the participant will be kept confidential.
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