| CTRI Number |
CTRI/2018/04/013056 [Registered on: 05/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/03/2018 |
| 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
|
Effect of Backward Walking on Treadmill in patients with Low Back Pain |
|
Scientific Title of Study
|
Effect of Backward Walking In addition To Conventional Therapy On Back Function In patients With Mechanical Low Back Pain |
| Trial Acronym |
BWLBP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Kawediya |
| Designation |
PG Student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Healthcare Academy,
Sancheti Institute College of Physiotherapy
11/12 Thube Park, Shivajinagar,
Pune-411005
Pune MAHARASHTRA 411005 India |
| Phone |
9049121678 |
| Fax |
|
| Email |
diya.0512@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sona Kolke |
| Designation |
Associate Professor |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Healthcare Academy,
Sancheti Institute College of Physiotherapy
11/12 Thube Park, Shivajinagar,
Pune-411005
Pune MAHARASHTRA 411005 India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Divya Kawediya |
| Designation |
PG Student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Healthcare Academy,
Sancheti Institute College of Physiotherapy
11/12 Thube Park, Shivajinagar,
Pune-411005
Pune MAHARASHTRA 411005 India |
| Phone |
9049121678 |
| Fax |
|
| Email |
diya.0512@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Healthcare Academy
Sancheti Institute College of Physiotherapy
11/12, Thube park
Shivajinagar
Pune 411005 |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Healthcare Academy,
Sancheti Institute College of Physiotherapy
11/12 Thube Park, Shivajinagar,
Pune-411005 |
| 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 |
| Divya Kawediya |
Sancheti Institute for Orthopedics and Rehabilitation |
Sancheti Institute for Orthopedics and Rehabilitation,
Physiotherapy Department,
Sports Medicine Centre,
16, Shivaji Nagar, Pune 411005 Pune MAHARASHTRA |
9049121678
diya.0512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board - Sancheti Institute for Orthopedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Mechanical Low Back Pain patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group (Conventional Therapy Group) |
Postural education, Hydro Collator Packs, Stretching exercises for DLF, Hamstrings, iliopsoas, Piriformis. Pelvic stabilization exercises (bridging, cat and camel, pelvic tilts, core activation in crook lying, prone on hands or elbows)
Total of 8 sessions in 2 weeks duration |
| Intervention |
Experimental group (Backwards walking group) |
Postural education, Hydro Collator Packs, Stretching exercises for DLF, Hamstrings, iliopsoas, Piriformis. Pelvic stabilization exercises (bridging, cat and camel, pelvic tilts, core activation in crook lying, prone on hands or elbows)
Treadmill backward walking for 15 mins (no inclination, self controlled speed)
Total of 8 sessions in 2 weeks duration |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
VAS 4-7 (moderate intensity) |
|
| ExclusionCriteria |
| Details |
Lower extremity soft tissue injuries in last 6 months.
- Lower extremity fractures in last 1 year.
- Spinal surgery in last 3 years.
- Balance impairments.
- Spinal tumour or infection, spinal instability, spondylolisthesis, spinal canal stenosis, lumbar radiculopathy, discogenic back pain, SI joint dysfunction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain - Visual Analogue Scale (VAS)
Low back ROM - sagittal and coronal plane ROM (i.e lumbar flexion, extension and side flexion) – Dual Inclinometer
Back Function – Modified Oswestry Low Back Pain Disability Questionnaire (Modified ODQ |
Baseline
Immediately after 2 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2016 |
| Date of Study Completion (India) |
21/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="7" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: Mechanical low back pain (LBP) is one of the major cause of illness and disability, especially in people of working age, in which there is deformation of structures containing nociceptive nerve endings and having direct correlation between certain body positions and the patient’s symptoms. Individuals with mechanical low back pain usually present with limited low back range of motion (ROM) and reduced flexibility thus resulting in limitation in their function. Aim of most of the therapeutic interventions for mechanical back pain is to achieve pain relief, adequate flexibility and improve ROM of the spine. NEED FOR STUDY The source of symptoms in mechanical LBP is not completely understood. This increases the complexity of the diagnosis and also poses as a challenge for treatment of mechanical LBP. The current treatment techniques employed by physical therapists to manage mechanical LBP include various electrotherapeutic modalities, thermotherapy, mobilizations, manipulations, stretching, orthotics, posture correction, ergonomics followed by introduction of light exercises[10, 25-29]. Beyond the success of these physical therapy interventions there is still a lack of integrated treatment modalities for further progression. Backward walking can possibly bridge this gap and thus help in improving function in patients with mechanical low back pain. Despite the above findings backward walking, has not received a thorough scientific analysis with respect to its effectiveness in reducing pain and improving function and low back ROM in patients with mechanical LBP. Therefore, in this study we intend to examine whether treadmill backward walking in addition to conventional therapy can reduce low back pain and improve overall back function in patients with mechanical LBP. AIMS AND OBJECTIVES AIM To study the effect of backward walking in addition to conventional therapy on pain, low back ROM and overall back function in patients with mechanical low back pain. OBJECTIVES The objectives of this study are to examine the following in patients with mechanical LBP: 1) the effectiveness of backward walking i.e Experimental group on pain intensity, low back ROM (coronal and sagittal plane) and overall back function 2) the effectiveness of conventional therapy i.e Control group on pain intensity, low back ROM and overall back function 3) to compare the findings of both the groups.
RESEARCH QUESTION Does treadmill backward walking have an additional effect on pain, low back ROM and overall back function in patients with mechanical low back pain? HYPOTHESIS AND NULL HYPOTHESIS HYPOTHESIS Treadmill backward walking intervention in addition to conventional therapy will have a beneficial effect on overall back function in patients with mechanical LBP. NULL HYPOTHESIS Treadmill backward walking intervention along with conventional therapy will not have any additional effect on overall back function in patients with mechanical LBP.
RESULTS The results of this study indicate that backward walking along with conventional therapy has shown statistically significant reduction in LBP and improvement in back function as compared to conventional therapy alone.
CONCLUSION The present study concluded that -Backward walking is effective in relieving pain, improving function and increasing low back ROM in patients with mechanical low back pain. -Conventional therapy is effective in relieving pain, improving function and increasing low back ROM in patients with mechanical low back pain. -However, treadmill backward walking in addition to conventional therapy has shown better effects than conventional therapy alone in alleviating pain and improving overall back function in patients with mechanical low back pain. |