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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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