NCT05044702

Brief Summary

Chronic low back pain (CLBP) is a clinical entity that can be defined as back pain with duration of more than 12 weeks. Chronic low back pain is associated with restriction in daily physical activities that ultimately leads to disuse atrophy of muscles. Moreover, weak and atrophied muscles around the lumbar spine cause immense immobility and recurring low back pain in these patients. The objective of this study will be to determine the effect of retro walking on pain, physical function and flexibility in chronic non-specific low back pain. This study will be a randomized controlled trial and will be conducted in physiotherapy department in DHQ hospital Nankana Sahib. The study will be completed in time duration of six months after the approval of synopsis and consecutive sampling technique will be used. 40 subjects will be divided in two groups. Group A will follow retro walking and conventional treatment while group B will follow only conventional treatment. Data will be collected by all participants before 1st session after 6th session and at the end of 12th session by using NPRS, MODI, sit and reach test and Modified schobber's test. Data will be analyzed by SPSS-25.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

September 13, 2021

Last Update Submit

April 4, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • • Numeric Pain Rating Scale (NPRS)

    NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

    4 weeks

  • MODIFIED OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE

    The MODI has been developed to assess pain related disability. The questionnaire consists of 10 items addressing different aspects of function. Each item is scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage

    4 weeks

Secondary Outcomes (2)

  • MODIFIED SCHOBER TEST

    4 weeks

  • SIT-AND-REACH TEST

    4 weeks

Study Arms (2)

Retro walking

EXPERIMENTAL

Retro walking

Other: Retro walkingOther: conventional physical therapy

conventional physical therapy

ACTIVE COMPARATOR

Conventional Physical therapy

Other: conventional physical therapy

Interventions

Retro walking will be performed on treadmill for 15 min per day for 3 days per week for 4 weeks at self-paced speed.

Retro walking

hot pack for 10 mints and conventional exercise program Conventional physiotherapeutic exercise program which consist of exercises such as * prone leg extension * prone lying chest elevation * prone extension with alternate arm and leg lift * supine bridging, bridging with one leg lift Each exercise will be performed as 2 sets of 12 repetitions of each exercise, each exercise position maintained for 10 s, and a rest of 1 min between the sets will be perform. No external load/resistance will be provided for the exercises, and the participants will be perform the exercise within their available range of motion

Retro walkingconventional physical therapy

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age:25-45yrs
  • LBP for\>12 weeks
  • those having mild-to-moderate disability
  • An ODI score ranging from 20 to 60%
  • Being able to walk independently with or without walking aids
  • Being able to understand and follow instructions on testing procedures.

You may not qualify if:

  • Any recent trauma leading to body pain and postural deformities
  • Any previous surgery leading to body pain and postural deformities,
  • congenital postural deformities,
  • current pregnancy,
  • Nerve root compression (determined by the presence of two or more of the symptoms-weakness of myotomes, sensory loss of dermatomes, and hyporefexia),
  • sacroiliac joint dysfunction (determined by any three positives among distraction test, gaenslen's test, thigh thrust test, sacral thrust test, and compression test),
  • any metabolic or vascular disease with a neurological component such as atherosclerosis
  • Any contraindication to physiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical therapy Center in DHQ hospital

Nankana Sahib, Punjab Province, Pakistan

Location

Related Publications (7)

  • Smeets RJ, Wade D, Hidding A, Van Leeuwen PJ, Vlaeyen JW, Knottnerus JA. The association of physical deconditioning and chronic low back pain: a hypothesis-oriented systematic review. Disabil Rehabil. 2006 Jun 15;28(11):673-93. doi: 10.1080/09638280500264782.

    PMID: 16809211BACKGROUND
  • Chatzitheodorou D, Kabitsis C, Malliou P, Mougios V. A pilot study of the effects of high-intensity aerobic exercise versus passive interventions on pain, disability, psychological strain, and serum cortisol concentrations in people with chronic low back pain. Phys Ther. 2007 Mar;87(3):304-12. doi: 10.2522/ptj.20060080. Epub 2007 Feb 6.

    PMID: 17284546BACKGROUND
  • Hoogkamer W, Meyns P, Duysens J. Steps forward in understanding backward gait: from basic circuits to rehabilitation. Exerc Sport Sci Rev. 2014 Jan;42(1):23-9. doi: 10.1249/JES.0000000000000000.

    PMID: 24188982BACKGROUND
  • Viggiano D, Travaglio M, Cacciola G, Di Costanzo A. Effect of backward walking on attention: possible application on ADHD. Transl Med UniSa. 2014 Dec 19;11:48-54. eCollection 2015 Jan-Apr.

    PMID: 25674550BACKGROUND
  • Ansari B, Bhati P, Singla D, Nazish N, Hussain ME. Lumbar Muscle Activation Pattern During Forward and Backward Walking in Participants With and Without Chronic Low Back Pain: An Electromyographic Study. J Chiropr Med. 2018 Dec;17(4):217-225. doi: 10.1016/j.jcm.2018.03.008. Epub 2019 Jan 20.

    PMID: 30846913BACKGROUND
  • Tousignant M, Poulin L, Marchand S, Viau A, Place C. The Modified-Modified Schober Test for range of motion assessment of lumbar flexion in patients with low back pain: a study of criterion validity, intra- and inter-rater reliability and minimum metrically detectable change. Disabil Rehabil. 2005 May 20;27(10):553-9. doi: 10.1080/09638280400018411.

    PMID: 16019864BACKGROUND
  • Lopez-Minarro PA, Andujar PS, Rodrnguez-Garcna PL. A comparison of the sit-and-reach test and the back-saver sit-and-reach test in university students. J Sports Sci Med. 2009 Mar 1;8(1):116-22. eCollection 2009.

    PMID: 24150564BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saima Zahid, PhD*

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 16, 2021

Study Start

September 15, 2021

Primary Completion

March 15, 2022

Study Completion

March 25, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations