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Clinical Trials/CTRI/2024/12/077957
CTRI/2024/12/077957
Not yet recruiting
Not Applicable

Effect of lumbopelvic-hip stability exercises on pain, physical performance and self-efficacy in patients with chronic nonspecific low back pain- a randomized controlled trial

Pravin Gawali2 sites in 1 country106 target enrollmentStarted: December 16, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Pravin Gawali
Enrollment
106
Locations
2
Primary Endpoint
Pain-NPRS

Overview

Brief Summary

A randomized controlled trial will be conducted as per the guidelines/statement given by CONSORT 2010 (Consolidated Standards of Reporting Trials).

The research will be carried out as per the approval of the head of the institutes and Institutional Ethical Committee. The study protocol will be conducted according to the declaration of Helsinki.

Evaluation of the participant will be done at the baseline on first day, using NPRS for low back pain intensity, Physical Performance by One Minute Sit to Stand Test and Timed up and go test, Self-Efficacy by Pain Self Efficacy Questionnaire (PSEQ) and assessment will be documented accordingly. Re-assessment using same outcome measures will be done after completion of treatment protocol of 6-weeks for both the groups.

The study will be blinded by assigning the experienced Physiotherapy colleague with experience of more than 15 years for the assessment of the subject at the time of recruitment and on completion of the treatment protocol after six weeks.

This study will have two experimental group, Random allocation of subjects who meet inclusion criteria and give consent for the study will be allocated to either of the two groups. Group A and Group B by table of random sequence generation generated by computer online. Group A will receive Lumbopelvic stability exercises and Group B will receive lumbo-pelvic exercises with the addition of hip joint stability exercises.

All the exercises will focus on retraining motor control a core muscles with addition of hip joint local and global stabilizers.

Assessment of the faulty posture and faulty movement patterns, and importance of exercise program will be explained on first session.

Two sessions per week will be given followed by home exercise program for six weeks.

The treatment protocol will be participant specific and progression will be made according to the participant’s performance.

Any drop-outs or participants lost to follow-up will be mentioned with appropriate reasoning.

At the end of the study the data will be collected, coded and tabulated using descriptive and inferential statistics. All analysis will be done using SPSS for Windows.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • A reported minimum score of 5 and more than 5 out of 10 on NPRS.
  • Location of pain: Below the costal margin and above the gluteal folds With or without somatic referred (Dull aching) pain in the leg.
  • NSLBP referred by an orthopedic surgeon for physiotherapy.

Exclusion Criteria

  • Radicular Pain -sharp shooting in dermatomal pattern.
  • History of spinal surgery, History of ankylosing spondylitis or rheumatoid arthritis, History of spondylolisthesis or spondylolysis, History of spinal or pelvic fracture, History of spinal inflammation or tumor, History of osteoporosis, Continuous use of pain medications History of stroke, History of respiratory disease or heart disease, or Pregnancy.

Outcomes

Primary Outcomes

Pain-NPRS

Time Frame: at baseline and after six weeks.

Physical Performance-

Time Frame: at baseline and after six weeks.

One Minute sit to stand

Time Frame: at baseline and after six weeks.

Timed up and go test

Time Frame: at baseline and after six weeks.

Self Efficacy-

Time Frame: at baseline and after six weeks.

Pain Self Efficacy Questionnaire

Time Frame: at baseline and after six weeks.

Secondary Outcomes

  • N/A(N/A)

Investigators

Sponsor
Pravin Gawali
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Bhavana Mhatre

Physiotherapy School and centre, Seth G.S. Medical college and KEM Hospital

Study Sites (2)

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