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ClinicalTrials.gov ID

NCT05425121

Lead Sponsor

Riphah International UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

52Estimated

Last Update Posted

Jun 21, 2022Actual

Start Date

Sep 2022Estimated

Primary Completion Date

Aug 2024Estimated

Completion Date

Dec 2024Estimated

Official Title

Effects of Core Stability Exercises With Surface Electromyography Biofeedback on Postural Stability and Sensory Integration of Balance in Patients With Mechanical Low Back Pain

Brief Summary

This study will be conducted on patients of mechanical low back pain. Surface electromyography biofeedback driven core stability protocol will be given to experimental group and the control group will be treated with core stabilization regimen. Then it will compare the effects of surface electromyography biofeedback with core stability on postural stability and sensory integration of balance .

Detailed Description

Low back pain is very common musculoskeletal condition involving lumbar spine .it is almost affecting 80 % of world's population. Mostly it is self-limiting but it is episodic in nature.it is not an isolated problem it is usually associated with social occupational stresses and psychological issues.it is significantly associated with severe disruption in functional disability morbidity. Postural control involves information processing from sensory stimuli derived from the visual, vestibular and somatosensorial systems in an integrated way to accurately regulate body positioning and center of mass movements. If one or more of these systems fail, or the sensory information is not correctly processed, the risk of a fall or instability increases. LBP can alter the sensory input to postural control ,hence leads towards lumbar instability due to weakness of core muscles in chronic low back pain it will leads to hypermobility of lumbar spine which will further adds to deterioration of internal homeostasis and motor control of lumbar spine. SEMG biofeedback can be used to help "down-train" elevated muscle activity or to "up-train" weak, inhibited, or paretic muscles.

This study will be Single blind Parallel group randomized controlled trial. The study settings will be Riphah College of Rehabilitation And Allied Health Sciences Lahore, Department of Physical Medicine and Rehabilitation Sciences, Fauji foundation Hospital Rawalpindi and Foundation University Institute of Rehabilitation Sciences. On Probability Purposive Sampling Technique will be used for sampling .A sample of 52 patients of mechanical low back pain will be obtained by using online sample calculator clincalc.com. Subjects will be randomized in to two groups i.e. Control group includes core stability exercises. Experimental group core stability with sEMG biofeedback using sealed envelope method with 1:1. In current study the assessor will be blinded from treatment allocation. The study participants satisfying the inclusion and exclusion criteria will be recruited in this trial after informed consent. Baseline assessment will be done on all participants by a Physical therapist Patients will be randomly allocated to control group (n=26), and interventional groups (n=26).Treatment will be given 3 times a week by researcher for 6 weeks with a total of 18 sessions for each patient .Re-assessment will then be done after 2nd week 4th week and at termination of treatment after 6th week

• Low Back Pain

• Core stability exercises
• Biofeedback training

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Patients of both genders with mechanical low back pain
2. Patients with Lumbar Derangement Syndrome. (Mckenzie Classification)
3. Age: 18 to 60 years
4. Patients of both gender
5. NPRS ratings greater than 5
6. Constant or Intermittent pain worsening on repeated movements -

Exclusion Criteria:

1. Patients with non-mechanical low back pain
2. Patients with acute low back pain.
3. Post laminectomy/discectomy
4. Spondylolisthesis
5. Osteoporosis/Fractures
6. Cauda equine syndrome
7. Recent history of spinal trauma or surgery
8. Lumbar myelopathy
9. Patients with known metabolic diseases
10. Patients with any neurological deficit
11. Patients with any vestibular problems 12 Patients with visual impairment -

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Riphah International UniversityOTHER

rabiya.noor@riphah.edu.pk03344355660