Core Stability Exercises With Surface Electromyography Biofeedback in Patients With Mechanical Low Back Pain

NCT ID: NCT05425121

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-12-31

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

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Core stability protocol

Participants in this group will undergo core stability exercise program . Each exercise plan will be progressively increased.

Group Type: ACTIVE_COMPARATOR

Core stability exercises

Intervention Type: PROCEDURE

The intervention in the control group will core stability exercises for different back muscles and strengthening exercises of Gluteal Muscles.

Core Stability with surface electromyography biofeedback

Participants in this group will undergo core stability exercise program with surface electromyography biofeedback. Each exercise plan will be progressively increased with application of surface electromyography biofeedback.

Group Type: EXPERIMENTAL

Core stability exercises

Intervention Type: PROCEDURE

The intervention in the control group will core stability exercises for different back muscles and strengthening exercises of Gluteal Muscles.

Biofeedback training

Intervention Type: DEVICE

EMG biofeedback training will be administered to the participants in combination with core stability exercise training.

Interventions

Core stability exercises

The intervention in the control group will core stability exercises for different back muscles and strengthening exercises of Gluteal Muscles.

Intervention Type: PROCEDURE

Biofeedback training

EMG biofeedback training will be administered to the participants in combination with core stability exercise training.

Intervention Type: DEVICE

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Rabiya Noor, Phd

Role: PRINCIPAL_INVESTIGATOR

Riphah University Lahore

Locations

Foundation University Islamabad

Islamabad, Punjab Province, Pakistan

Riphah University Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Muhammad Furqan Yaqoob, Phd*

Role: CONTACT

furqan.yaqoob@fui.edu.pk

03113331717

Facility Contacts

Muhammad Furqan Yaqoob, Phd*

Role: primary

furqan.yaqoob@fui.edu.pk

03465333101

Rabiya Noor, Phd

Role: primary

rabiya.noor@riphah.edu.pk

03344355660

Other Identifiers

REC/RCRS&AHS/22/1105

Identifier Type: -

Identifier Source: org_study_id