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

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

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Core stability exercises; Device: Biofeedback training

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

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Furqan Yaqoob, Phd*; Phone Number: 03113331717; Email: furqan.yaqoob@fui.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Islamabad, Punjab, Pakistan, 46000
      • Foundation University Islamabad
      • Contact: Muhammad Furqan Yaqoob, Phd*; Phone Number: 03465333101; Email: furqan.yaqoob@fui.edu.pk
      • Principal Investigator: Muhammad Furqan Yaqoob, PhD*
    • Lahore, Punjab, Pakistan
      • Riphah University Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Core stability protocol; Participants in this group will undergo core stability exercise program . Each exercise plan will be progressively increased.	Procedure: Core stability exercises; The intervention in the control group will core stability exercises for different back muscles and strengthening exercises of Gluteal Muscles.
EXPERIMENTAL: 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.	Procedure: Core stability exercises; The intervention in the control group will core stability exercises for different back muscles and strengthening exercises of Gluteal Muscles.; Device: Biofeedback training; EMG biofeedback training will be administered to the participants in combination with core stability exercise training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural Stability	it will be measured by using postural stability Balance System (R=0.94) (WJC Cachupe et al, 2001). This test is performed with open eyes as well as eyes closed and overall stability index will be calculated at the end of the test along with the percentage of time spent in each of the quadrants and zones (A to D).This test also provided information about the anterior /posterior index and Medial/Lateral index of participation	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory integration of Balance	The Clinical Test of Sensory Interaction and Balance CTSIB is an accepted test protocol for sensory component of Balance assessment on a static surface. The CTSIB test protocol was selected for Fall Risk assessment as it is well documented in the literature as an effective test in identifying individuals with mild to severe balance problems Clinical test of Sensory Integration of Balance (CTSIB) using 4 different conditions using balance Balance System (R=0.94) (WJC Cachupe et al, 2001); Eyes open firm surface: Baseline: Incorporates visual, vestibular and somatosensory inputs; Eyes closed firm surface: Eliminate visual input to evaluate vestibular and somatosensory inputs.; Eyes open on a dynamic surface used to evaluate somatosensory interaction with visually input; Eyes closed on dynamic surface: used to evaluate somatosensory interaction with vestibular input	6 weeks
Low Back Pain	Numerical pain rating scale is a patient self-report scale for measurement of pain intensity in the clinical and research settings. The NPRS has reliability from 0.67-0.96 patient rate his pain on the scale of 0-10: 0 - (no pain) and 10 - (worst pain).	6 weeks
Low back related functional disability	The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. (R= 0.42 - 0.91) Macedo et al. (2011)	6 weeks
Lumbar Range of Motion	Lumbar Physiological movements including forward bending, backward bending, and Right & Left side bending measured via Bubble Inclinometer. Inter-rater and intra-rater reliability for the inclinometer with Intra-class Correlation Coefficients of 0.90 and 0.85 for lumbar	6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Dr Rabiya Noor, Phd, Riphah University Lahore

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (ACTUAL): June 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Low back pain; Postural stability; Sensory integration of balance; Surface Electromyography Biofeedback
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: REC/RCRS&AHS/22/1105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No