Clinical trial NCT05425121: Core Stability Exercises With Surface Electromyography Biofeedback in Patients With Mechanical Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Postural stability
Sensory integration of balance
Surface Electromyography Biofeedback
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to control Group A (Core stability training protocol ) or Interventional Group B(core stability training protocol with surface electromyography biofeedback protocol) for the whole duration of the study.
Primary purpose: TREATMENT

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

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 outcomes:
measure: Postural Stability
timeFrame: 6 weeks
Secondary outcomes:
measure: Sensory integration of Balance
timeFrame: 6 weeks
measure: Low Back Pain
timeFrame: 6 weeks
measure: Low back related functional disability
timeFrame: 6 weeks
measure: Lumbar Range of Motion
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Islamabad
state: Punjab
city: Lahore
country: Pakistan
facility: Riphah University Lahore
state: Punjab
Study officials:
affiliation: Riphah University Lahore
name: Dr Rabiya Noor, Phd
role: PRINCIPAL_INVESTIGATOR
References: