Core Stability Exercises With Surface Electromyography Biofeedback in Patients With Mechanical Low Back Pain
Primary Purpose
Low Back Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Core stability exercises
Biofeedback training
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Postural stability, Sensory integration of balance, Surface Electromyography Biofeedback
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders with mechanical low back pain
- Patients with Lumbar Derangement Syndrome. (Mckenzie Classification)
- Age: 18 to 60 years
- Patients of both gender
- NPRS ratings greater than 5
- Constant or Intermittent pain worsening on repeated movements -
Exclusion Criteria:
- Patients with non-mechanical low back pain
- Patients with acute low back pain.
- Post laminectomy/discectomy
- Spondylolisthesis
- Osteoporosis/Fractures
- Cauda equine syndrome
- Recent history of spinal trauma or surgery
- Lumbar myelopathy
- Patients with known metabolic diseases
- Patients with any neurological deficit
- Patients with any vestibular problems 12 Patients with visual impairment -
Sites / Locations
- Foundation University Islamabad
- Riphah University Lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Core stability protocol
Core Stability with surface electromyography biofeedback
Arm Description
Participants in this group will undergo core stability exercise program . Each exercise plan will be progressively increased.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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).
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)
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
Full Information
NCT ID
NCT05425121
First Posted
June 15, 2022
Last Updated
June 15, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05425121
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Postural stability, Sensory integration of balance, Surface Electromyography Biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Core stability protocol
Arm Type
Active Comparator
Arm Description
Participants in this group will undergo core stability exercise program . Each exercise plan will be progressively increased.
Arm Title
Core Stability with surface electromyography biofeedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Core stability exercises
Intervention Description
The intervention in the control group will core stability exercises for different back muscles and strengthening exercises of Gluteal Muscles.
Intervention Type
Device
Intervention Name(s)
Biofeedback training
Intervention Description
EMG biofeedback training will be administered to the participants in combination with core stability exercise training.
Primary Outcome Measure Information:
Title
Postural Stability
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Sensory integration of Balance
Description
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
Time Frame
6 weeks
Title
Low Back Pain
Description
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).
Time Frame
6 weeks
Title
Low back related functional disability
Description
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)
Time Frame
6 weeks
Title
Lumbar Range of Motion
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both genders with mechanical low back pain
Patients with Lumbar Derangement Syndrome. (Mckenzie Classification)
Age: 18 to 60 years
Patients of both gender
NPRS ratings greater than 5
Constant or Intermittent pain worsening on repeated movements -
Exclusion Criteria:
Patients with non-mechanical low back pain
Patients with acute low back pain.
Post laminectomy/discectomy
Spondylolisthesis
Osteoporosis/Fractures
Cauda equine syndrome
Recent history of spinal trauma or surgery
Lumbar myelopathy
Patients with known metabolic diseases
Patients with any neurological deficit
Patients with any vestibular problems 12 Patients with visual impairment -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Furqan Yaqoob, Phd*
Phone
03113331717
Email
furqan.yaqoob@fui.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Rabiya Noor, Phd
Organizational Affiliation
Riphah University Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Islamabad
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Furqan Yaqoob, Phd*
Phone
03465333101
Email
furqan.yaqoob@fui.edu.pk
First Name & Middle Initial & Last Name & Degree
Muhammad Furqan Yaqoob, PhD*
Facility Name
Riphah University Lahore
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, Phd
Phone
03344355660
Email
rabiya.noor@riphah.edu.pk
12. IPD Sharing Statement
Plan to Share IPD
No
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Core Stability Exercises With Surface Electromyography Biofeedback in Patients With Mechanical Low Back Pain
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