Low Back PainNCT05425121
Core Stability Exercises With Surface Electromyography Biofeedback in Patients With Mechanical Low Back Pain
A study testing Core stability exercises and Biofeedback training in people with Low Back Pain, run by Riphah International University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Core stability exercises and Biofeedback training
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesPakistan
- Study dates
- Sep 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 -
Who cannot join
- Patients with non-mechanical low back pain
- Patients with acute low back pain.
- Post laminectomy/discectomy
- Spondylolisthesis
- Osteoporosis/Fractures
- Cauda equine syndrome
Show all 11Show fewer
- 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 -
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Foundation University Islamabad
Islamabad, Punjab Province, 46000
Muhammad Furqan Yaqoob, Phd*, 03465333101, furqan.yaqoob@fui.edu.pk
Muhammad Furqan Yaqoob, PhD*
Riphah University Lahore
Lahore, Punjab Province
Rabiya Noor, Phd, 03344355660, rabiya.noor@riphah.edu.pk
About this study
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
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 .
Read the 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
- Being tested
- Core stability exercises, Biofeedback training
- Keywords
- Low back pain, Postural stability, Sensory integration of balance, Surface Electromyography Biofeedback
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability exercisesProcedure or surgery
The intervention in the control group will core stability exercises for different back muscles and strengthening exercises of Gluteal Muscles.
Biofeedback trainingDevice
EMG biofeedback training will be administered to the participants in combination with core stability exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Core stability protocol | Active comparator | Participants in this group will undergo core stability exercise program . Each exercise plan will be progressively increased. Receives: Procedure: Core stability exercises |
| Core Stability with surface electromyography biofeedback | Experimental | 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. Receives: Procedure: Core stability exercises; Device: Biofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (4)
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
Measured: 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).
Measured: 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)
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study startSep 2022 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Rabiya Noor, Phd, Principal investigator, Riphah University Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425121
- Sponsor's protocol ID
- REC/RCRS&AHS/22/1105
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05425121
- Acronym / sponsor ID
- REC/RCRS&AHS/22/1105
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Postural stability, Sensory integration of balance, Surface Electromyography Biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Core stability protocol | Active comparator | Procedure: Core stability exercisesParticipants in this group will undergo core stability exercise program . Each exercise plan will be progressively increased. |
| Core Stability with surface electromyography biofeedback | Experimental | Procedure: Core stability exercises, Device: Biofeedback trainingParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Patients with non-mechanical low back pain
- Patients with acute low back pain.
- Post laminectomy/discectomy
- Spondylolisthesis
- Osteoporosis/Fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stability exercisesThe intervention in the control group will core stability exercises for different back muscles and strengthening exercises of Gluteal Muscles. | Procedure or surgery | Core Stability with surface electromyography biofeedback, Core stability protocol |
| Biofeedback trainingEMG biofeedback training will be administered to the participants in combination with core stability exercise training. | Device | Core Stability with surface electromyography biofeedback |
Primary outcome
Postural Stability
Time frame: 6 weeks
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
4 secondary outcomes
Sensory integration of Balance
Time frame: 6 weeks
Low Back Pain
Time frame: 6 weeks
Low back related functional disability
Time frame: 6 weeks
Lumbar Range of Motion
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Rabiya Noor, Phd principal investigator
Riphah University Lahore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability exercises and Biofeedback training in people with Low Back Pain, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Furqan Yaqoob, Phd* (03113331717, furqan.yaqoob@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Stability (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.