NCT05425121

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

June 15, 2022

Last Update Submit

June 15, 2022

Conditions

Keywords

Low back painPostural stabilitySensory integration of balanceSurface Electromyography Biofeedback

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Sensory integration of Balance

    6 weeks

  • Low Back Pain

    6 weeks

  • Low back related functional disability

    6 weeks

  • Lumbar Range of Motion

    6 weeks

Study Arms (2)

Core stability protocol

ACTIVE COMPARATOR

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

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.

Procedure: Core stability exercisesDevice: Biofeedback training

Interventions

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 biofeedbackCore stability protocol

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

Core Stability with surface electromyography biofeedback

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foundation University Islamabad

Islamabad, Punjab Province, 46000, Pakistan

Location

Riphah University Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Rabiya Noor, Phd

    Riphah University Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Furqan Yaqoob, Phd*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

September 1, 2022

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations