Effects of Abdominal Muscle Activation Training, Using Pressure Biofeedback in Comparison With Surface Electromyography

This study is a randomized control trial and the purpose of this study to determine the effects of abdominal muscle activation training on non-specific low back pain; using pressure biofeedback in comparison with surface electromyography biofeedback: a randomized control trial.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Abdominal activation using pressure biofeedback; Procedure: Abdominal activation using SEMG biofeedback

Detailed Description

The purpose of this study is to determine the effects of abdominal muscle activation training, using pressure biofeedback in comparison with surface electromyography biofeedback, in management of non-specific low back pain: a randomized control trial.

Pain and disability are the primary outcomes which will be determined using:

1. Numeric pain rating scale (NPRS)
2. Oswestry disability index (ODI) Data will be taken before and after the intervention protocol for each participant.

Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iqra Ali, MS-MSKPT*; Phone Number: 0316-5187052; Email: iqraalianmol@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Foundation University College of Physical Therapy
      • Contact: Anam Rehman, MS-OMPT; Phone Number: 03355082299; Email: anam.rehman@fui.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age (adults 19 - 44 years)
• Non-specific LBP with NPRS > 3
• Negative SLR test in prone and supine
• Painless extremity movement and activity
• Manual muscle testing of abdominal muscles between grade 2 - 4
• Sedentary individuals (no exercise plan followed in last 3 months)

Exclusion Criteria:

• History of any spinal surgery
• Degenerative disc disorder, facet joint syndrome, spinal stenosis, myelopathy, lumbar syringomyelia
• Sensory disturbances due to neurological causes, lumbar radiculopathy, fibromyalgia, myofascial pain syndrome
• Sacroiliac joint dysfunction
• Pregnancy
• Medical conditions; Hypertension, Diabetes mellites
• Work disability greater than 6 months
• Not able to attend regular therapy appointments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Abdominal activation using pressure biofeedback; Group A PBF assisted abdominal muscle activation training (30 min, 3x /week /4 weeks) Progressive Muscle Relaxation for 5 min Pressure biofeedback assisted abdominal muscle activation training. Frequency: 25 min; 10 sec hold, 15 sec relax, 10 reps Progression criteria in training: Maintaining 3 - 5 mmHg pressure on PBF dial while performing abdominal muscle activation. Exercises for Group For biofeedback assisted abdominal muscle activation training these exercises will be performed: Supine abdominal muscle activation (45° Hip knee flexion); Both hip and knee 90° flexion; One side hip and knee 90° flexion with other fully extended; One side hip and knee 90° flexion with other fully extended + heel 12 cm raised; Both legs fully extended with heel 12 cm raised; Partial curl ups; Prone lying abdominal muscle activation; Prone leg raises; Prone upper back extension simple; Prone reciprocal UE/LE exercises	Procedure: Abdominal activation using pressure biofeedback; PBF assisted abdominal muscle activation training (30 min, 3x /week /4 weeks) Progressive Muscle Relaxation for 5 min Pressure biofeedback assisted abdominal muscle activation training. Frequency: 25 min; 10 sec hold, 15 sec relax, 10 reps Progression criteria in training: Maintaining 3 - 5 mmHg pressure on PBF dial while performing abdominal muscle activation. Exercises for Group For biofeedback assisted abdominal muscle activation training these exercises will be performed: Supine abdominal muscle activation (45° Hip knee flexion); Both hip and knee 90° flexion; One side hip and knee 90° flexion with other fully extended; One side hip and knee 90° flexion with other fully extended + heel 12 cm raised; Both legs fully extended with heel 12 cm raised; Partial curl ups; Prone lying abdominal muscle activation; Prone leg raises; Prone upper back extension simple; Prone reciprocal UE/LE exercises
Experimental: Group B: Abdominal activation using SEMG biofeedback; GROUP B: SEMG-BF assisted abdominal muscle activation training (30 min, 3x/ week/ 4 weeks) Progressive Muscle Relaxation for 5 min Surface EMG-BF assisted abdominal muscle activation training. Frequency: 25 min; 10 sec hold, 15 sec relax, 10 reps Maintaining minimal volumetric contraction of abdominal muscle activation (as per person) on SEMG device with abdominal muscle activation for set frequency Exercises for Group B For biofeedback assisted abdominal muscle activation training these exercises will be performed: Supine abdominal muscle activation (45° Hip knee flexion); Both hip and knee 90° flexion; One side hip and knee 90° flexion with other fully extended; One side hip and knee 90° flexion with other fully extended + heel 12 cm raised; Both legs fully extended with heel 12 cm raised; Partial curl ups; Prone lying abdominal muscle activation; Prone leg raises; Prone upper back extension simple; Prone reciprocal UE/LE exercises	Procedure: Abdominal activation using SEMG biofeedback; SEMG-BF assisted abdominal muscle activation training (30 min, 3x/ week/ 4 weeks) Progressive Muscle Relaxation for 5 min Surface EMG-BF assisted abdominal muscle activation training. Frequency: 25 min; 10 sec hold, 15 sec relax, 10 reps Maintaining minimal volumetric contraction of abdominal muscle activation (as per person) on SEMG device with abdominal muscle activation for set frequency Exercises for Group B For biofeedback assisted abdominal muscle activation training these exercises will be performed: Supine abdominal muscle activation (45° Hip knee flexion); Both hip and knee 90° flexion; One side hip and knee 90° flexion with other fully extended; One side hip and knee 90° flexion with other fully extended + heel 12 cm raised; Both legs fully extended with heel 12 cm raised; Partial curl ups; Prone lying abdominal muscle activation; Prone leg raises; Prone upper back extension simple; Prone reciprocal UE/LE exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	The NPRS will be used to quantify LBP, and it exhibits good validity ranging from 0.79 to 0.95, as well as reliability ranging from 0.67 to 0.96(23). The scoring for NPRS involves a scale from 0 to 10, where 0 indicates no pain. The interpretation of scores is as follows: 0 to 3 for mild pain, 4 to 6 for moderate pain, and 7 to 10 for severe pain.	4 weeks
Level of Disability	For measuring disability, Oswestry Disability Index will be utilized	4 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: FUI/CTR/2024/4

Drug and device information, study documents

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