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

Not Applicable

Recruiting

• Conditions: Low Back Pain
• Interventions: Procedure: Abdominal activation using pressure biofeedback; Procedure: Abdominal activation using SEMG biofeedback

• Registration Number: NCT06387563
• Lead Sponsor: Foundation University Islamabad

Brief Summary

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.

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 Timeline

• Study Start: 2023-11-06
• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Abdominal activation using pressure biofeedback	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: 1. Supine abdominal muscle activation (45° Hip knee flexion) 2. Both hip and knee 90° flexion 3. One side hip and knee 90° flexion with other fully extended 4. One side hip and knee 90° flexion with other fully extended + heel 12 cm raised 5. Both legs fully extended with heel 12 cm raised 6. Partial curl ups 7. Prone lying abdominal muscle activation 8. Prone leg raises 9. Prone upper back extension simple 10. Prone reciprocal UE/LE exercises
Group B: Abdominal activation using SEMG biofeedback	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: 1. Supine abdominal muscle activation (45° Hip knee flexion) 2. Both hip and knee 90° flexion 3. One side hip and knee 90° flexion with other fully extended 4. One side hip and knee 90° flexion with other fully extended + heel 12 cm raised 5. Both legs fully extended with heel 12 cm raised 6. Partial curl ups 7. Prone lying abdominal muscle activation 8. Prone leg raises 9. Prone upper back extension simple 10. Prone reciprocal UE/LE exercises

Primary Outcome Measures

Name	Time	Method
Pain Intensity	4 weeks	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.
Level of Disability	4 weeks	For measuring disability, Oswestry Disability Index will be utilized

Trial Locations

Locations (1)

Foundation University College of Physical Therapy; 🇵🇰 Rawalpindi, Punjab, Pakistan