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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06387563
• Other study ID #: FUI/CTR/2024/4
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2024
• Source: Foundation University Islamabad
• Contact: Iqra Ali, MS-MSKPT*
• Phone: 0316-5187052
• Email: iqraalianmol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Back Pain

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	Foundation University College of Physical Therapy	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Level of Disability	For measuring disability, Oswestry Disability Index will be utilized	4 weeks