NCT06387563

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

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

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

November 6, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 23, 2024

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Group A: Abdominal activation using pressure biofeedback

EXPERIMENTAL

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

Procedure: Abdominal activation using pressure biofeedback

Group B: Abdominal activation using SEMG biofeedback

EXPERIMENTAL

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

Procedure: Abdominal activation using SEMG biofeedback

Interventions

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 A: Abdominal activation using pressure 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: 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

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Iqra Ali, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 29, 2024

Study Start

November 6, 2023

Primary Completion

May 1, 2024

Study Completion

May 30, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations