Low Back PainNCT06387563
Effects of Abdominal Muscle Activation Training, Using Pressure Biofeedback in Comparison With Surface Electromyography
A study testing Abdominal activation using pressure biofeedback and Abdominal activation using SEMG biofeedback in people with Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Abdominal activation using pressure biofeedback and Abdominal activation using SEMG biofeedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Nov 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Anam Rehman, MS-OMPT, 03355082299, anam.rehman@fui.edu.pk
About this study
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.
Read the 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:
- Numeric pain rating scale (NPRS)
- 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.
- Conditions
- Low Back Pain
- Being tested
- Abdominal activation using pressure biofeedback, Abdominal activation using SEMG biofeedback
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal activation using pressure biofeedbackProcedure or surgery
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 biofeedbackProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Abdominal activation using SEMG biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Level of Disability
For measuring disability, Oswestry Disability Index will be utilized
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start6 Nov 2023
- Primary completion1 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387563
- Sponsor's protocol ID
- FUI/CTR/2024/4
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Muscle Activation Training, Using Pressure Biofeedback in Comparison With Surface Electromyography
- ClinicalTrials.gov ID
- NCT06387563
- Acronym / sponsor ID
- FUI/CTR/2024/4
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Numeric pain rating scale (NPRS)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Group A: Abdominal activation using pressure biofeedback | Experimental | Procedure: Abdominal activation using pressure biofeedbackGroup 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 | Experimental | Procedure: Abdominal activation using SEMG biofeedbackGROUP 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 |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal activation using pressure biofeedbackPBF 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 or surgery | Group A: Abdominal activation using pressure biofeedback |
| Abdominal activation using SEMG biofeedbackSEMG-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 or surgery | Group B: Abdominal activation using SEMG biofeedback |
Primary outcome
Pain Intensity
Time frame: 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
Time frame: 4 weeks
For measuring disability, Oswestry Disability Index will be utilized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal activation using pressure biofeedback and Abdominal activation using SEMG biofeedback in people with Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iqra Ali, MS-MSKPT* (0316-5187052, iqraalianmol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.