Low Back PainNCT02864732
Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain
A study testing Rehabilitation exercises and Electrical Stimulation in people with Low Back Pain, run by University of Pittsburgh.
Trial summary
The purpose of this study is to investigate the feasibility of applying neuromuscular electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and whether the electrical stimulation improve pain, function and muscle strength. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Rehabilitation exercises and Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 years of age and 60.
- Body Mass Index (BMI) of less than 34.
- Low Back Pain duration of 3 months or greater (chronic).
- Minimum pain level on Numeric Pain Rating Scale (NPRS) is 3 or greater.
- Minimum score of Modified Oswestry Disability Questionnaire (MODQ) is 20 or greater.
- Understands English
Who cannot join
- Positive nerve root tension signs
- Progressive neurological deficit
- Positive Babinski sign.
- Sensory loss that is not in correspondence with dermatomal distribution or peripheral nerves.
- History of spinal surgery
- History of inflammatory joint disease
Show all 10Show fewer
- Contraindications to physical exercise including history of cardiac disease or being told by a physician not to engage in physical exercise.
- Contraindications to NMES including cardiac pacemaker or skin allergy to adhesives
- History of metastatic cancer in previous 5 years or present treatment for cancer
- Women who indicate that they are pregnant or plan to become pregnant
About this study
Official title: A Comparison Between Stabilization Exercises and Stabilization Exercises Supplemented With Neuromuscular Electrical Stimulation: A Feasibility Study
The purpose of this study is to investigate the feasibility of applying neuromuscular electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and whether the electrical stimulation improve pain, function and muscle strength.
- Conditions
- Low Back Pain
- Being tested
- Rehabilitation exercises, Electrical Stimulation
- Keywords
- Low back pain, stabilization exercises, neuromuscular electrical stimulation
- 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.
Rehabilitation exercisesOther
Electrical StimulationDevice
Also called Neuromuscular Electrical Stimulation (NMES)
| Study group | Role | What they receive |
|---|---|---|
| Stabilization exercises | Experimental | The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance. Receives: Other: Rehabilitation exercises |
| Stabilization exercises plus electrical stimulation | Experimental | The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program. Receives: Other: Rehabilitation exercises; Device: Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of Electrical Stimulation (NMES)
NMES tolerability was performed by asking each subject in the stab + NMES group to describe their subjective perception of both the intensity and discomfort of the NMES current using the descriptors listed in a table. The descriptors represent two distinct domains of adjectives: the sensory aspect of the perceived intensity of stimulation and the affective aspect of the perceived discomfort. Each aspect has 15 adjectives. Each subject was asked to describe the current using the descriptors listed for each aspect at baseline and at 6 weeks.
To analyze the the subjects description of the current, the 15 descriptors of each aspect were divided into 3 zones (high, medium, low). The top 5 descriptors in each aspect were considered high, the middle 5 descriptors were considered medium, and the bottom descriptors were considered low.
Descriptive statistics were used to compare the subjects description of each aspect at baseline and at 6 weeks follow-up.
Measured: Participants were followed from baseline to 6 weeks
Modified Oswestry Disability Questionnaire (MODQ)
The MODQ is a self-reported measure of disability consisting of 10 domains of functional activities related to low back pain. The domains include pain intensity, personal care, lifting, walking, standing, sitting, traveling, social life, employment/homemaking, and sleeping. Each domain is rated from 0 - 5. The total of all the domains range from 0 - 50. The scores can be multiplied by 2 to get a percentage of functional disability. The higher the percentage the higher the disability.
Measured: Baseline to 6 weeks (post-treatment) to 10 weeks (follow up).
Secondary outcomes (4)
Numeric Pain Rating Scale (NPRS)
The NPRS measures pain intensity on an 11-point scale from 0 (no pain) to 10 (maximum pain). The higher the score the worst the pain intensity
Measured: Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up)
Fear-avoidance Behavior Questionnaire
The Fear-avoidance Behavior Questionnaire (FABQ) measure avoidant behavior to physical activity or work due to fear of pain. The has two sub scales: physical activity and work. This FABQ consists of 16 items; 5 items for the physical activity sub scale and 11 items for the work subscale. Each item is scored from 0-6. Higher scores on the FABQ are indicative of greater fear and avoidance beliefs. The total score on the FABQ is 66, however, this score is considered separately. The FABQ-physical activity sub scale ranges from 0 - 24 points and the FABQ-work activity ranges from 0 - 42 points.
Measured: Baseline to 6 weeks (post-treatment)
Paraspinal Muscle Strength
The paraspinal muscle strength was assessed using the Biodex 3 Pro dynamometer (20 Ramsey Rd, Shirley, NY 11967). Active extension of the trunk was performed with the subject in a semi-standing position; the subject's hips were flexed at 60 degrees with the feet resting on an adjustable footrest. The thighs were secured to the seat with two Velcro straps. The scapulae rested against a roll that is attached to the chair arms. The trunk was secured with two Velcro straps that crossed the front trunk forming the shape of an X. The subject was asked to extend the trunk by exerting maximal isometric contraction for 5 seconds against the scapular roll. The average of three 5-second trials was recorded. All subjects received the same verbal instruction: "Push your trunk against the scapular roll as strong as you can". The higher the score the stronger the muscles. The range starts from 0 without a limit to the amount of force that could be exerted.
Measured: Baseline - 6 weeks (post-treatment)
Patient Satisfaction Survey
Satisfaction level with the interventions. Subjects were asked rate their satisfaction with the treatment by choosing one of the following statements:
Very satisfied Satisfied Neutral Unsatisfied Very unsatisfied
Measured: only post-treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Saudi Arabian Cultural Mission, King Fahad Specialist Hospital Dammam
- Responsible party
- Sponsor
- Investigators
- Muhammad Z Alrwaily, PhD, Principal investigator, University of PittsburghAnthony Delitto, PhD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864732
- Sponsor's protocol ID
- PRO12100651
- Status last verified
- Oct 2017
- First submitted
- 4 Aug 2016
- Last updated
- 22 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Stabilization Exercises and Stabilization Exercises Supplemented With Neuromuscular Electrical Stimulation: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02864732
- Acronym / sponsor ID
- PRO12100651
- Conditions
- Low Back Pain
- Keywords
- Low back pain, stabilization exercises, neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Saudi Arabian Cultural Mission, King Fahad Specialist Hospital Dammam
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the feasibility of applying neuromuscular electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and whether the electrical stimulation improve pain, function and muscle strength.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization exercises | Experimental | Other: Rehabilitation exercisesThe stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance. |
| Stabilization exercises plus electrical stimulation | Experimental | Other: Rehabilitation exercises, Device: Electrical StimulationThe neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 18 years of age and 60.
- Body Mass Index (BMI) of less than 34.
- Low Back Pain duration of 3 months or greater (chronic).
- Minimum pain level on Numeric Pain Rating Scale (NPRS) is 3 or greater.
- Minimum score of Modified Oswestry Disability Questionnaire (MODQ) is 20 or greater.
Key exclusion criteria (10 listed)
- Positive nerve root tension signs
- Progressive neurological deficit
- Positive Babinski sign.
- Sensory loss that is not in correspondence with dermatomal distribution or peripheral nerves.
- History of spinal surgery
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 |
|---|---|---|
| Rehabilitation exercises | Other | Stabilization exercises, Stabilization exercises plus electrical stimulation |
| Electrical StimulationAlso: Neuromuscular Electrical Stimulation (NMES) | Device | Stabilization exercises plus electrical stimulation |
Primary outcome
Tolerability of Electrical Stimulation (NMES)
Time frame: Participants were followed from baseline to 6 weeks
NMES tolerability was performed by asking each subject in the stab + NMES group to describe their subjective perception of both the intensity and discomfort of the NMES current using the descriptors listed in a table. The descriptors represent two distinct domains of adjectives: the sensory aspect of the perceived intensity of stimulation and the affective aspect of the perceived discomfort. Each aspect has 15 adjectives. Each subject was asked to describe the current using the descriptors listed for each aspect at baseline and at 6 weeks. To analyze the the subjects description of the current, the 15 descriptors of each aspect were divided into 3 zones (high, medium, low). The top 5 descriptors in each aspect were considered high, the middle 5 descriptors were considered medium, and the bottom descriptors were considered low. Descriptive statistics were used to compare the subjects description of each aspect at baseline and at 6 weeks follow-up.
Modified Oswestry Disability Questionnaire (MODQ)
Time frame: Baseline to 6 weeks (post-treatment) to 10 weeks (follow up).
The MODQ is a self-reported measure of disability consisting of 10 domains of functional activities related to low back pain. The domains include pain intensity, personal care, lifting, walking, standing, sitting, traveling, social life, employment/homemaking, and sleeping. Each domain is rated from 0 - 5. The total of all the domains range from 0 - 50. The scores can be multiplied by 2 to get a percentage of functional disability. The higher the percentage the higher the disability.
4 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up)
Fear-avoidance Behavior Questionnaire
Time frame: Baseline to 6 weeks (post-treatment)
Paraspinal Muscle Strength
Time frame: Baseline - 6 weeks (post-treatment)
Patient Satisfaction Survey
Time frame: only post-treatment at 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
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.
Muhammad Z Alrwaily, PhD principal investigator
University of Pittsburgh
Anthony Delitto, PhD study director
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation exercises and Electrical Stimulation in people with Low Back Pain, run by University of Pittsburgh.
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 10 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: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Electrical Stimulation (NMES) (time frame: Participants were followed from baseline to 6 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 22 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.