Low Back PainNCT04891692
Effect of Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain
A study testing StimaWell 120MTRS system in people with Low Back Pain and Paraspinal Muscles, run by Concordia University, Montreal at 1 site in Canada.
Trial summary
This study evaluates the effect of a 10-week long intervention with the StimaWELL 120MTRS system on multifidus morphology and function in individuals with chronic low back pain. Half the participants will receive muscle therapy at the device's phasic setting, while half will receive muscle therapy at the device's… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Paraspinal Muscles
- What is being tested?
- StimaWell 120MTRS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 22 Feb 2021to 23 Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic non-specific LBP (>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain.
- Aged between 18 to 60 years old.
- English or French speakers
- At least a 4/10 score on an 11-point Numerical Pain Rating Scale (NPRS) for pain intensity.
- The score will be the average of current pain, and best and worst pain over the previous week.
- At least a 'moderate' Modified Oswestry Disability Index (ODI) score.
- Able to undergo MRI exam.
Who cannot join
- Currently undergoing or having received physical therapy treatment in the previous month
- Consistent motor control training for the low back and / or consistent weightlifting, power-lifting, bodybuilding, or strongman training in the previous 6 weeks
- History of lumbar surgery
- Presence of positive lumbosacral dermatomes or myotomes
- Presence of disease which could affect the stiffness of muscle tissue (collagen tissue disease, hemiplegia, multiple sclerosis, blood clots)
- Presence of systemic disease (cancer, metabolic syndrome)
Show all 18Show fewer
- Presence of rheumatoid arthritis
- Presence of spinal stenosis, fracture, infection, or tumor
- Presence of lumbar scoliosis greater than 10 degrees
- Presence of cardiac arrhythmia
- Pregnant and breastfeeding women
- Individuals with epilepsy
- Individuals at risk for serious bleeding
- Individuals with pacemakers or metal implants
- Individuals with aneurysms or heart valve clips
- Individuals with tattoos or piercings in the lumbar spine
- Individuals who have taken prescribed muscle relaxants more than once a week over the past month
- BMI > 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neuromuscular Electrical Stimulation Using the StimaWELL 120MTRS System on Multifidus Muscle Morphology and Function in Patients With Chronic Low Back Pain
This study evaluates the effect of a 10-week long intervention with the StimaWELL 120MTRS system on multifidus morphology and function in individuals with chronic low back pain. Half the participants will receive muscle therapy at the device's phasic setting, while half will receive muscle therapy at the device's combined setting. This study also evaluates the acute effect of a single treatment with the StimaWELL 120MTRS on multifidus stiffness in individuals with chronic low back pain.
- Conditions
- Low Back Pain, Paraspinal Muscles
- Being tested
- StimaWell 120MTRS system
- Keywords
- Diagnostic Imaging, Electrical Stimulation Therapy, Low Back Pain, Paraspinal Muscles
- 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.
StimaWell 120MTRS systemDevice
Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.
| Study group | Role | What they receive |
|---|---|---|
| Phasic Treatment Group | Experimental | Muscle therapy for the lumbar spine at the StimaWell 120MTRS system's phasic setting. Treatment at 3 kHz, modulation 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment. Receives: Device: StimaWell 120MTRS system |
| Combined Treatment Group | Experimental | Muscle therapy for the lumbar spine at the StimaWell 120MTRS system's combined (tonic and phasic) setting. Treatment at 3 kHz, modulation 4 Hz and 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment. Receives: Device: StimaWell 120MTRS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in multifidus muscle size (cross-sectional area)
Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-SI spinal levels.
Measured: Baseline, after 10 weeks
Change in multifidus muscle fat infiltration
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-S1 spinal levels
Measured: Baseline, after 10 weeks
Change in multifidus muscle function (% thickness change)
Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via prone contralateral arm lifts will be assessed by ultrasound.
Measured: Baseline, after 10 weeks
Change in multifidus muscle stiffness
Multifidus muscle stiffness, obtained at rest in a prone position, with prone contralateral arm lifts, and in a standing position, will be assessed by ultrasound (shear-wave elastography)
Measured: Baseline, after 10 weeks
Change in multifidus muscle stiffness
Multifidus muscle stiffness, obtained at rest in a prone position, and in a standing position, will be assessed by ultrasound (shear-wave elastography)
Measured: Before and 15 minutes after 3rd treatment
Secondary outcomes (7)
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity at present
The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable
Measured: Baseline, before and after each treatment, after 10 weeks
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (best and worst pain over previous week)
The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable
Measured: Baseline, prior to 11th treatment, after 10 weeks
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (sitting and with movement over past 24h)
The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable
Measured: Baseline, prior to 11th treatment, after 10 weeks
Change in the Numerical Pain Rating Scale (NPRS) for overall leg pain intensity in the past week
The NPRS measures pain intensity on a scale of 0 - 10, with 0 being no pain, and 10 being the worst pain imaginable
Measured: Baseline, prior to 11th treatment, after 10 weeks
Change in the Oswestry Disability Index (ODI)
The ODI is used to measure the participant's level of disability in relation to LBP. It is a 10-item scale in which each item is rated from 0-6. Higher scores indicate greater disability.
Measured: Baseline, prior to 11th treatment, after 10 weeks
Change in the Pain Catastrophizing Scale (PCS)
The PCS is a 13-item questionnaire that assesses the participant's level of catastrophizing. Each item is rated from 0-4 for a possible total of 52. Higher scores indicate greater catastrophizing.
Measured: Baseline, prior to 11th treatment, after 10 weeks
Change in the Brief Pain Inventory - Interference (BPI)
The BPI-I is a 7-item questionnaire that measures how pain interferes with activities of daily living. Each item is rated from 0-10. Higher scores indicative greater interference.
Measured: Baseline, prior to 11th treatment, after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start22 Feb 2021
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891692
- Sponsor's protocol ID
- CCER 20-21-07
- Status last verified
- Aug 2023
- First submitted
- 13 May 2021
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fortin M, Wolfe D, Dover G, Boily M. The effect of phasic versus combined neuromuscular electrical stimulation using the StimaWELL 120MTRS system on multifidus muscle morphology and function in patients with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2022 Jul 1;23(1):627. doi: 10.1186/s12891-022-05578-1.
PubMed 35773711
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Electrical Stimulation Using the StimaWELL 120MTRS System on Multifidus Muscle Morphology and Function in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04891692
- Acronym / sponsor ID
- CCER 20-21-07
- Conditions
- Low Back Pain, Paraspinal Muscles
- Keywords
- Diagnostic Imaging, Electrical Stimulation Therapy, Low Back Pain, Paraspinal Muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 18 May 2021 (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 evaluates the effect of a 10-week long intervention with the StimaWELL 120MTRS system on multifidus morphology and function in individuals with chronic low back pain. Half the participants will receive muscle therapy at the device's phasic setting, while half will receive muscle therapy at the device's combined setting. This study also evaluates the acute effect of a single treatment with the StimaWELL 120MTRS on multifidus stiffness in individuals with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phasic Treatment Group | Experimental | Device: StimaWell 120MTRS systemMuscle therapy for the lumbar spine at the StimaWell 120MTRS system's phasic setting. Treatment at 3 kHz, modulation 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment. |
| Combined Treatment Group | Experimental | Device: StimaWell 120MTRS systemMuscle therapy for the lumbar spine at the StimaWell 120MTRS system's combined (tonic and phasic) setting. Treatment at 3 kHz, modulation 4 Hz and 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Chronic non-specific LBP (>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain.
- Aged between 18 to 60 years old.
- English or French speakers
- At least a 4/10 score on an 11-point Numerical Pain Rating Scale (NPRS) for pain intensity.
- The score will be the average of current pain, and best and worst pain over the previous week.
Key exclusion criteria (18 listed)
- Currently undergoing or having received physical therapy treatment in the previous month
- Consistent motor control training for the low back and / or consistent weightlifting, power-lifting, bodybuilding, or strongman training in the previous 6 weeks
- History of lumbar surgery
- Presence of positive lumbosacral dermatomes or myotomes
- Presence of disease which could affect the stiffness of muscle tissue (collagen tissue disease, hemiplegia, multiple sclerosis, blood clots)
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 |
|---|---|---|
| StimaWell 120MTRS systemMedium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C. | Device | Combined Treatment Group, Phasic Treatment Group |
Primary outcome
Change in multifidus muscle size (cross-sectional area)
Time frame: Baseline, after 10 weeks
Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-SI spinal levels.
Change in multifidus muscle fat infiltration
Time frame: Baseline, after 10 weeks
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) at L4-L5 and L5-S1 spinal levels
Change in multifidus muscle function (% thickness change)
Time frame: Baseline, after 10 weeks
Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via prone contralateral arm lifts will be assessed by ultrasound.
Change in multifidus muscle stiffness
Time frame: Baseline, after 10 weeks
Multifidus muscle stiffness, obtained at rest in a prone position, with prone contralateral arm lifts, and in a standing position, will be assessed by ultrasound (shear-wave elastography)
Change in multifidus muscle stiffness
Time frame: Before and 15 minutes after 3rd treatment
Multifidus muscle stiffness, obtained at rest in a prone position, and in a standing position, will be assessed by ultrasound (shear-wave elastography)
7 secondary outcomes
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity at present
Time frame: Baseline, before and after each treatment, after 10 weeks
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (best and worst pain over previous week)
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Change in the Numerical Pain Rating Scale (NPRS) for low back pain intensity (sitting and with movement over past 24h)
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Change in the Numerical Pain Rating Scale (NPRS) for overall leg pain intensity in the past week
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Change in the Oswestry Disability Index (ODI)
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Change in the Pain Catastrophizing Scale (PCS)
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Change in the Brief Pain Inventory - Interference (BPI)
Time frame: Baseline, prior to 11th treatment, after 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 35773711Fortin M, Wolfe D, Dover G, Boily M. The effect of phasic versus combined neuromuscular electrical stimulation using the StimaWELL 120MTRS system on multifidus muscle morphology and function in patients with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2022 Jul 1;23(1):627. doi: 10.1186/s12891-022-05578-1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StimaWell 120MTRS system in people with Low Back Pain and Paraspinal Muscles, run by Concordia University, Montreal at 1 site in Canada.
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 7 inclusion and 18 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 8 Mar 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in multifidus muscle size (cross-sectional area) (time frame: Baseline, after 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891692, which also lists 1 linked publication.
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 8 Mar 2024.