Chronic Low-back PainNCT04968535
Effect of Regular Electrotherapy in Patients With Chronic Non-specific Neck Pain and Low-back Pain
A study testing StimaWELL in people with Chronic Low-back Pain and Chronic Pain, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This randomized controlled double-blinded pilot trial was performed in the Medical University of Vienna, Department of Special Anesthesia and Pain Medicine between 2015 and 2018. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain, Chronic Pain, Back Pain Without Radiation
- What is being tested?
- StimaWELL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jan 2015to 16 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic neck pain and/or low back pain longer than 3 month
- Minimum numeric pain rating scale equal or > 5
Who cannot join
- Change in pain medication within 4 weeks prior or during the enrollment (except intake of rescue medication)
- Additional pain therapies within 4 weeks prior or during the enrollment
- Epilepsy
- Pregnancy
- Previous experience in TENS
- Cardiac arrythmia/previous cardiac operation/implanted cardiac devices
Show all 9Show fewer
- Infection or malignancies affecting the spinal cord/previous spine operation
- Severe radicular pain with acute paralysis in the extremities
- Ongoing pension application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Regular Electrotherapy in Patients With Chronic Non-specific Neck Pain and Low-back Pain: a Randomized Controlled Double-blinded Pilot Trial
This randomized controlled double-blinded pilot trial was performed in the Medical University of Vienna, Department of Special Anesthesia and Pain Medicine between 2015 and 2018. Aim of the study was to assess the effect of regular electrotherapy applied on the spinal cord of patients with chronic non-specific neck pain and/or low-back pain. The hypothesis was that subjective feeling of pain, range of motion of the cervical and lumbar region, as well as the activity in daily living improved after weekly electrotherapy sessions for 30 min each.
Read the detailed description
Chronic neck pain and low-back pain are common causes for the decrease in quality of life. Unfortunately, efficacy of medical therapy is limited (Maher et al, 2017), and evidence for the efficacy of transcutaneous electrical nerve stimulation (TENS) therapy for both chronic neck pain (Martimbianco et al, 2019), as well as for chronic low-back pain (Khadilkar et al, 2008) is scarce .
With the aim to assess the effectiveness of regular electrotherapy in chronic pain patients applied via a mat covering the whole spinal cord, and thus allowing deeper current penetration into the tissue compared to conventional TENS, male and female patients with chronic neck pain or low back pain aged 18 years or over were enrolled in this study.
After informed consent, patients were randomly divided in three groups: Group 1 (verum) received right after device calibration suprathreshold electrotherapy on the whole back for 30 min weekly, Group 2 (Control) received device calibration without consequent electrotherapy, Group 3 (Control of Control) just lay on the mat without receiving device calibration nor electrotherapy.
Electrotherapy was applied using a mat covering the whole spinal cord called "StimaWELL". Therefore, all the patients were asked to put off the clothes and lay supine on the mat for 30 min in each session.
Primary outcome was the subjective pain sensation measured with the numeric pain rating scale (NRS). Secondary outcomes were cervical and lumbar range of motion and activities in daily living.
Data recorded before and after the sessions (i.e. NRS at rest, NRS under activity, average NRS in the last four weeks, maximum and minimum NRS, and Short-form Mc Gill Pain Questionnaire for pain sensation, measurement of the lumbar range of motion using Modified Schober and measurement of cervical range of motion using the Cervical range of Motion Device (CROM), assessment of activities in daily living using the Neck Disability Index and Rolland Morris Questionnaire) was compared in each group,respectively.
Inclusion criteria were a numeric pain rating scale (NRS) equal or more than 5 prior to study enrollment, and chronic pain in the cervical or lumbar Region longer than three month.
Exclusion criteria were pregnancy, prior experience in TENS, epilepsy, cardiac arrythmia, cardiac operation prior to study enrollment including implanted pacemaker or defibrillator, operation in the spinal cord, malignancies or infectious diseases affecting the spinal cord, severe radicular pain with acute paralysis in the extremities or an ongoing pension application.
Oral pain medication had to be unchanged at least four weeks before the study enrollment. Additional pain therapies like acupuncture, physical therapy, intravenous pain therapy or intramuscular or subcutaneous injection of pain medication were not accepted.
All patients, as well as the recruiting investigator and the physician performing the physical measurements and questionnaires were blinded.
- Being tested
- StimaWELL
- Keywords
- electrotherapy, chronic back pain, range of motion
- Medical subject headings
- Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimaWELLDevice
mid frequent electrotherapy mat covering the whole spinal cord with different stimulation protocols installed
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Experimental | Patients receiving suprathreshold electrotherapy in weekly intervals for a Duration of 30 min each. Device calibration with determination of the individual threshold was performed prior to the application of electrical current. Receives: Device: StimaWELL |
| Control | Sham comparator | Patients receiving device calibration without consequent electrotherapy. Receives: Device: StimaWELL |
| Control of control | No intervention | Patients lay on the mat without receiving device calibration nor electrotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in numeric pain rating scale at 8 weeks compared to baseline
Change from baseline subjective pain sensation from 0 (no pain) to 10 (maximum pain) at 8 weeks
Measured: 8 weeks
Secondary outcomes (4)
change in cervical range of motion at 8 weeks compared to baseline
Cervical range of motion measured in degree using CROM (cervical range of motion device; the higher the number, the better the mobility).
Measured: 8 weeks
change in lumbar range of motion at 8 weeks compared to baseline
Lumbar range of motion measured in cm using the Modified Schober Method (measurement of the skin distance 10 cm above and 5 cm below the posterior superior iliac spine during anteflexion and retroflexion, respectively. The higher the value in anteflexion, the better the mobility; the smaller the measured skin distance in retroflexion, the better the mobility).
Measured: 8 weeks
Change in activity in daily living influenced by neck pain at 8 weeks compared to baseline
Change in the activity in daily living after 8 weeks compared to baseline using a questionnaire called "Neck Disability Index" for cervicalgia: Minimum 0 points (no disability), maximum 50 Points (severe disability); score calculation: Points examined divided 50 times 100; the higher, the more disabled in daily living due to chronic neck pain.
Measured: 8 weeks
Change in activity in daily living influenced by low back pain at 8 weeks compared to baseline
Change in the activity in daily living after 8 weeks compared to baseline using "Rolland Morris Disability Questionnaire" for low back pain: Minimum 0 points (no disability), Maximum 24 points. The higher the score, the more disabled due to low back pain.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start8 Jan 2015
- Primary completion16 Oct 2018
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 controlled double blinded pilot study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Asami Naka, Medical University of Vienna
- Investigators
- Sabine Sator-Katzenschlager, Prof., MD, Principal investigator, Department of Special Anesthesia and Pain Medicine, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968535
- Sponsor's protocol ID
- INS-621000-0687-002
- Status last verified
- Jul 2021
- First submitted
- 13 Apr 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
PubMed 27745712Martimbianco ALC, Porfirio GJ, Pacheco RL, Torloni MR, Riera R. Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain. Cochrane Database Syst Rev. 2019 Dec 12;12(12):CD011927. doi: 10.1002/14651858.CD011927.pub2.
PubMed 31830313Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003008. doi: 10.1002/14651858.CD003008.pub3.
PubMed 18843638
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Regular Electrotherapy in Patients With Chronic Non-specific Neck Pain and Low-back Pain: a Randomized Controlled Double-blinded Pilot Trial
- ClinicalTrials.gov ID
- NCT04968535
- Acronym / sponsor ID
- INS-621000-0687-002
- Keywords
- electrotherapy, chronic back pain, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 8 Jan 2015 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 20 Jul 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 randomized controlled double-blinded pilot trial was performed in the Medical University of Vienna, Department of Special Anesthesia and Pain Medicine between 2015 and 2018. Aim of the study was to assess the effect of regular electrotherapy applied on the spinal cord of patients with chronic non-specific neck pain and/or low-back pain. The hypothesis was that subjective feeling of pain, range of motion of the cervical and lumbar region, as well as the activity in daily living improved after weekly electrotherapy sessions for 30 min each.
Detailed description
Chronic neck pain and low-back pain are common causes for the decrease in quality of life. Unfortunately, efficacy of medical therapy is limited (Maher et al, 2017), and evidence for the efficacy of transcutaneous electrical nerve stimulation (TENS) therapy for both chronic neck pain (Martimbianco et al, 2019), as well as for chronic low-back pain (Khadilkar et al, 2008) is scarce .
With the aim to assess the effectiveness of regular electrotherapy in chronic pain patients applied via a mat covering the whole spinal cord, and thus allowing deeper current penetration into the tissue compared to conventional TENS, male and female patients with chronic neck pain or low back pain aged 18 years or over were enrolled in this study.
After informed consent, patients were randomly divided in three groups: Group 1 (verum) received right after device calibration suprathreshold electrotherapy on the whole back for 30 min weekly, Group 2 (Control) received device calibration without consequent electrotherapy, Group 3 (Control of Control) just lay on the mat without receiving device calibration nor electrotherapy.
Electrotherapy was applied using a mat covering the whole spinal cord called "StimaWELL". Therefore, all the patients were asked to put off the clothes and lay supine on the mat for 30 min in each session.
Primary outcome was the subjective pain sensation measured with the numeric pain rating scale (NRS). Secondary outcomes were cervical and lumbar range of motion and activities in daily living.
Data recorded before and after the sessions (i.e. NRS at rest, NRS under activity, average NRS in the last four weeks, maximum and minimum NRS, and Short-form Mc Gill Pain Questionnaire for pain sensation, measurement of the lumbar range of motion using Modified Schober and measurement of cervical range of motion using the Cervical range of Motion Device (CROM), assessment of activities in daily living using the Neck Disability Index and Rolland Morris Questionnaire) was compared in each group,respectively.
Inclusion criteria were a numeric pain rating scale (NRS) equal or more than 5 prior to study enrollment, and chronic pain in the cervical or lumbar Region longer than three month.
Exclusion criteria were pregnancy, prior experience in TENS, epilepsy, cardiac arrythmia, cardiac operation prior to study enrollment including implanted pacemaker or defibrillator, operation in the spinal cord, malignancies or infectious diseases affecting the spinal cord, severe radicular pain with acute paralysis in the extremities or an ongoing pension application.
Oral pain medication had to be unchanged at least four weeks before the study enrollment. Additional pain therapies like acupuncture, physical therapy, intravenous pain therapy or intramuscular or subcutaneous injection of pain medication were not accepted.
All patients, as well as the recruiting investigator and the physician performing the physical measurements and questionnaires were blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- randomized controlled double blinded pilot study
| Arm | Type | Receives |
|---|---|---|
| Therapy | Experimental | Device: StimaWELLPatients receiving suprathreshold electrotherapy in weekly intervals for a Duration of 30 min each. Device calibration with determination of the individual threshold was performed prior to the application of electrical current. |
| Control | Sham comparator | Device: StimaWELLPatients receiving device calibration without consequent electrotherapy. |
| Control of control | No intervention | –Patients lay on the mat without receiving device calibration nor electrotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic neck pain and/or low back pain longer than 3 month
- Minimum numeric pain rating scale equal or > 5
Key exclusion criteria (9 listed)
- Change in pain medication within 4 weeks prior or during the enrollment (except intake of rescue medication)
- Additional pain therapies within 4 weeks prior or during the enrollment
- Epilepsy
- Pregnancy
- Previous experience in TENS
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 |
|---|---|---|
| StimaWELLmid frequent electrotherapy mat covering the whole spinal cord with different stimulation protocols installed | Device | Control, Therapy |
Primary outcome
change in numeric pain rating scale at 8 weeks compared to baseline
Time frame: 8 weeks
Change from baseline subjective pain sensation from 0 (no pain) to 10 (maximum pain) at 8 weeks
4 secondary outcomes
change in cervical range of motion at 8 weeks compared to baseline
Time frame: 8 weeks
change in lumbar range of motion at 8 weeks compared to baseline
Time frame: 8 weeks
Change in activity in daily living influenced by neck pain at 8 weeks compared to baseline
Time frame: 8 weeks
Change in activity in daily living influenced by low back pain at 8 weeks compared to baseline
Time frame: 8 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 20 Jul 2021.
- Background: PubMed 27745712Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
- Background: PubMed 31830313Martimbianco ALC, Porfirio GJ, Pacheco RL, Torloni MR, Riera R. Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain. Cochrane Database Syst Rev. 2019 Dec 12;12(12):CD011927. doi: 10.1002/14651858.CD011927.pub2.
- Background: PubMed 18843638Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003008. doi: 10.1002/14651858.CD003008.pub3.
- 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.
Sabine Sator-Katzenschlager, Prof., MD principal investigator
Department of Special Anesthesia and Pain Medicine, Medical University of Vienna
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 in people with Chronic Low-back Pain and Chronic Pain, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 9 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 20 Jul 2021. 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 Austria. 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. Some participants in this study may receive a placebo. 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 numeric pain rating scale at 8 weeks compared to baseline (time frame: 8 weeks). 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 NCT04968535, which also lists 3 linked publications.
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 20 Jul 2021.