Chronic Low Back PainNCT06638229
Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain
A study testing The StimaWELL 120MTRS system in people with Chronic Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effectiveness of a specific electrotherapy treatment for individuals with chronic non-specific low back pain. The participants, who had low back pain for more than three months, were divided into two groups: a treatment group and a waitlist control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- The StimaWELL 120MTRS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 29 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old,
- LBP for more than three months,
- Pain of 3 or more according to the Numeric Pain Scale
- being literate
Who cannot join
- having a pacemaker,
- body mass index greater than 30,
- pathologies of the cervical or lumbar region,
- cervical radiculopathy, thoracic outlet syndrome, malignant conditions,
- systemic diseases, such as neurological, psychological, cardiovascular or rheumatologic conditions, loss of function due to these diseases,
- history of surgery on the spine or upper extremities,
- acute infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Electrotherapy Treatment for the Spine in Individuals with Chronic Low Back Pain
This study investigates the effectiveness of a specific electrotherapy treatment for individuals with chronic non-specific low back pain. The participants, who had low back pain for more than three months, were divided into two groups: a treatment group and a waitlist control group. The treatment group received electrotherapy using the StimaWELL 120MTRS system, which provided electrical stimulation and heat therapy to the entire spine over four weeks. The study assessed various outcomes, including pain levels, disability, and quality of life, before and after the intervention.
- Conditions
- Chronic Low Back Pain
- Being tested
- The StimaWELL 120MTRS system
- Keywords
- chronic low back pain, electrotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The StimaWELL 120MTRS systemDevice
A standardized current (dynamic deep wave stimulation) was applied to all patients. Additionally, the mat, which reached a temperature of 40°C, provided heat therapy with electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| StimaWell | Experimental | Participants in the StimaWELL group had previously received electrotherapy treatment for the entire spine for 4 weeks, 2 days a week. Before the treatment, participants were informed about their medical condition and the planned treatment. The StimaWELL 120MTRS system (StimaWELL® 120MTRS; Schwa-medico, Wetzlarer Straße 41-43, 35630 Ehringshausen, Germany) was used for the treatment and a stimulation mat was used to apply electrical stimulation along the entire back. The 12 channels of the mat provided different current intensities to different areas and the system offered programs tailored to various therapeutic goals. Receives: Device: The StimaWELL 120MTRS system |
| Waitlist | No intervention | Patients presenting to the clinic for treatment and waiting without intervention in the waitlist group after routine evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Catastrophizing Scale
Participants' pain catastrophizing levels were measured using the Pain Catastrophizing Scale (PCS). The total score of the PCS is 52, with higher scores indicating higher levels of catastrophizing behavior.
Measured: Before and after 4 weeks of treatment
Secondary outcomes (3)
Numeric Pain Scale
Pain intensity during activity, at rest and at night was assessed with the Numeric Pain Scale. It was graded with "0" representing "no pain" and "10" representing "the worst pain imaginable".
Measured: Before and after 4 weeks of treatment
Oswestry Disability Index
Disability level was assessed with the Oswestry Disability Index. The scale consists of 10 items, each ranging from 0 to 5, with a total score of 100. Higher scores indicate higher levels of disability.
Measured: Before and after 4 weeks of treatment
Nottingham Health Profile
The Nottingham Health Profile was used to assess participants' health-related quality of life. The first part of the NHP contains 38 items covering six domains: pain, physical activity, emotional reactions, energy, social isolation and sleep. Each domain is scored from 0 to 100 and the total score is the sum of these domain scores. Only the first part of the NHP was used for this study
Measured: Before and after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Aug 2023
- Primary completion29 Feb 2024
- Study completion29 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 Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Ulger, Hacettepe University
- Investigators
- Özlem Ülger, professor, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638229
- Sponsor's protocol ID
- HUSpine017
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oz M, Asliyuce YO, Fanuscu A, Ulger O. Effectiveness of whole spine electrotherapy in individuals with chronic low back pain: a retrospective controlled study. Pain Manag. 2026 Jul 31:1-10. doi: 10.1080/17581869.2026.2710353. Online ahead of print.
PubMed 42535459
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Electrotherapy Treatment for the Spine in Individuals with Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06638229
- Acronym / sponsor ID
- HUSpine017
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, electrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 15 Oct 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 investigates the effectiveness of a specific electrotherapy treatment for individuals with chronic non-specific low back pain. The participants, who had low back pain for more than three months, were divided into two groups: a treatment group and a waitlist control group. The treatment group received electrotherapy using the StimaWELL 120MTRS system, which provided electrical stimulation and heat therapy to the entire spine over four weeks. The study assessed various outcomes, including pain levels, disability, and quality of life, before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StimaWell | Experimental | Device: The StimaWELL 120MTRS systemParticipants in the StimaWELL group had previously received electrotherapy treatment for the entire spine for 4 weeks, 2 days a week. Before the treatment, participants were informed about their medical condition and the planned treatment. The StimaWELL 120MTRS system (StimaWELL® 120MTRS; Schwa-medico, Wetzlarer Straße 41-43, 35630 Ehringshausen, Germany) was used for the treatment and a stimulation mat was used to apply electrical stimulation along the entire back. The 12 channels of the mat provided different current intensities to different areas and the system offered programs tailored to various therapeutic goals. |
| Waitlist | No intervention | –Patients presenting to the clinic for treatment and waiting without intervention in the waitlist group after routine evaluation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old,
- LBP for more than three months,
- Pain of 3 or more according to the Numeric Pain Scale
- being literate
Key exclusion criteria (7 listed)
- having a pacemaker,
- body mass index greater than 30,
- pathologies of the cervical or lumbar region,
- cervical radiculopathy, thoracic outlet syndrome, malignant conditions,
- systemic diseases, such as neurological, psychological, cardiovascular or rheumatologic conditions, loss of function due to these diseases,
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 |
|---|---|---|
| The StimaWELL 120MTRS systemA standardized current (dynamic deep wave stimulation) was applied to all patients. Additionally, the mat, which reached a temperature of 40°C, provided heat therapy with electrical stimulation | Device | StimaWell |
Primary outcome
Pain Catastrophizing Scale
Time frame: Before and after 4 weeks of treatment
Participants' pain catastrophizing levels were measured using the Pain Catastrophizing Scale (PCS). The total score of the PCS is 52, with higher scores indicating higher levels of catastrophizing behavior.
3 secondary outcomes
Numeric Pain Scale
Time frame: Before and after 4 weeks of treatment
Oswestry Disability Index
Time frame: Before and after 4 weeks of treatment
Nottingham Health Profile
Time frame: Before and after 4 weeks of treatment
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 Jan 2025.
- Derived from this study: PubMed 42535459Oz M, Asliyuce YO, Fanuscu A, Ulger O. Effectiveness of whole spine electrotherapy in individuals with chronic low back pain: a retrospective controlled study. Pain Manag. 2026 Jul 31:1-10. doi: 10.1080/17581869.2026.2710353. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Low Back Pain
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Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic 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.
Özlem Ülger, professor principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The StimaWELL 120MTRS system in people with Chronic Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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 Jan 2025. 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 Turkey (Türkiye). 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?
Pain Catastrophizing Scale (time frame: Before and after 4 weeks of treatment). 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 NCT06638229, 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 20 Jan 2025.