Low Back PainTENS-LUMBARNCT07242235
Immediate Effects of TENS on Lumbar Erector Spinae Stiffness in Low Back Pain
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Low Back Pain and Non-specific Low Back Pain, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is frequently associated with increased tone and stiffness of the lumbar erector spinae muscles, which may contribute to pain and functional limitation. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, safe, and widely used modality for pain reduction, but its very short-term… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Non-specific Low Back Pain, Lumbar Muscle Stiffness
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-30 years
- Non-specific low back pain persisting or recurring for ≥3 months
- Reported tenderness/stiffness on palpation of the lumbar erector spinae muscles
- Able to understand the study procedures and provide written informed consent
- Able to attend on the same day for TENS application and pre-/post-intervention measurements
Who cannot join
- Low back pain with a specific cause (e.g. lumbar disc herniation with radiculopathy, infection, tumor, fracture, severe deformity)
- Open wound, dermatitis, or any skin condition in the lumbar area that prevents electrode placement
- Presence of a cardiac pacemaker or other implanted electronic device
- Electrotherapy, injection, or manual therapy applied to the lumbar region within the previous 48 hours
- Pregnancy
- Severe neurological deficit or sensory loss
- Use of analgesics/NSAIDs at a level that may interfere with pain or stiffness assessment at the time of evaluation
- Any other condition deemed unsafe or inappropriate by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzurum Technical University
Erzurum
Furgani Taş, Mr, 445388 ext. 2049, furgani.tas@erzurum.edu.tr
About this study
Official title: Immediate Effects of Transcutaneous Electrical Nerve Stimulation on the Lumbar Erector Spinae Muscles' Stiffness and Pain: A Randomized Controlled Trial
Low back pain is frequently associated with increased tone and stiffness of the lumbar erector spinae muscles, which may contribute to pain and functional limitation. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, safe, and widely used modality for pain reduction, but its very short-term (immediate) effects on lumbar muscle stiffness have not been clearly demonstrated. This randomized controlled trial will compare a single 20-minute session of conventional TENS with a control/rest condition in patients with non-specific low back pain. The primary outcomes will be change in lumbar erector spinae muscle stiffness (Myoton) and change in pain intensity (VAS) from baseline to immediately after the intervention. We hypothesize that TENS will produce a greater immediate reduction in muscle stiffness and pain than control.
Read the detailed description
Low back pain (LBP) is one of the most common musculoskeletal problems and often presents with increased paraspinal muscle activity and perceived stiffness around the lumbar region. Increased stiffness of the lumbar erector spinae may perpetuate pain and restrict movement. TENS provides afferent stimulation that can modulate pain through gate-control and descending inhibitory mechanisms and may secondarily reduce muscle tone. However, evidence about its acute influence on objective muscle stiffness parameters in LBP is limited.
This single-center, parallel-group, randomized controlled trial will recruit adults with chronic or recurrent non-specific low back pain who meet the eligibility criteria. Participants will be randomly assigned (1:1) to (1) an experimental group receiving conventional TENS applied bilaterally over the lumbar paraspinal area for 20 minutes (frequency ~80-100 Hz, pulse width ~100-150 μs), or (2) a control group undergoing the same positioning and timing without active TENS. All assessments will be performed immediately before and immediately after the intervention by an outcome assessor blinded to group allocation.
Primary outcomes are: (a) lumbar erector spinae muscle stiffness measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels, and (b) pain intensity measured with a 10-cm visual analog scale (VAS). Secondary observations may include participant-reported comfort/tolerance of TENS and adverse events. The study is designed as a short-term physiological and symptomatic trial; no long-term follow-up is planned. Ethical approval was obtained from the Erzurum Technical University Ethics Committee (Meeting 13, Decision 04, 18.09.2025)
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- TENS, Low Back Pain, Muscle Stiffness, Randomized Controlled Trial
- 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.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called Rest/Observation
Conventional TENS; frequency 80-100 Hz, pulse width 100-150 μs, intensity adjusted to strong but comfortable sensory level without muscle contraction; total duration 20 minutes; electrodes placed bilaterally at lumbar erector spinae level.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: TENS | Experimental | Participants receive a single 30-minute session of conventional TENS applied bilaterally over the lumbar paraspinal (erector spinae) region. Pre- and post-intervention Myoton and VAS measurements are taken. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Control: Rest/Positioning | Other | Participants are positioned in the same way and remain at rest for 20 minutes without active TENS. Pre- and post-intervention Myoton and VAS measurements are taken. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lumbar erector spinae muscle stiffness
Muscle stiffness of the lumbar erector spinae will be measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels. The outcome is the change score (post - pre) between TENS and control groups. Lower values indicate reduced stiffness.
Measured: Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
Change in pain intensity (VAS)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst pain). The outcome is the change score (post - pre) to compare TENS and control groups. Lower scores indicate pain reduction.
Measured: Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start25 Nov 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Dec 2025 (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.
- 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
- Participants will be randomized (1:1) to active TENS or control/rest; both groups are assessed pre- and immediately post-intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- Amasya University
- Responsible party
- Principal investigator, esedullah akaras, Erzurum Technical University
- Investigators
- Gökhan YAĞIZ, Dr., Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242235
- Sponsor's protocol ID
- ETU-TENS-LBP-01
- Acronym
- TENS-LUMBAR
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is small, single-center, and includes identifiable clinical measurements that could risk participant privacy despite de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Transcutaneous Electrical Nerve Stimulation on the Lumbar Erector Spinae Muscles' Stiffness and Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07242235
- Acronym / sponsor ID
- TENS-LUMBAR / ETU-TENS-LBP-01
- Keywords
- TENS, Low Back Pain, Muscle Stiffness, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Collaborators
- Amasya University
- Study start
- 25 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Nov 2025 (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.
Low back pain is frequently associated with increased tone and stiffness of the lumbar erector spinae muscles, which may contribute to pain and functional limitation. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, safe, and widely used modality for pain reduction, but its very short-term (immediate) effects on lumbar muscle stiffness have not been clearly demonstrated. This randomized controlled trial will compare a single 20-minute session of conventional TENS with a control/rest condition in patients with non-specific low back pain. The primary outcomes will be change in lumbar erector spinae muscle stiffness (Myoton) and change in pain intensity (VAS) from baseline to immediately after the intervention. We hypothesize that TENS will produce a greater immediate reduction in muscle stiffness and pain than control.
Detailed description
Low back pain (LBP) is one of the most common musculoskeletal problems and often presents with increased paraspinal muscle activity and perceived stiffness around the lumbar region. Increased stiffness of the lumbar erector spinae may perpetuate pain and restrict movement. TENS provides afferent stimulation that can modulate pain through gate-control and descending inhibitory mechanisms and may secondarily reduce muscle tone. However, evidence about its acute influence on objective muscle stiffness parameters in LBP is limited.
This single-center, parallel-group, randomized controlled trial will recruit adults with chronic or recurrent non-specific low back pain who meet the eligibility criteria. Participants will be randomly assigned (1:1) to (1) an experimental group receiving conventional TENS applied bilaterally over the lumbar paraspinal area for 20 minutes (frequency ~80-100 Hz, pulse width ~100-150 μs), or (2) a control group undergoing the same positioning and timing without active TENS. All assessments will be performed immediately before and immediately after the intervention by an outcome assessor blinded to group allocation.
Primary outcomes are: (a) lumbar erector spinae muscle stiffness measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels, and (b) pain intensity measured with a 10-cm visual analog scale (VAS). Secondary observations may include participant-reported comfort/tolerance of TENS and adverse events. The study is designed as a short-term physiological and symptomatic trial; no long-term follow-up is planned. Ethical approval was obtained from the Erzurum Technical University Ethics Committee (Meeting 13, Decision 04, 18.09.2025)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized (1:1) to active TENS or control/rest; both groups are assessed pre- and immediately post-intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental: TENS | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants receive a single 30-minute session of conventional TENS applied bilaterally over the lumbar paraspinal (erector spinae) region. Pre- and post-intervention Myoton and VAS measurements are taken. |
| Control: Rest/Positioning | Other | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants are positioned in the same way and remain at rest for 20 minutes without active TENS. Pre- and post-intervention Myoton and VAS measurements are taken. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-30 years
- Non-specific low back pain persisting or recurring for ≥3 months
- Reported tenderness/stiffness on palpation of the lumbar erector spinae muscles
- Able to understand the study procedures and provide written informed consent
- Able to attend on the same day for TENS application and pre-/post-intervention measurements
Key exclusion criteria (8 listed)
- Low back pain with a specific cause (e.g. lumbar disc herniation with radiculopathy, infection, tumor, fracture, severe deformity)
- Open wound, dermatitis, or any skin condition in the lumbar area that prevents electrode placement
- Presence of a cardiac pacemaker or other implanted electronic device
- Electrotherapy, injection, or manual therapy applied to the lumbar region within the previous 48 hours
- 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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: Rest/ObservationConventional TENS; frequency 80-100 Hz, pulse width 100-150 μs, intensity adjusted to strong but comfortable sensory level without muscle contraction; total duration 20 minutes; electrodes placed bilaterally at lumbar erector spinae level. | Device | Control: Rest/Positioning, Experimental: TENS |
Primary outcome
Change in lumbar erector spinae muscle stiffness
Time frame: Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
Muscle stiffness of the lumbar erector spinae will be measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels. The outcome is the change score (post - pre) between TENS and control groups. Lower values indicate reduced stiffness.
Change in pain intensity (VAS)
Time frame: Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst pain). The outcome is the change score (post - pre) to compare TENS and control groups. Lower scores indicate pain reduction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is small, single-center, and includes identifiable clinical measurements that could risk participant privacy despite de-identification.
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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.
Gökhan YAĞIZ, Dr. principal investigator
Amasya 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 Transcutaneous Electrical Nerve Stimulation (TENS) in people with Low Back Pain and Non-specific Low Back Pain, run by Erzurum Technical 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 5 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: opening soon, as of the sponsor's last update on 21 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esedullah AKARAS, Dr. (4445388 ext. 2772, esedullah.akaras@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lumbar erector spinae muscle stiffness (time frame: Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)). 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 21 Nov 2025.