Neck PainTENS-NECKNCT07244861
Acute Effects of TENS on Cervical Muscle Stiffness and Pain in Neck Pain
A study testing Transcutaneous Electrical Nerve Stimulation in people with Neck Pain and Chronic Neck Pain, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigates the acute effects of transcutaneous electrical nerve stimulation (TENS) on passive cervical muscle stiffness (MyotonPro "dynamic stiffness", N/m) and pain (0-10 VAS) in adults with chronic/mechanical neck pain. Participants will be allocated 1:1 to TENS or control/sham. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Neck Pain, Chronic Neck Pain, Muscle Stiffness
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Sep 2025to 15 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years.
- Neck pain VAS ≥ 3/10 at screening and on test day.
- Clinical diagnosis of chronic or mechanical neck pain (≥6 weeks).
- Able to understand study procedures and provide written informed consent.
- Willing to refrain from analgesics/muscle relaxants and vigorous neck/shoulder exercise for 24 hours before testing.
Who cannot join
- Cervical radiculopathy or neurological signs (myotomal weakness, dermatomal sensory loss, reflex changes).
- Recent invasive procedures to the neck/shoulder (e.g., surgery, injections, radiofrequency/neurotomy) within 6 weeks.
- Pacemaker/implantable cardioverter, or other active implanted electronic device.
- Pregnancy or planning pregnancy.
- Skin conditions at electrode sites (open wounds, infection, severe dermatitis) or known allergy to electrode adhesive/gel.
- History of epilepsy or unexplained syncope.
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- Acute neck trauma (<6 weeks) or red flags (fracture, malignancy, infection, inflammatory rheumatic disease).
- Systemic disorders likely to affect outcomes (e.g., uncontrolled diabetes with neuropathy, severe cardiovascular disease, fibromyalgia with widespread pain).
- Ongoing electrotherapy to the neck region or botulinum toxin injections to cervical muscles within 3 months.
- Inability to comply with procedures (e.g., severe communication/cognitive impairment), or insufficient proficiency in Turkish to complete measures.
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 Faculty of Health Sciences
Erzurum
About this study
Official title: Acute Effects of Transcutaneous Electrical Nerve Stimulation on Passive Muscle Stiffness and Pain in Patients With Neck Pain: A Randomized Controlled Trial
This randomized controlled trial investigates the acute effects of transcutaneous electrical nerve stimulation (TENS) on passive cervical muscle stiffness (MyotonPro "dynamic stiffness", N/m) and pain (0-10 VAS) in adults with chronic/mechanical neck pain. Participants will be allocated 1:1 to TENS or control/sham. Outcomes are measured immediately before and immediately after a single 15-minute session.
Read the detailed description
Background/Rationale: TENS modulates superficial afferent input and may reduce pain and muscle tone. However, its immediate impact on objective passive muscle stiffness measured by a handheld myotonometer (MyotonPro) in neck pain is insufficiently characterized. This trial tests whether a brief, low-risk intervention produces measurable changes in mechanical muscle properties and perceived pain in a short time window.
Objectives/Hypotheses:
Primary objective: Determine whether conventional TENS acutely reduces dynamic stiffness of the upper trapezius compared with control/sham.
Secondary objectives: Evaluate pain (VAS), additional MyotonPro parameters (frequency/tone, logarithmic decrement, relaxation time, creep), and safety/tolerability.
Hypothesis: TENS will show a significant group × time interaction favoring TENS over control/sham.
Design: Single-center (optionally multi-center), parallel-group, randomized (1:1) RCT. Masking: at minimum outcome assessor-blinded; participant blinding if sham TENS is used.
Sample Size: n = 24 (12 per arm), based on a priori power analysis (f≈0.40, α=0.05, power=0.95) for a 2×2 mixed design.
Intervention (TENS): Conventional mode; ~80 Hz, ≤150 µs pulse width; 15 minutes; intensity "strong but tolerable" without visible muscle contraction. Electrodes placed over the most painful/stiff segments (typically upper trapezius and/or suboccipital region), preferably bilateral.
Control/Sham: No intervention or sham TENS (electrodes applied; intensity raised to sensation then reduced below perception/zero; device indicators remain on).
Assessments \& Timing:
Time points: T0 (pre-session), T1 (immediately post-session).
Primary outcome: Upper trapezius dynamic stiffness (N/m)-three repetitions averaged at a standardized anatomical landmark.
Secondary outcomes: Pain VAS (0-10); MyotonPro frequency/tone, decrement, relaxation time, creep on upper trapezius ± SCM ± cervical extensors; adverse events/tolerability. (Neck Disability Index may be collected at baseline for descriptive characterization.)
Statistical Plan: Mixed-effects repeated-measures analysis with Group (TENS vs control/sham) × Time (T0 vs T1); assumption checks with robust alternatives/transformations as needed; multiple-comparison controls; effect sizes reported.
Eligibility (summary): Adults 18-50 years with neck pain VAS ≥3/10. Key exclusions include pacemaker, pregnancy, recent invasive procedures (≤6 weeks), significant dermatologic issues at electrode sites, cervical radiculopathy/neurological signs, acute neck injury. (Full list in Eligibility.)
Safety: Low-risk, non-invasive procedure. Expected adverse effects are minor (e.g., transient discomfort or skin irritation). AE/SAE monitoring is prospective; the session will be stopped if intolerable symptoms occur.
- Conditions
- Neck Pain, Chronic Neck Pain, Muscle Stiffness, Transcutaneous Electrical Nerve Stimulation
- Being tested
- Transcutaneous Electrical Nerve Stimulation, Sham TENS
- Keywords
- TENS, MyotonPro, VAS pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
Also called Conventional TENS; TENS therapy
Conventional mode TENS, frequency ~80 Hz, pulse width ≤150 µs, duration 20 minutes. Intensity set to "strong but tolerable" without visible muscle contraction. Electrodes placed bilaterally over the most painful/stiff segments (e.g., upper trapezius midpoint along C7-acromion line; adjustments per comfort
Sham TENSDevice
Also called Placebo TENS
Electrodes applied at the same anatomical sites as the active arm. Device indicators remain on; intensity is ramped to perception briefly and then reduced to sub-sensory/zero so that no effective current is delivered for the remainder of the 20-minute session. Procedures and clinician-participant interactions mirror the active arm
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | Participants receive a single session of conventional TENS targeting painful/stiff cervical muscle regions (typically upper trapezius ± suboccipital) with immediate post-session assessments. Receives: Device: Transcutaneous Electrical Nerve Stimulation; Device: Sham TENS |
| Sham TENS | Sham comparator | Participants undergo a sham stimulation session with identical setup and timing to mimic TENS without delivering therapeutic current. Receives: Device: Transcutaneous Electrical Nerve Stimulation; Device: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper trapezius dynamic stiffness
Passive muscle dynamic stiffness (N/m) measured with MyotonPro at a standardized landmark on the upper trapezius (midpoint along the C7-acromion line; side = most symptomatic or bilateral mean).
Measured: Pre-session (T0) and immediately post-session (T1; within 5 minutes of session end)
Secondary outcomes (1)
Change in pain intensity
0-10 Visual Analog Scale for current neck pain (0 = no pain, 10 = worst imaginable).
Measured: T0 and immediately post-session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start23 Sep 2025
- Primary completion10 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck 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
- Two parallel arms with 1:1 allocation (TENS vs control/sham). Randomization is computer-generated with allocation concealment using sequentially numbered, opaque, sealed envelopes (SNOSE). Outcomes are assessed pre-session and immediately post-session in a single visit. Outcome assessors are blinded; participant blinding is applied if the sham TENS arm is used.
- 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, Bangor University, Ataturk University
- Responsible party
- Principal investigator, esedullah akaras, Erzurum Technical University
- Investigators
- Gökhan YAGİZ, Dr., Study director, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244861
- Sponsor's protocol ID
- ETU-TENS-NECK-RCT-02
- Other IDs
- Erzurum Technical University
- Acronym
- TENS-NECK
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified IPD (outcomes, baseline demographics, allocation, adverse events) will be shared \~6 months after primary completion for 36 months via an institutional repository or encrypted transfer managed by Erzurum Technical University.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Transcutaneous Electrical Nerve Stimulation on Passive Muscle Stiffness and Pain in Patients With Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07244861
- Acronym / sponsor ID
- TENS-NECK / ETU-TENS-NECK-RCT-02
- Conditions
- Neck Pain, Chronic Neck Pain, Muscle Stiffness, Transcutaneous Electrical Nerve Stimulation
- Keywords
- TENS, MyotonPro, VAS pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Collaborators
- Amasya University, Bangor University, Ataturk University
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 24 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.
This randomized controlled trial investigates the acute effects of transcutaneous electrical nerve stimulation (TENS) on passive cervical muscle stiffness (MyotonPro "dynamic stiffness", N/m) and pain (0-10 VAS) in adults with chronic/mechanical neck pain. Participants will be allocated 1:1 to TENS or control/sham. Outcomes are measured immediately before and immediately after a single 15-minute session.
Detailed description
Background/Rationale: TENS modulates superficial afferent input and may reduce pain and muscle tone. However, its immediate impact on objective passive muscle stiffness measured by a handheld myotonometer (MyotonPro) in neck pain is insufficiently characterized. This trial tests whether a brief, low-risk intervention produces measurable changes in mechanical muscle properties and perceived pain in a short time window.
Objectives/Hypotheses:
Primary objective: Determine whether conventional TENS acutely reduces dynamic stiffness of the upper trapezius compared with control/sham.
Secondary objectives: Evaluate pain (VAS), additional MyotonPro parameters (frequency/tone, logarithmic decrement, relaxation time, creep), and safety/tolerability.
Hypothesis: TENS will show a significant group × time interaction favoring TENS over control/sham.
Design: Single-center (optionally multi-center), parallel-group, randomized (1:1) RCT. Masking: at minimum outcome assessor-blinded; participant blinding if sham TENS is used.
Sample Size: n = 24 (12 per arm), based on a priori power analysis (f≈0.40, α=0.05, power=0.95) for a 2×2 mixed design.
Intervention (TENS): Conventional mode; ~80 Hz, ≤150 µs pulse width; 15 minutes; intensity "strong but tolerable" without visible muscle contraction. Electrodes placed over the most painful/stiff segments (typically upper trapezius and/or suboccipital region), preferably bilateral.
Control/Sham: No intervention or sham TENS (electrodes applied; intensity raised to sensation then reduced below perception/zero; device indicators remain on).
Assessments \& Timing:
Time points: T0 (pre-session), T1 (immediately post-session).
Primary outcome: Upper trapezius dynamic stiffness (N/m)-three repetitions averaged at a standardized anatomical landmark.
Secondary outcomes: Pain VAS (0-10); MyotonPro frequency/tone, decrement, relaxation time, creep on upper trapezius ± SCM ± cervical extensors; adverse events/tolerability. (Neck Disability Index may be collected at baseline for descriptive characterization.)
Statistical Plan: Mixed-effects repeated-measures analysis with Group (TENS vs control/sham) × Time (T0 vs T1); assumption checks with robust alternatives/transformations as needed; multiple-comparison controls; effect sizes reported.
Eligibility (summary): Adults 18-50 years with neck pain VAS ≥3/10. Key exclusions include pacemaker, pregnancy, recent invasive procedures (≤6 weeks), significant dermatologic issues at electrode sites, cervical radiculopathy/neurological signs, acute neck injury. (Full list in Eligibility.)
Safety: Low-risk, non-invasive procedure. Expected adverse effects are minor (e.g., transient discomfort or skin irritation). AE/SAE monitoring is prospective; the session will be stopped if intolerable symptoms occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms with 1:1 allocation (TENS vs control/sham). Randomization is computer-generated with allocation concealment using sequentially numbered, opaque, sealed envelopes (SNOSE). Outcomes are assessed pre-session and immediately post-session in a single visit. Outcome assessors are blinded; participant blinding is applied if the sham TENS arm is used.
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: Transcutaneous Electrical Nerve Stimulation, Device: Sham TENSParticipants receive a single session of conventional TENS targeting painful/stiff cervical muscle regions (typically upper trapezius ± suboccipital) with immediate post-session assessments. |
| Sham TENS | Sham comparator | Device: Transcutaneous Electrical Nerve Stimulation, Device: Sham TENSParticipants undergo a sham stimulation session with identical setup and timing to mimic TENS without delivering therapeutic current. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-50 years.
- Neck pain VAS ≥ 3/10 at screening and on test day.
- Clinical diagnosis of chronic or mechanical neck pain (≥6 weeks).
- Able to understand study procedures and provide written informed consent.
- Willing to refrain from analgesics/muscle relaxants and vigorous neck/shoulder exercise for 24 hours before testing.
Key exclusion criteria (10 listed)
- Cervical radiculopathy or neurological signs (myotomal weakness, dermatomal sensory loss, reflex changes).
- Recent invasive procedures to the neck/shoulder (e.g., surgery, injections, radiofrequency/neurotomy) within 6 weeks.
- Pacemaker/implantable cardioverter, or other active implanted electronic device.
- Pregnancy or planning pregnancy.
- Skin conditions at electrode sites (open wounds, infection, severe dermatitis) or known allergy to electrode adhesive/gel.
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 StimulationAlso: Conventional TENS; TENS therapyConventional mode TENS, frequency ~80 Hz, pulse width ≤150 µs, duration 20 minutes. Intensity set to "strong but tolerable" without visible muscle contraction. Electrodes placed bilaterally over the most painful/stiff segments (e.g., upper trapezius midpoint along C7-acromion line; adjustments per comfort | Device | Sham TENS, TENS |
| Sham TENSAlso: Placebo TENSElectrodes applied at the same anatomical sites as the active arm. Device indicators remain on; intensity is ramped to perception briefly and then reduced to sub-sensory/zero so that no effective current is delivered for the remainder of the 20-minute session. Procedures and clinician-participant interactions mirror the active arm | Device | Sham TENS, TENS |
Primary outcome
Change in upper trapezius dynamic stiffness
Time frame: Pre-session (T0) and immediately post-session (T1; within 5 minutes of session end)
Passive muscle dynamic stiffness (N/m) measured with MyotonPro at a standardized landmark on the upper trapezius (midpoint along the C7-acromion line; side = most symptomatic or bilateral mean).
1 secondary outcome
Change in pain intensity
Time frame: T0 and immediately post-session
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 24 Nov 2025.
- Individual participant dataSharing planned: No. De-identified IPD (outcomes, baseline demographics, allocation, adverse events) will be shared ~6 months after primary completion for 36 months via an institutional repository or encrypted transfer managed by Erzurum Technical University.
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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 YAGİZ, Dr. study director
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 in people with Neck Pain and Chronic Neck 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 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: enrolling by invitation, as of the sponsor's last update on 24 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. 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?
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?
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 upper trapezius dynamic stiffness (time frame: Pre-session (T0) and immediately post-session (T1; within 5 minutes of session end)). 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 24 Nov 2025.