Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT07244861
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-24
First Post:
2025-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of TENS on Cervical Muscle Stiffness and Pain in Neck Pain
Sponsor:
Erzurum Technical University
Organization:
Study Overview
Official Title:
Acute Effects of Transcutaneous Electrical Nerve Stimulation on Passive Muscle Stiffness and Pain in Patients With Neck Pain: A Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENS-NECK
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Erzurum Technical University | OTHER | Erzurum Technical University | View |