Acute Effects of Transcutaneous Electrical Nerve Stimulation on Passive Muscle Stiffness and Pain in Patients With Neck Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in upper trapezius dynamic stiffness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to group allocation. Participants are not blinded when the comparator is "no intervention." If a sham TENS comparator is used, participants will also be blinded (double-blind: participant and outcomes assessor). Randomization is concealed using sequentially numbered, opaque, sealed envelopes (SNOSE); assessors do not have access to the allocation list.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
TENS
Participants receive a single session of conventional TENS targeting painful/stiff cervical muscle regions (typically upper trapezius ± suboccipital) with immediate post-session assessments.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
TENS
Participants receive a single session of conventional TENS targeting painful/stiff cervical muscle regions (typically upper trapezius ± suboccipital) with immediate post-session assessments.
干预措施: Sham TENS (Device)
Sham TENS
Participants undergo a sham stimulation session with identical setup and timing to mimic TENS without delivering therapeutic current.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
Sham TENS
Participants undergo a sham stimulation session with identical setup and timing to mimic TENS without delivering therapeutic current.
干预措施: Sham TENS (Device)
结局指标
主要结局
Change in upper trapezius dynamic stiffness
时间窗: 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).
次要结局
- Change in pain intensity(T0 and immediately post-session)
研究者
esedullah akaras
Dr.
Erzurum Technical University