Neck Pain Chronic
Conditions
Keywords
chronic neck pain, sEMG, acupuncture, randomized controlled trial
Brief summary
The goal of this clinical trial is to determine whether acupuncture can improve neck pain and shoulder movement in people with chronic neck pain. Researchers will compare acupuncture with sham acupuncture (a procedure designed to resemble acupuncture without therapeutic effects) to determine whether acupuncture provides specific benefits. Participants will be randomly assigned to receive either acupuncture or sham acupuncture. They will attend 1 treatment session and undergo assessments of neck and shoulder movement, muscle activity, pain intensity, and neck-related disability before and after treatment. Researchers will also monitor any adverse events associated with treatment.
Detailed description
The goal of this clinical trial is to learn whether acupuncture can improve neck and shoulder function in patients with chronic neck pain. It will also evaluate the effects of acupuncture on scapular movement, muscle activity, pain intensity, and neck-related disability. The main questions it aims to answer are: Does acupuncture improve muscle activation onset time in patients with chronic neck pain? Does acupuncture change electromyographic activity of the neck and shoulder muscles? Does acupuncture reduce pain intensity and neck-related disability? Researchers will compare real acupuncture with sham acupuncture to determine whether the observed effects are specifically related to acupuncture treatment. Participants will: Be randomly assigned to receive either real acupuncture or sham acupuncture Receive one treatment session over the study intervention period. Undergo assessments of muscle activation onset time and electromyographic activity before and after treatment Complete questionnaires evaluating pain intensity, neck disability, and related symptoms Attend follow-up assessments and report any adverse events during the study period.
Interventions
OTHERAcupuncture
Participants receive standardized acupuncture treatment administered by licensed acupuncturists. Disposable sterile needles are inserted at predefined acupuncture points selected for chronic neck pain management. Manual needle stimulation is applied to elicit deqi sensation, and needles are retained for approximately 20-30 minutes per session. Treatments are delivered according to a standardized protocol throughout the study period.
OTHERSham Acupuncture
Participants receive sham acupuncture using non-penetrating placebo needles that simulate needle insertion without skin penetration. The sham procedure is performed at predefined non-acupuncture locations and follows the same treatment frequency, duration, and clinical procedures as the acupuncture group. The intervention is designed to maintain participant blinding while minimizing specific physiological effects associated with acupuncture.
Sponsors
Hualien Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants were blinded to treatment allocation and informed that they would receive one of two forms of acupuncture intervention. Outcome assessors responsible for collecting clinical, kinematic, and electromyographic data were blinded to group assignment. Data analysis was performed using coded group labels to maintain blinding until completion of the primary analyses. Acupuncturists delivering the interventions were not blinded because of the nature of the treatment procedures.
Intervention model description
Eligible participants are randomly allocated in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. Both groups receive treatment according to their assigned intervention throughout the study period. Outcomes, including scapular kinematics, electromyographic activity, pain intensity, and neck disability, are assessed at predefined time points. No crossover between groups is permitted.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age between 18 and 65 years; * presence of neck discomfort for at least 3 months; and * baseline neck disability index(NDI) score between 5 and 24, indicating mild to moderate disability, and baseline Numerical Rating Scale (NRS) score between 1 and 6 for pain intensity.
Exclusion criteria
* scored \>24 on the NDI, indicating severe disability; * had a history of neck, shoulder, or upper limb surgery or major trauma; * had restricted shoulder joint ROM, joint instability, or shoulder pain during movement; * had taken analgesics, muscle relaxants, anti-inflammatory agents, or traditional Chinese or Western medicine 3 days prior to study initiation; * had received acupuncture, massage, cupping, or other manual therapies within 1 week prior to the intervention; and/or * were pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective outcome (Range of Motion of the Cervical and Shoulder Joints) | Baseline and immediately after completion of the intervention period. | The primary outcome variables were the ROM of the cervical and shoulder joints, muscle tension, and muscle activation onset time measured using surface electromyography (sEMG). 1\. Range of Motion (ROM) of the Cervical and Shoulder Joints Cervical ROM (flexion, extension, and bilateral side-bending) and shoulder ROM (flexion, external rotation and internal rotation on the affected side) were measured using a standard universal goniometer. |
| Objective outcome (Muscle Tension Measurement) | Baseline and immediately after completion of the intervention period. | 2\. Muscle Tension Measurement Passive mechanical properties of the muscles (upper trapezius \[UT\], lower trapezius \[LT\], and middle deltoid \[MiD\]) were evaluated using a handheld digital myotonometer (MyotonPRO, Myoton AS, Tallinn, Estonia). |
| Objective outcome (Muscle Activation Onset Time) | Baseline and immediately after completion of the intervention period | Muscle activation onset time of the upper trapezius \[UT\], lower trapezius \[LT\], and middle deltoid \[MiD\], and serratus anterior (SA) during shoulder scaption was evaluated via Surface Electromyography (sEMG) (Noraxon USA Inc, Scottsdale, AZ). All procedures followed the sEMG for the Non-Invasive Assessment of Muscles recommendations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Outcomes (Numerical Rating Scale) | The participants completed the Numerical Rating Scale at baseline and on days 7 and 14 post-intervention. | We used self-reported Numerical Rating Scale scores (from 0 to 10)to assess pain intensity of neck before and after treatment. |
| Subjective Outcomes (Neck Disability Index) | The participants completed the Neck Disability Index questionnaire at baseline and on days 7 and 14 post-intervention. | We used self-reported Neck Disability Index scores to assess neck disability before and after treatment |
Countries
Taiwan
Outcome results
None listed