Clinical trial NCT04981171: Electro-thumbtack Needle Therapy for Chronic Neck Pain
Official title: Efficacy and Safety of Electro-thumbtack Needle Therapy for Patients With Chronic Neck Pain: a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective trial will be a single-center, participant-blinded, randomized controlled trial. It is reported in previous studies that both acupuncture and transcutaneous electrical nerve stimulation are effective in reducing neck pain comparing to placebo or exercise. Taking into account the convenience of electro-thumbtack needle therapy shown in clinical practice, this study aims to evaluate the efficacy and safety of electro-thumbtack needle therapy for alleviating chronic neck pain compared with sham electro-thumbtack needle therapy.

Detailed description: Chronic neck pain is a commonly experienced symptom that often influences work efficiency and life satisfaction for years. A total of 180 participants suffering mechanical chronic neck pain will be recruited and randomized into either electro-thumbtack needle therapy group or sham electro-thumbtack needle therapy group. All participants will receive the standardized neck exercise instruction at their first treatment session and will be asked to perform the exercise once every day during 4-week treatment. All assessments will be performed by the assessor and the assessment results will be all kept from the acupuncturist. The statistician will be involved in neither assessment nor treatment and will be blinded regarding intervention group code.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with neck pain with headaches or neck pain with movement coordination impairments according to the Orthopaedic Section of the American Physical Therapy Association (APTA);
2. Aaged 18-65 years;
3. History of neck pain for at least 3 months;
4. A score of ≥4 in Numerical Rating Scale for neck pain (NRS-NP) assessing the average neck pain intensity over last 7 days until the day of recruitment.

Exclusion Criteria:

1. Diagnosed with neck pain with mobility deficits or neck pain with radiating pain according to the Orthopaedic Section, APTA;
2. Known specific reason leading to neck pain such as tumor, immune disease, endocrine and metabolic disorders, neurological abnormalities, cervical vertebra fracture, cervical dislocation;
3. Acute neck pain or neck pain with radiating pain or upper limb symptoms;
4. Neck pain with sensory or motor disturbance;
5. Prior cervical spine surgery or congenital abnormalities;
6. Experiencing medical dispute litigation;
7. Have received acupuncture in last 30 days;
8. In need of analgesic, muscle relaxant, hormones, or bearing greater pain from another area;
9. Allergic to metal or adhesive tape, or carrying cardiac pacemaker, or skin damaged at selected acupoints;
10. Disable to communicate or critically ill;
11. Drug or alcohol dependent;
12. Currently or planning to be pregnant.

Primary outcomes:
measure: Proportion of participants with an at least 50% decrease in NRS-NP from baseline.
timeFrame: week 4
Secondary outcomes:
measure: Change of NRS-NP from baseline.
timeFrame: week 4, 16, 28
measure: Proportion of participants with an at least 50% decrease in NRS-NP from baseline.
timeFrame: week 16, 28
measure: Proportion of participants with an at least 30% decrease in NRS-NP from baseline.
timeFrame: week 4, 16, 28
measure: Change of NPQ from baseline.
timeFrame: week 4, 16, 28
measure: Proportion of participants with an at least 25% decrease in NPQ from baseline and a "better" or "much better" for global effectiveness rating.
timeFrame: week 4, 16, 28
measure: Change of NDI from baseline.
timeFrame: week 4, 16, 28
measure: Proportion of participants with an at least 10-point decrease in NDI from baseline.
timeFrame: week 4, 16, 28
measure: Degree of PGIC.
timeFrame: week 4, 28
Other outcomes:
measure: Self-expectation assessment.
timeFrame: baseline
measure: Preference of ETN assessment.
timeFrame: baseline
measure: Blinding assessment.
timeFrame: week 4
measure: Proportion of participants taking rescue medication.
timeFrame: week 0 to 28
measure: Total days of participants demanding rescue medication.
timeFrame: week 0 to 28
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Hangyu Shi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi H, Wang X, Yan Y, Zhu L, Chen Y, Gao S, Liu Z. Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled Trial. Front Med (Lausanne). 2022 Apr 29;9:872362. doi: 10.3389/fmed.2022.872362. eCollection 2022.