Electro-thumbtack Needle Therapy for Chronic Neck Pain

Shi Hangyu

Status: Unknown

Conditions: Neck Pain

Treatments: Procedure: Sham electro-thumbtack needle therapy; Procedure: Electro-thumbtack Needle Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04981171

2021-039-KY-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups

Electro-thumbtack Needle Therapy (ETN) group

Experimental group

Description:

Electro-thumbtack needles (0.25×2 mm) will be inserted into acupoints of Dazhui (GV14), bilateral Wangu (GB12), bilateral cervical Jiaji (at C4 and C6 level), two Ashi points and bilateral Houxi (SI3) after sterilization. Then apply the gel electrodes and stimulation devices, turn on the device to produce a proper electric stimulation that the participant can tolerate.

Treatment:

Procedure: Electro-thumbtack Needle Therapy

Sham Electro-thumbtack Needle Therapy (ETN) group

Sham Comparator group

Description:

Sham electro-thumbtack needles (0.25×0.2 mm) which are specially produced have blunt tips instead of sharp needle tip. They will be taped on acupoints of Dazhui (GV14), bilateral Wangu (GB12), bilateral cervical Jiaji (at C4 and C6 level), two Ashi points and bilateral Houxi (SI3) after sterilization. Then apply the gel electrodes and stimulation devices, produce a minimal level of electric stimulation for 30 seconds before turning off the device.

Treatment:

Procedure: Sham electro-thumbtack needle therapy