Electro-thumbtack Needle Therapy for Chronic Neck Pain

NCT ID: NCT04981171

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-03
• Study Completion Date: 2023-12-31

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Electro-thumbtack Needle Therapy (ETN) group

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.

Group Type: EXPERIMENTAL

Electro-thumbtack Needle Therapy

Intervention Type: PROCEDURE

Each treatment session starts with sterilizing acupoints. Dazhui (GV14), bilateral Wangu (GB12), bilateral cervical Jiaji (at C4 and C6 level), two Ashi points and bilateral Houxi (SI3) have been selected in accordance with the principle of acupuncture prescription making and the consensus of experts on treating neck pain. Electro-thumbtack needles (0.25×2 mm) will be held by the acupuncturist between thumb and forefinger, vertically inserted into skin instantly and taped well on skin. Then assemble the gel electrodes to the surface of the conductive adhesive tape, also assemble the portable stimulation devices, adjust the current intensity from level 1 to a proper level that the participant can tolerate. Participants will receive three 30-min treatment sessions per week every other day for 4 consecutive weeks.

Sham Electro-thumbtack Needle Therapy (ETN) group

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.

Group Type: SHAM_COMPARATOR

Sham electro-thumbtack needle therapy

Intervention Type: PROCEDURE

Each treatment session starts with sterilizing acupoints. Sham electro-thumbtack needles (0.25×0.2 mm) will be held by the acupuncturist between thumb and forefinger, taped well on skin without penetration. The adhesive tape of needles are also produced with conductive material, after assembling the gel electrodes and the portable stimulation devices, adjust the current intensity to level 1 for a minimal stimulus which will last for only 30 seconds. By this time the acupuncturist will turn the device off to cut the current. Participants will receive three 30-min treatment sessions per week every other day for 4 consecutive weeks.

Interventions

Electro-thumbtack Needle Therapy

Each treatment session starts with sterilizing acupoints. Dazhui (GV14), bilateral Wangu (GB12), bilateral cervical Jiaji (at C4 and C6 level), two Ashi points and bilateral Houxi (SI3) have been selected in accordance with the principle of acupuncture prescription making and the consensus of experts on treating neck pain. Electro-thumbtack needles (0.25×2 mm) will be held by the acupuncturist between thumb and forefinger, vertically inserted into skin instantly and taped well on skin. Then assemble the gel electrodes to the surface of the conductive adhesive tape, also assemble the portable stimulation devices, adjust the current intensity from level 1 to a proper level that the participant can tolerate. Participants will receive three 30-min treatment sessions per week every other day for 4 consecutive weeks.

Intervention Type: PROCEDURE

Sham electro-thumbtack needle therapy

Each treatment session starts with sterilizing acupoints. Sham electro-thumbtack needles (0.25×0.2 mm) will be held by the acupuncturist between thumb and forefinger, taped well on skin without penetration. The adhesive tape of needles are also produced with conductive material, after assembling the gel electrodes and the portable stimulation devices, adjust the current intensity to level 1 for a minimal stimulus which will last for only 30 seconds. By this time the acupuncturist will turn the device off to cut the current. Participants will receive three 30-min treatment sessions per week every other day for 4 consecutive weeks.

Intervention Type: PROCEDURE

Other Intervention Names

ETN; Sham ETN

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shi Hangyu

OTHER

Sponsor Role: lead

Responsible Party

Shi Hangyu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hangyu Shi

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Central Contacts

Hangyu Shi

Role: CONTACT

shihangyutcm@163.com

+8618811735839

References

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.

Reference Type: DERIVED

PMID: 35572961 (View on PubMed)

Other Identifiers

2021-039-KY-01

Identifier Type: -

Identifier Source: org_study_id