Electro-thumbtack Needle Therapy for Chronic Neck Pain

NCT04981171 | Unknown

• 1 other identifier: 2021-039-KY-01
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with an at least 50% decrease in NRS-NP from baseline.

  Rate pain intensity by 11 numbers from 0 (no pain at all) to 10 (worst pain imaginable)

  week 4

Secondary Outcomes (8)

• Change of NRS-NP from baseline.

  week 4, 16, 28

• Proportion of participants with an at least 50% decrease in NRS-NP from baseline.

  week 16, 28

• Proportion of participants with an at least 30% decrease in NRS-NP from baseline.

  week 4, 16, 28

• Change of NPQ from baseline.

  week 4, 16, 28

• Proportion of participants with an at least 25% decrease in NPQ from baseline and a "better" or "much better" for global effectiveness rating.

  week 4, 16, 28

Other Outcomes (5)

• Self-expectation assessment.

  baseline

• Preference of ETN assessment.

  baseline

• Blinding assessment.

  week 4

Study Arms (2)

Electro-thumbtack Needle Therapy (ETN) group

EXPERIMENTAL

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.

Procedure: Electro-thumbtack Needle Therapy

Sham Electro-thumbtack Needle Therapy (ETN) group

SHAM COMPARATOR

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.

Procedure: Sham electro-thumbtack needle therapy

Interventions

Electro-thumbtack Needle Therapy 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.

Also known as: ETN

Electro-thumbtack Needle Therapy (ETN) group

Sham electro-thumbtack needle therapy 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.

Also known as: Sham ETN

Sham Electro-thumbtack Needle Therapy (ETN) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Aaged 18-65 years;
• History of neck pain for at least 3 months;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shi Hangyu: lead

Related Publications (1)

• 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.

  PMID: 35572961 DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hangyu Shi

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hangyu Shi

CONTACT

+8618811735839; shihangyutcm@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 28, 2021
• Study Start: April 3, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03