Electro-thumbtack Needle Therapy for Chronic Neck Pain
2026年8月6日 更新者：Shi Hangyu
Efficacy and Safety of Electro-thumbtack Needle Therapy for Patients With Chronic Neck Pain: a Randomized, Placebo-controlled Trial
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
180
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beijing、中国
- Guang'anmen Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
他の名前：
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偽コンパレータ：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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of participants with an at least 50% decrease in NRS-NP from baseline.
時間枠：week 4
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Rate pain intensity by 11 numbers from 0 (no pain at all) to 10 (worst pain imaginable)
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week 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change of NRS-NP from baseline.
時間枠：week 4, 16, 28
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Rate pain intensity by 11 numbers from 0 (no pain at all) to 10 (worst pain imaginable)
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week 4, 16, 28
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Proportion of participants with an at least 50% decrease in NRS-NP from baseline.
時間枠：week 16, 28
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Rate pain intensity by 11 numbers from 0 (no pain at all) to 10 (worst pain imaginable)
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week 16, 28
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Proportion of participants with an at least 30% decrease in NRS-NP from baseline.
時間枠：week 4, 16, 28
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Rate pain intensity by 11 numbers from 0 (no pain at all) to 10 (worst pain imaginable)
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week 4, 16, 28
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Change of NPQ from baseline.
時間枠：week 4, 16, 28
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NPQ is a validated questionnaire to learn about the quality and the duration of neck pain and the difficulty coping with chores because of the pain.
It contains 9 questions, each ranging from 0 to 4. The total score will be converted to NPQ percentage score (divided by 36 for people who drive and by 32 for those who don't), which ranges from 0 to 100%.
High scores indicate worse condition.
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week 4, 16, 28
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Proportion of participants with an at least 25% decrease in NPQ from baseline and a "better" or "much better" for global effectiveness rating.
時間枠：week 4, 16, 28
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NPQ is a validated questionnaire to learn about the quality and the duration of neck pain and the difficulty coping with chores because of the pain.
It contains 9 questions, each ranging from 0 to 4. The total score will be converted to NPQ percentage score (divided by 36 for people who drive and by 32 for those who don't), which ranges from 0 to 100%.
High scores indicate worse condition.
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week 4, 16, 28
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Change of NDI from baseline.
時間枠：week 4, 16, 28
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NDI is a widely used instrument to measure self-reporting disability due to neck pain.
It consists of 10 items scored with an ordinal scale from 0-5.
The total score ranges from 0-50.
Higher scores indicate greater functional limitation.
The translated simplified-Chinese version of NDI has been shown to be a responsive and valid measurement for simplified-Chinese speaking patients.
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week 4, 16, 28
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Proportion of participants with an at least 10-point decrease in NDI from baseline.
時間枠：week 4, 16, 28
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NDI is a widely used instrument to measure self-reporting disability due to neck pain.
It consists of 10 items scored with an ordinal scale from 0-5.
The total score ranges from 0-50.
Higher scores indicate greater functional limitation.
The translated simplified-Chinese version of NDI has been shown to be a responsive and valid measurement for simplified-Chinese speaking patients.
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week 4, 16, 28
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Degree of PGIC.
時間枠：week 4, 28
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Characterize the participants' overall satisfaction and personal feelings about treatment delivery.
The options are ranking from "very much worse" to "very much improved" for patients to define their overall status compared with the start of the study.
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week 4, 28
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-expectation assessment.
時間枠：baseline
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Participants will be asked "How do you think your neck pain will be after 4 weeks?" for self-expectation, the answers are "worse", "unchanged", "no idea", "better", "much better".
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baseline
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Preference of ETN assessment.
時間枠：baseline
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Participants will be asked"Do you think ETN will be effective for chronic neck pain?" for preference of ETN, the answers are "not effective", "little effective", "not sure", "effective", "very effective".
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baseline
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Blinding assessment.
時間枠：week 4
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All participants will be told before allocation that insertion is deeper in ETN group and shallower in sham ETN group, the electric stimulation is weak or just about to feel in both groups.
After treatments finished, they will be asked "Do you think you have received ETN in the past weeks?", the answers are "Yes", "No" or "Unclear".
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week 4
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Proportion of participants taking rescue medication.
時間枠：week 0 to 28
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Any other therapy will be discouraged during this trial.
If the neck pain occurs heavily or unbearably, acetaminophen (sustained release type, 500 mg/T) will be provided as rescue medication.
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week 0 to 28
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Total days of participants demanding rescue medication.
時間枠：week 0 to 28
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Any other therapy will be discouraged during this trial.
If the neck pain occurs heavily or unbearably, acetaminophen (sustained release type, 500 mg/T) will be provided as rescue medication.
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week 0 to 28
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Hangyu Shi、Guang'anmen Hospital of China Academy of Chinese Medical Sciences
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年6月6日
一次修了 (実際)
2024年7月13日
研究の完了 (実際)
2025年1月15日
試験登録日
最初に提出
2021年7月18日
QC基準を満たした最初の提出物
2021年7月18日
最初の投稿 (実際)
2021年7月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月10日
QC基準を満たした最後の更新が送信されました
2026年8月6日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2021-039-KY-01
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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