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| Name | Class |
|---|---|
| Beijing University of Chinese Medicine | OTHER |
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The study aims to assess the efficacy and safety of acupuncture among patients with chronic nonspecific neck pain and insomnia, compared with sham acupuncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture group | Experimental | Participants in the acupuncture group will receive treatment at DU 20 [Baihui], EX-HN15 [Jingbailao], GB 12 [Wangu], Shangyintang (On the head, 1 B-cun superior to Yintang), HT7 [Shenmen], KI 3 [Taixi] and Ashi Point. The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 4 weeks. |
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| Sham acupuncture (SA) group | Sham Comparator | Participants in the SA group will receive treatment at sham DU 20, sham EX-sham HN15, sham GB 12, sham Shangyintang , sham HT7 and sham KI 3. The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | The needles will be inserted to 12.5-30 mm in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week | The NRS score ranges from 0 to 10, with higher scores indicating more severe pain. | week 5 |
| The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores. | The Chinese version of the Insomnia Severity Index (ISI-C) will be used to assess the severity of patients' self-perceived insomnia symptoms. Each item is rated on a scale from 0 to 4, with a total score ranging from 0 to 28. Based on the total score, the severity of insomnia can be categorized into four levels: a score of 0-7 indicates "no clinically significant insomnia," 8-14 indicates "subclinical insomnia," 15-21 indicates "clinical insomnia (moderate)," and 22-28 indicates "clinical insomnia (severe)." | week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week | The NRS score ranges from 0 to 10, with higher scores indicating more severe pain. | week 9 and 16 |
| The change from baseline in the ISI-C scores. |
| Measure | Description | Time Frame |
|---|---|---|
| Expectance assessment | Patients wIll be asked to predict how their chronic neck pain will change in one month (much better, somewhat better, uncertain, somewhat worse, much worse); and how their insomnia will change (much better, somewhat better, uncertain, somewhat worse, much worse). | baseline |
| Incidence of advers events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhishun Liu | Contact | +861088002331 | zhishunjournal@163.com | |
| SIXING LIU | Contact | +8613521617871 | sixingliu@sina.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Guangxia Shi | Beijing University of Chinese Meidicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42110592 | Derived | Liu S, Chen H, Shen X, Lun H, Fan J, Wang W, Shi G, Liu Z. Acupuncture for Comorbid Chronic Nonspecific Neck Pain and Chronic Insomnia: Protocol for a Multicenter, Randomized, Sham-Controlled Trial. J Pain Res. 2026 Apr 17;19:598575. doi: 10.2147/JPR.S598575. eCollection 2026. |
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Deidentified participant data and data dictionary will be available with the publication until six months after publication.
A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.
Researchers whose proposal has been approved will sign a data access agreement.
The data will be available with the publication until six months after publication.
A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved.
Researchers whose proposal has been approved will sign a data access agreement.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| sham acupuncture | Device | The needle will be inserted to 2-3mm in sham Baihui acupoint. For the remaining sham acupoints, needles will be inserted into the pad and reaching the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effect of the needle tip penetrating the skin. |
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The ISI-C will be used to assess the severity of patients' self-perceived insomnia symptoms. Each item is rated on a scale from 0 to 4, with a total score ranging from 0 to 28. Based on the total score, the severity of insomnia can be categorized into four levels: a score of 0-7 indicates "no clinically significant insomnia," 8-14 indicates "subclinical insomnia," 15-21 indicates "clinical insomnia (moderate)," and 22-28 indicates "clinical insomnia (severe)."
| week 9 and 16 |
| The proportion of participants with at least 30% reduction in NRS scores from baseline | The NRS score ranges from 0 to 10, with higher scores indicating more severe pain. | week 5, 9 and 16 |
| The proportion of participants with at least 6 points reduction in ISI-C scores from baseline | The ISI-C will be used to assess the severity of patients' self-perceived insomnia symptoms. Each item is rated on a scale from 0 to 4, with a total score ranging from 0 to 28. Based on the total score, the severity of insomnia can be categorized into four levels: a score of 0-7 indicates "no clinically significant insomnia," 8-14 indicates "subclinical insomnia," 15-21 indicates "clinical insomnia (moderate)," and 22-28 indicates "clinical insomnia (severe)." | week 5, 9 and 16 |
| The change from baseline in the total score of the Neck Disability Index (NDI). | Neck Disability Index (NDI) consists of 10 items, with a total score ranging from 0 to 50. A higher score indicates a greater impact of neck pain on quality of life. | week 5, 9 and 16 |
| The proportion of participants with at least 10 points reduction in NDI scores from baseline | NDI consists of 10 items, with a total score ranging from 0 to 50. A higher score indicates a greater impact of neck pain on quality of life. | week 5, 9 and 16 |
| The change from baseline in the maximum pain intensity score on the NRS during six directions of neck movement. | The NRS score ranges from 0 to 10, with higher scores indicating more severe pain. | week 5, 9 and 16 |
| The change from baseline in the Pittsburgh Sleep Quality Index (PSQI). | The PSQI has a total score ranging from 0 to 21. A higher score indicates poorer sleep quality. Specifically, a total score of 0-5 indicates very good sleep quality; 6-10 indicates fairly good sleep quality; 11-15 indicates average sleep quality; and 16-21 indicates poor sleep quality. | week 5, 9 and 16 |
| The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores. | The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression. | week 5, 9 and 16 |
| The proportion of responders per the Patient Global Impression of Change (PGI-C) | The PGI-C evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "moderately better, "a little better", "no change", "a little worse", "moderately worse" or "very much worse". | week 5 and 16 |
| The percentage of patients who used rescue analgesics and sedative-hypnotics. | The percentage of patients who used emergency analgesics and sedative-hypnotics. | week 5, 9 and 16 |
| The total number of days of using rescue analgesics and sedative-hypnotics. | The total number of days of using rescue analgesics and sedative-hypnotics. | week 5, 9 and 16 |
| Blinding assessment | In this trial, two types of acupuncture treatments were used: traditional acupuncture, which has a stronger sensation of needle insertion, and modern acupuncture, which has a weaker sensation of needle insertion. Patients were asked which type of therapy they thought they had received. | Within 5 minutes after the last treatment at week 4. |
Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not. |
| through study completion, an average of 16 weeks |
| D001523 |
| Mental Disorders |