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This study will be an evaluation of the efficacy and safety of acupuncture for cervical spondylotic radiculopathy. The main questions it aims to answer are 1. Does acupuncture improve the pain intensity among patients with cervical spondylotic radiculopathy? 2. Does acupuncture treat cervical spondylotic radiculopathy safely? Researchers will compare acupuncture to sham acupuncture to see if acupuncture could improve symptoms among patients with cervical spondylotic radiculopathy. Experimental and control groups will be treated with 6 weeks of acupuncture or sham-acupuncture respectively. Patients were followed up at 1 month, 3 months, 6 months after treatment to record outcome, any disease progression, adverse events, and so on.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | Acupuncture group received 3 acupuncture treatment sessions per week (every 1 or 2 days) over 6 weeks, 18 sessionsin total. The main acupuncture points are Jingbailao (EX-HN15), Jingjiaji (EX-B2), Binao (LI14) and Ashi. And according to the symptoms, select from the following acupoints: Wangu (GB12), Shouwuli (LI13), Quchi (LI11), Hegu (LI4), Zhongzhu (TE3) and Waiguan (TE5). |
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| Sham acupuncture group | Sham Comparator | Sham acupuncture group received 3 sham acupuncture treatment sessions per week (every 1 or 2 days) over 6 weeks, 18 sessionsin total. The main acupuncture points are Jingbailao (EX-HN15), Jingjiaji (EX-B2), Binao (LI14) and Ashi. And according to the symptoms, select from the following acupoints: Wangu (GB12), Shouwuli (LI13), Quchi (LI11), Hegu (LI4), Zhongzhu (TE3) and Waiguan (TE5). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | The needles will be inserted 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 |
|---|---|---|
| Clinical response rate | Average NRS (numerical rating scale) score of arm pain decreased by at least 30% compared with baseline in the past 24 hours. | At 6 weeks from randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| The average NRS (numerical rating scale) score of arm pain in the past 24 hours as change from baseline. | At 1,3,6,10,18,30 weeks from randomization. | |
| The average NRS (numerical rating scale) score of neck pain in the past 24 hours as change from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of belief in acupuncture | Participants will be asked: Do you think your cervical spondylotic radiculopathy may be helped by acupuncture? | Baseline assessment (week 0) |
| Blinding assessment Description |
Inclusion Criteria:
Exclusion Criteria:
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Deidentified participant data and data dictionary will be available with the publication until six months after publication.
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A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| sham acupuncture | Device | The 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. |
|
| At 1,3,6,10,18,30 weeks from randomization. |
| Clinical response rate | NRS (numerical rating scale) score of arm pain decreased by at least 30% compared with baseline in the past 24 hours. | At 1,3,10,18,30 weeks from randomization. |
| Clinical response rate | NRS (numerical rating scale) score of neck pain decreased by at least 30% compared with baseline in the past 24 hours. | At 1,3,6,10,18,30 weeks from randomization. |
| The NDI (Neck Disability Index) score as change from baseline. | At 3,6,10,18,30 weeks from randomization. |
| Percentage of patients with NDI (Neck Disability Index) score lower than baseline by 8.5 points or more. | At 3,6,10,18,30 weeks from randomization. |
| NRS (numerical rating scale) score of the maximum neck/arm pain during neck exercise as change from baseline. | At 1,3,6,10,18,30 week from randomization. |
| ISI-C (Insomnia Severity Index) score as change from baseline. | At 6,10,18,30 weeks from randomization. |
| PHQ-9 (Patient Health Questionnaire-9) score as change from baseline. | At 3,6,10,18,30 weeks from randomization. |
| GAD-7 (Generalized Anxiety Disorder-7) score as change from baseline. | At 3,6,10,18,30 weeks from randomization. |
| EQ-5D-5L score as change from baseline. | At 6,10,18,30 weeks from randomization. |
| Patient Global Impression of Change, PGIC | 1 means great improvement of arm pain, 2 means moderate improvement of arm pain, 3 means better of arm pain, 4 means no change of arm pain, 5 means slight deterioration of arm pain, 6 means moderate deterioration of arm pain and 7 means much deterioration of arm pain. | At 6,30 weeks from randomization. |
| Percentage of emergency painkillers used in the past week. | At 1,3,6,10,18,30 weeks from randomization. |
| The total number of days of using emergency painkillers in the past week. | At 1,3,6,10,18,30 weeks from randomization. |
| Adverse event | Collect the adverse reactions related to acupuncture, such as needle breakage, local hematoma, infection and abscess, and any unexpected symptoms, signs or health conditions during the experiment. | At 1,3,6,10,18,30 weeks from randomization. |
Participants will be asked: Do you think you have received traditional acupuncture in the past 6 weeks?
| Within 5 minutes after either treatment at week 6. |