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Abstract Background Neuropathic pain is a common complication in neuromyelitis optica spectrum disorder (NMOSD), which seriously affects the quality of life of NMOSD patients, with no satisfactory treatment. Through the previous literature study and clinical observation, we found that acupuncture has good curative effect in the treatment of pain, especially electric acupuncture, but thestudies on acupuncture intervention in pain of NMOSD are still scare.
Objective To evaluate the clinical efficacy of electroacupuncture on NMOSD patients with pain.
Materials and Methods In this exploratory randomized controlled study, NMOSD patients with pain were recruited from March 21, 2022 to February 21, 2023. Patients meeting the inclusion and exclusion criteria were randomly assigned to the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group) by simple random method (envelope method) according to the inclusion order. Totally, there are 20 patients enrolled.
The experimental group received electroacupuncture therapy and the control group received sham electroacupuncture therapy. A total of 8 sessions were given twice a week for 30 minutes each. On the baseline, demographic information, medication history, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected, the brain, cervical and thoracic MRI were perfected and collected, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SDS, EDSS. After the treatment, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected again, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SD, EDSS. The main outcome indicators were SF-MPQ, and the secondary outcome indicators were EDSS, NRS, SAS, SDS, SF-36, IL-6, and TNF-α.
Conclusion This is the first exploratory randomized controlled study to evaluate the efficacy of electroacupuncture on pain in patients with NMOSD. The study will provide clincial evidence of the practice of electroacupuncture on NMOSD with pain.
Key Words neuromyelitis optica spectrum disorders; pain; electroacupuncture
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the electroacupuncture group | Experimental | electroacupuncture were inserted into bilateral Zusanli (ST36), Sanyinjiao (SP6), Hegu (LI4) and Quchi (LI11), and Yintang (EX-HN3). Electroacupuncture parameters selected the sparse wave, the frequency was 4 Hz, the stimulation intensity was tolerated by the patient. |
|
| the sham electroacupuncture group | Sham Comparator | According to the previous trial,[19] sham acupoints were 1cm away from the level of the acupoints used in the EA group, which avoided the area corresponding to any of the 14 meridians of TCM. The insertion of the needle was shallower (less than 0.2cm) and had similar pain to that of normal needle insertion. The stimulation intensity was 0mA. However, the model of electroacupuncture, the frequency, and duration of treatment in the SEA group were identical in the TA group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroacupuncture | Behavioral | electroacupuncture were inserted into bilateral Zusanli (ST36), Sanyinjiao (SP6), Hegu (LI4) and Quchi (LI11), and Yintang (EX-HN3). Electroacupuncture parameters selected the sparse wave, the frequency was 4 Hz, the stimulation intensity was tolerated by the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Short-Form of McGill Pain Questionnaire(SF - MPQ) | higher scores mean a worse outcome. | on the baseline |
| Short-Form of McGill Pain Questionnaire(SF - MPQ) | higher scores mean a worse outcome. | through study completion, an average of 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Disability Status Scale(EDSS) | higher scores mean a worse outcome. | on the baseline |
| Expanded Disability Status Scale(EDSS) | higher scores mean a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhao yuan qi, Dr | Guangdong Provincial Hospital of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2022 | May 6, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2022 | May 6, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group)
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|
| through study completion, an average of 1 month |
| numerical rating scale(NRS) | higher scores mean a worse outcome. | on the baseline |
| numerical rating scale(NRS) | higher scores mean a worse outcome. | through study completion, an average of 1 month |
| Self-Rating Anxiety Scale (SAS) | higher scores mean a worse outcome. | on the baseline |
| Self-Rating Anxiety Scale (SAS) | higher scores mean a worse outcome. | through study completion, an average of 1 month |
| Self-rating Depression Scale (SDS) | higher scores mean a worse outcome. | on the baseline |
| Self-rating Depression Scale (SDS) | higher scores mean a worse outcome. | through study completion, an average of 1 month |
| 36-item Short-Form (SF-36) | higher scores mean a better outcome. | on the baseline |
| 36-item Short-Form (SF-36) | higher scores mean a better outcome. | through study completion, an average of 1 month |
| Interleukin-6 (IL-6) | higher scores mean a worse outcome. | on the baseline |
| Interleukin-6 (IL-6) | higher scores mean a worse outcome. | through study completion, an average of 1 month |
| tumor necrosis factor-α (TNF-α) | higher scores mean a worse outcome. | on the baseline |
| tumor necrosis factor-α (TNF-α) | higher scores mean a worse outcome. | through study completion, an average of 1 month |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |