Neuromyelitis Optica Spectrum DisordersNCT05871658
Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol
A study testing electroacupuncture in people with Neuromyelitis Optica Spectrum Disorders and Pain, run by Yuanqi Zhao,MD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders, Pain
- What is being tested?
- electroacupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2022to 21 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people diagnosed as NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria.[21]
- NRS≥4.
- people were treated with stable doses of biological therapy and/or prednisone, with no regimen adjustment within 30 days prior to enrollment.
- people did not adjust any standard pain medication combinations, including antiepileptic drugs, antidepressants, and opioids, within 30 days before enrollment.
- people or their families provided written informed consent.
Who cannot join
- people enrolled in other clinical studies.
- people with low cognitive or mental ability.
- people who became pregnant during the study period, breastfed, or planned to become pregnant.
- people with serious diseases related to the heart, liver, kidney or hematopoietic system.
- people with diabetic peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510000
About this study
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.
Read more
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
- Conditions
- Neuromyelitis Optica Spectrum Disorders, Pain
- Being tested
- electroacupuncture
- Medical subject headings
- Neuromyelitis Optica, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: electroacupuncture |
| 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. Receives: Behavioral: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-Form of McGill Pain Questionnaire(SF - MPQ)
higher scores mean a worse outcome.
Measured: on the baseline
Short-Form of McGill Pain Questionnaire(SF - MPQ)
higher scores mean a worse outcome.
Measured: through study completion, an average of 1 month
Secondary outcomes (14)
Expanded Disability Status Scale(EDSS)
higher scores mean a worse outcome.
Measured: on the baseline
Expanded Disability Status Scale(EDSS)
higher scores mean a worse outcome.
Measured: through study completion, an average of 1 month
numerical rating scale(NRS)
higher scores mean a worse outcome.
Measured: on the baseline
numerical rating scale(NRS)
higher scores mean a worse outcome.
Measured: through study completion, an average of 1 month
Self-Rating Anxiety Scale (SAS)
higher scores mean a worse outcome.
Measured: on the baseline
Self-Rating Anxiety Scale (SAS)
higher scores mean a worse outcome.
Measured: through study completion, an average of 1 month
Self-rating Depression Scale (SDS)
higher scores mean a worse outcome.
Measured: on the baseline
Self-rating Depression Scale (SDS)
higher scores mean a worse outcome.
Measured: through study completion, an average of 1 month
36-item Short-Form (SF-36)
higher scores mean a better outcome.
Measured: on the baseline
36-item Short-Form (SF-36)
higher scores mean a better outcome.
Measured: through study completion, an average of 1 month
Interleukin-6 (IL-6)
higher scores mean a worse outcome.
Measured: on the baseline
Interleukin-6 (IL-6)
higher scores mean a worse outcome.
Measured: through study completion, an average of 1 month
tumor necrosis factor-α （TNF-α）
higher scores mean a worse outcome.
Measured: on the baseline
tumor necrosis factor-α （TNF-α）
higher scores mean a worse outcome.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start21 Mar 2022
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuanqi Zhao,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanqi Zhao,MD, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Zhao yuan qi, Dr, Study director, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871658
- Sponsor's protocol ID
- 20230221
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol
- ClinicalTrials.gov ID
- NCT05871658
- Acronym / sponsor ID
- 20230221
- Conditions
- Neuromyelitis Optica Spectrum Disorders, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yuanqi Zhao,MDUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group)
| Arm | Type | Receives |
|---|---|---|
| the electroacupuncture group | Experimental | Behavioral: electroacupunctureelectroacupuncture 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 | Behavioral: electroacupunctureAccording 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- people diagnosed as NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria.[21]
- NRS≥4.
- people were treated with stable doses of biological therapy and/or prednisone, with no regimen adjustment within 30 days prior to enrollment.
- people did not adjust any standard pain medication combinations, including antiepileptic drugs, antidepressants, and opioids, within 30 days before enrollment.
- people or their families provided written informed consent.
Key exclusion criteria (5 listed)
- people enrolled in other clinical studies.
- people with low cognitive or mental ability.
- people who became pregnant during the study period, breastfed, or planned to become pregnant.
- people with serious diseases related to the heart, liver, kidney or hematopoietic system.
- people with diabetic peripheral neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupunctureelectroacupuncture 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. | Behavioural | the electroacupuncture group, the sham electroacupuncture group |
Primary outcome
Short-Form of McGill Pain Questionnaire(SF - MPQ)
Time frame: on the baseline
higher scores mean a worse outcome.
Short-Form of McGill Pain Questionnaire(SF - MPQ)
Time frame: through study completion, an average of 1 month
higher scores mean a worse outcome.
14 secondary outcomes
Expanded Disability Status Scale(EDSS)
Time frame: on the baseline
Expanded Disability Status Scale(EDSS)
Time frame: through study completion, an average of 1 month
numerical rating scale(NRS)
Time frame: on the baseline
numerical rating scale(NRS)
Time frame: through study completion, an average of 1 month
Self-Rating Anxiety Scale (SAS)
Time frame: on the baseline
Self-Rating Anxiety Scale (SAS)
Time frame: through study completion, an average of 1 month
Self-rating Depression Scale (SDS)
Time frame: on the baseline
Self-rating Depression Scale (SDS)
Time frame: through study completion, an average of 1 month
36-item Short-Form (SF-36)
Time frame: on the baseline
36-item Short-Form (SF-36)
Time frame: through study completion, an average of 1 month
Interleukin-6 (IL-6)
Time frame: on the baseline
Interleukin-6 (IL-6)
Time frame: through study completion, an average of 1 month
tumor necrosis factor-α （TNF-α）
Time frame: on the baseline
tumor necrosis factor-α （TNF-α）
Time frame: through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao yuan qi, Dr study director
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Neuromyelitis Optica Spectrum Disorders and Pain, run by Yuanqi Zhao,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Form of McGill Pain Questionnaire(SF - MPQ) (time frame: on the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.