Enhancing chronic migraine preventive therapy: laser acupuncture as an add-on treatment for patients with unsatisfactory pharmacological effect
| ISRCTN | ISRCTN11208146 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11208146 |
- Submission date
- 17/01/2024
- Registration date
- 19/01/2024
- Last edited
- 02/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Laser acupuncture is a proven non-invasive treatment with effects comparable to traditional acupuncture in chronic pain diseases, and it exhibits fewer adverse effects in treating headaches. However, recent studies lack sufficient evidence to support its application in chronic migraine (CM) in adults. This study aims to investigate the efficacy and safety of laser acupuncture (LA) as an add-on preventive therapy for CM.
Who can participate?
Adult patients with CM aged over 18 years old who have unsatisfactory pharmacological effects
What does the study involve?
In this study, participants will be randomly assigned to either LA or a sham control procedure, aiming to investigate the efficacy and safety of LA as an add-on preventive therapy for CM.
What are the possible benefits and risks of participating?
Participants with poor-controlled CM may benefit by having their pharmacological treatment effect enhanced by add-on LA preventive therapy. There are risks of any of the following adverse events occurring during LA, such as nausea, dizziness, local paresthesia, local heat sensation, fatigue, somnolence, and ecchymosis.
Where is the study run from?
Taichung Veterans General Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
January 2022 to December 2023
Who is funding the study?
Department of Traditional Chinese Medicine, Taichung Veterans General Hospital. This research did not receive any specific grants from public, commercial, or not-for-profit funding agencies.
Who is the main contact?
1. Chi-Sheng Wang, sam7227632@gmail.com
Contact information
Public, Scientific, Principal Investigator
Taichung Veterans General Hospital
No. 1650, Taiwan Boulevard, Sec. 4
Taichung City
40705
Taiwan
 ORCID ID |
0000-0003-0842-9875 |
|---|---|
| Phone | +886933375721 |
| saintchi@vghtc.gov.tw |
Public, Scientific, Principal Investigator
Taichung Veterans General Hospital
No. 1650, Taiwan Boulevard, Sec. 4
Taichung City
40705
Taiwan
| Phone | +886933375721 |
|---|---|
| sam7227632@gmail.com |
Study information
| Study design | Single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Laser acupuncture for chronic migraine Participants: Chronic migraine (CM) patients with unsatisfactory pharmacological effects Intervention: Laser acupuncture (LA) as an add-on preventive therapy Comparisons: Sham treatment as a control group Outcomes: Changes in monthly migraine days (MMD) and acute headache medications usage days per month from baseline |
| Study hypothesis | Laser acupuncture enhances the pharmacological treatment effect as an add-on preventive therapy for individuals with poor-controlled CM |
| Ethics approval(s) |
Approved 04/05/2022, Institutional Review Board I &II of Taichung Veterans General Hospital (No. 1650, Taiwan Boulevard, Sec. 4, Taichung, 407219, Taiwan; +886-4-23592525 #4006; irbtc@vghtc.gov.tw), ref: CF22082B |
| Condition | Chronic migraine |
| Intervention | This study is a single-blind randomized controlled trial, conducted from January 2022 to November 2023, aimed to investigate the efficacy and safety of laser acupuncture (LA) as an add-on preventive therapy for chronic migraine (CM) in patients with unsatisfactory pharmacological effects. The intervention comprises non-invasive laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3). Participants were randomized by computer software (Excel 2016 for Windows). Study arms: Experimental: laser acupuncture CM patients with unsatisfactory pharmacological effects receive laser acupuncture for 8 sessions that spanned 4 weeks. Device intervention: Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3) Sham Comparator: Sham treatment Sham treatment had no laser output. Device intervention: Sham treatment with no laser output, stimulate the same acupoints as the laser acupuncture group as follows: 30 seconds at bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3) Follow-up activity. After completing the study and unblinding, we will provide authentic laser acupuncture to individuals randomized to the Sham group. Intervention provider The laser application procedures will be performed by the same experienced physician who was a well-trained and licensed Chinese medicine practitioner in Taiwan. The execution process adhered to the regulations of the Taiwan Ministry of Health and Welfare. Modes of delivery The modes of delivery involve trained traditional Chinese medicine practitioners providing interventions face-to-face and individually. The type(s) of location(s) where the intervention occurred The entire treatment course, lasting approximately 10 minutes per session, was conducted in a dedicated treatment room affiliated with the Department of Traditional Chinese Medicine at Taichung Veterans General Hospital. The treatment protocol consisted of 8 sessions spanning 4 weeks. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Laser acupuncture device |
| Primary outcome measure | Changes in the number of monthly migraine days from baseline measured using a headache diary at each of the three follow-up time points (4th, 8th and 12th weeks) after randomization |
| Secondary outcome measures | The following secondary outcome measures were measured at each of the three follow-up time points (4th, 8th and 12th weeks): 1. The proportion of patients with a ≥ 30% reduction in migraine days measured using a headache diary 2. Changes in the following parameters: (1) headache duration measured using a headache diary; (2) headache severity measured using a Numerical Rating Scale (NRS) and (3) headache-related disability measured using the Migraine Disability Assessment Score (MIDAS) 3. Acute headache medications usage days per month measured using a headache diary |
| Overall study start date | 01/01/2022 |
| Overall study end date | 01/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 20 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Participant inclusion criteria | 1. Aged >20 years old and had CM managed pharmacologically, including preventive and/or acute migraine medications, and in addition, those who had refused preventive agents despite the recommendation of the neurologist 2. Unsatisfactory effect of current pharmacological treatments, defined by self-reporting 3. A minimum of a one-year history of migraine with or without aura |
| Participant exclusion criteria | 1. Received another LA therapy or traditional acupuncture at baseline 2. Migraine onset after the age of 50 3. Cognitive or psychological impairment interfering with the participant’s ability to receive LA protocol and describe symptoms 4. Patients with missing data at baseline or during the follow-up period |
| Recruitment start date | 01/04/2022 |
| Recruitment end date | 01/09/2023 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Taichung City
40705
Taiwan
Sponsor information
Hospital/treatment centre
Division of Neurology, Neurological Institute
No. 1650, Taiwan Boulevard, Sec. 4
Taichung City
40705
Taiwan
| Phone | +886 4 23592525 #3325 |
|---|---|
| bryanchouysvh@gmail.com | |
| Website | https://www.vghtc.gov.tw/ |
"ROR" |
https://ror.org/00e87hq62 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- 臺中榮民總醫院, TCVGH
- Location
- China
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to analyze the current data and draft a manuscript focusing on results with statistical differences. Subsequently, we intend to submit the manuscript for publication in academic journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request. The data collected from individual participants during the trial, once identified, will be accessible. This includes the Study Protocol, Statistical Analysis Plan, and Informed Consent Form. The data will be available immediately after publication and will have no set end date. Researchers interested in accessing the data can make requests by submitting a methodologically sound proposal aligned with the approved proposal's aims. The principal investigator, Wang Chi-Sheng, will maintain the data indefinitely. To submit proposals and gain access to the data, requestors should contact sam7227632@gmail.com. However, access will only be granted after signing a data access agreement, ensuring responsible and ethical use of the information. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 19/01/2024 | No | No | ||
| Statistical Analysis Plan | 19/01/2024 | No | No | ||
| Results article | 28/08/2024 | 02/09/2024 | Yes | No |
Additional files
Editorial Notes
02/09/2024: Publication reference added.
19/01/2024: Study's existence confirmed by the Institutional Review Board I &II of Taichung Veterans General Hospital.
