Acupuncture is commonly used for the prevention of migraine and tension-type headaches, and has been found to be effective in reducing both the frequency and severity of these conditions. However, studies on acupuncture for medication overuse headache (MOH) are limited, and current research has not been able to determine whether its efficacy is due to the actual therapeutic effects of acupuncture or psychological benefits. To address this issue, the investigators have designed a clinical trial to evaluate the efficacy of acupuncture for MOH. In addition, the investigators will explore the regulatory effects of electroacupuncture on central mechanisms in MOH and conduct multi-omics analysis.
This is a multicenter, stratified, randomized, sham-controlled clinical trial. 120 eligible participants will be randomly allocated into electroacupuncture (EA), sham electroacupuncture (SEA), in a 1:1 ratio, which was divided into two phases Phase 1 : 1\. The EA group will receive 30 electroacupuncture treatments over an 12-week period, while the SEA group will receive sham electroacupuncture treatments with non-penetrating needling. The two control groups are matched to the MOH patient group by gender and age for recruitment when the planned MOH patient enrollment was nearly 80% complete, and 20 patients in each group will be included, for a total of 40 patients. Health education will be provided to participants in each group. The primary outcomes will be the changes of headache days per month from baseline after 12 weeks of treatment; The secondary outcomes will be as follows: The change from baseline in the number of headache days per month was also evaluated after 4 weeks of treatment, 8 weeks of treatment, 24 weeks of follow-up, and 36 weeks of follow-up; The proportion of responders, Headache Days per month, average daily headache time, headache Severity, average daily moderate-to-severe headache days, average daily moderate-to-severe headache time, Days with acute medication, Doses taken monthly, Severity of Dependence Scale, Headache Impact Test, EQOL-5D-5L, Hospital Anxiety and Depression Scale, Patients'expectation of the acupuncture efficacy, The Patient Global Impression of Change, The patient blinding assessment, Brain MRI Data Analysis and Multi-omics Analysis; The central randomization and data collection will be conducted by an electronic data management system. Phase 2: participants who adhere to the study protocol and complete the Week 36 follow-up will be considered to have completed the study. If the results of the first-phase trial demonstrate that electroacupuncture is superior to the control group, and the participants' willingness is confirmed, those willing to proceed will undergo the second-phase follow-up. The second phase of follow-up was conducted at 1, 2, and 3 years after the end of treatment.These included whether the participant was lost to follow-up, headache diary (including headache frequency and medication use), recurrence of MOH, new comorbidities, and assessments using SDS, HIT-6, HADS, PGIC, and EQ-5D-5L.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
The supine position, the local skin of the acupoints was routinely sterilized, and the selected acupoints were pasted with Acupuncture auxiliary device. The main acupuncture points are DU20, bilateral EX-HN5, ST8, GB20, GB20, LI4, LR3, ST40. Select compatible acupoints based on the patient's accompanying symptoms: 1.Discomfort in the neck: EX-B2 of Cervical 3-4; 2.Emotional anxiety, depression or sleep disorders: GV29, HT7; 3.Stomach or abdominal discomfort: CV12, ST25 and CV6. The disposable acupuncture needles and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China.The specifications of acupuncture needles are Φ0.30×25mm, Φ0.30×40mm, Φ0.30×50mm. The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.
The SEA group will use Hua Tuo brand disposable non-insertive sham control needles (Φ0.3mm×40mm) and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China. Sham points 1-2, 3-4, 5-6, and 7-8 are bilaterally located at the midpoints between the following pairs of acupoints: SP19 and EX-UE12, SP6 and LR5, EX-UE1 and HT1, and HT7 and SI8. sham LI4: Bilateral of midpoint between acupoint LI4 and LU9; sham LR3: Bilateral of midpoint between acupoint LR3 and ST44; sham ST40: Bilateral of midpoint between acupoint ST40 and GB35. Compatible acupoints: EX-B2 of Cervical 3-4 horizontal side by 0.5 cun; sham GV29: midpoint between acupoint GV29 and BL2. sham CV12: midpoint between acupoint CV12 and ST21; sham ST25: Bilateral of midpoint between acupoint ST25 and SP15; sham CV6: 3 cun lateral to the level of the CV6; The width of the interphalangeal joint of the patient's thumb was 1 "cun".
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang´anmen Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange in the number of headache days
Change from baseline in headache days per month
Time frame: At the end of week 12 after randomization.
Change in the number of headache days
Change from baseline in headache days per month
Time frame: At the end of week 4, week 8 after randomization; at week 24, week 36 of the follow-up period,
The proportion of responders
The proportion of patients with at least a 50% reduction from baseline in headache days per month and no overuse of acute pain medications
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in headache days per month
The proportion of patients with at least 50% reduction in headache days per month from baseline
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in mean daily headache duration
The changes from baseline in mean daily headache duration
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in mean daily headache duration
The proportion of patients with at least 50% reduction in mean daily headache duration from baseline
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in headache severity score per month
The changes from baseline in headache severity score per month. Headache severity is recorded daily on a 0-3 scale: 0 = No pain, 1 = Mild pain (does not interfere with activities), 2 = Moderate pain (interferes with some but not all activities), 3 = Severe pain (stops all activities) The monthly headache severity is calculated as the sum of the highest daily headache severity for each day in that month.
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in headache severity score per month
The proportion of patients with at least 50% reduction in headache severity score per month from baseline. Headache severity is recorded daily on a 0-3 scale: 0 = No pain, 1 = Mild pain (does not interfere with activities), 2 = Moderate pain (interferes with some but not all activities), 3 = Severe pain (stops all activities) The monthly headache severity is calculated as the sum of the highest daily headache severity for each day in that month.
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in the number of moderate and severe headache days per month
The changes from baseline in the number of moderate and severe headache days per month
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in the number of moderate and severe headache days per month
The proportion of patients with at least 50% reduction in the number of moderate and severe headache days per month
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in mean daily duration of moderate and severe headache
The changes from baseline in mean daily duration of moderate and severe headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in mean daily duration of moderate and severe headache
The proportion of patients with at least 50% reduction in mean daily duration of moderate and severe headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in number of days per month with acute medication for headache
The changes from baseline in number of days per month with acute medication for headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in number of days per month with acute medication for headache
The proportion of patients with at least 50% reduction in number of days per month with acute medication for headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in total number of doses taken per month for headache
The changes from baseline in total number of doses taken per month for headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
The proportion of patients with at least 50% reduction in total number of doses taken per month for headache
The proportion of patients with at least 50% reduction in total number of doses taken per month for headache
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Severity of Dependence Scale (SDS)
The changes from baseline in the scores of Severity of Dependence Scale (SDS). The original SDS consists of five items, each scored on a scale from 0 to 3. A score of 0 indicates "never or almost never," whereas a score of 3 indicates "always or almost always." The psychological dependence score is based on the first four items of the SDS, with a maximum possible score of 12, higher scores indicate a greater level of dependence. The fifth item concerns the treatment process and is not related to the baseline.
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Hospital Anxiety and Depression Scale (HADS)
The changes from baseline in the scores of Hospital Anxiety and Depression Scale (HADS). The HADS is used to assess anxiety and depression symptoms experienced over the past week. It consists of 14 items divided into two subscales (7 items each for anxiety and depression), with each item scored from 0 (no symptom) to 3 (severe symptom). Each subscale has a maximum score of 21, and higher scores indicate more severe symptoms. A score of ≥8 is defined as the presence of depression or anxiety.
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Headache Impact Test (HIT-6)
The changes from baseline in the scores of Headache Impact Test (HIT-6). The HIT-6 is a brief tool for assessing the impact of headaches in clinical research and practice. It covers multiple domains of health-related quality of life, including pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. Each of the six items is rated on a 5-point Likert scale (6 = Never, 8 = Rarely, 10 = Sometimes, 11 = Very Often, 13 = Always). The total HIT-6 score is the sum of these six item scores and ranges from 36 to 78. Higher scores indicate a greater impact of headaches.
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in Patient Global Impression of Change (PGIC)
The changes in the scores of The Patient Global Impression of Change (PGIC). The PGIC is used to assess the participant's subjective evaluation of overall improvement. The scale consists of seven levels:1 = Very much improved, 2 = Much improved, 3 = Somewhat improved, 4 = No change, 5 = Somewhat worse 6 = Much worse, 7 = Very much worse. Lower scores indicate greater improvement.
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Change in five-level version of EQ-5D (EQOL-5D-5L)
The changes from baseline in the five-level version of EQ-5D (EQOL-5D-5L). The EQ-5D-5L comprises two parts: 1.EQ-5D Descriptive System: This system measures health status across five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Each dimension has five levels, rated from 1 to 5: 1 = No problems/difficulty/discomfort, 2 = Slight problems/difficulty/discomfort 3 = Moderate problems/difficulty/discomfort, 4 = Severe problems/difficulty/discomfort, 5 = Extreme problems/difficulty/discomfort 2.EQ-5D Visual Analog Scale (VAS): This is a 20 cm vertical scale ranging from 0 to 100: 0 represents the "worst imaginable health", 100 represents the "best imaginable health". Higher scores on the VAS indicate better overall health status. This study uses the validated Chinese version of the EQ-5D-5L, which has demonstrated good reliability and validity.
Time frame: At the end of week 4, week 8 and week 12 after randomization; at week 24, week 36 of the follow-up period,
Patients'expectation of the acupuncture efficacy
Participants are asked, "Do you think your medication overuse headache (MOH) improved after completing acupuncture treatment?" They select one of the following five responses: 1.Significantly improved, 2.Very much improved, 3.Some improvement, 4.No improvement at all, 5.Unclear. Lower-number responses (1 or 2) reflect greater perceived improvement compared with higher-number responses.
Time frame: At baseline
The patient blinding assessment
participants are informed that there are two acupuncture therapies: conventional electroacupuncture and micro-electroacupuncture. Both therapies are effective, and in both cases, participants may or may not feel electrical stimulation. They are then asked whether they would accept conventional electroacupuncture. The answer options are: Difficult to distinguish Yes No
Time frame: Within 5 minutes after the completion of any week 12 treatment session
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