Chiropractic Care for Episodic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Recruitment feasibility (average number of participants per month)
研究概览
简要总结
Migraine, a chronic intermittent headache disorder, ranks in the top five causes of years lived with disability. One promising non-pharmacologic and integrative treatment for migraine may be chiropractic care due to the co-occurrence of migraine and musculoskeletal complaints. The goal of this application is to perform a pilot study of chiropractic care for episodic migraine to help inform the design of a future, full-scale pragmatic effectiveness trial.
详细描述
Migraine, a chronic intermittent headache disorder, ranks in the top five causes for years lived with disability. Due to the high disability burden associated with migraine, individuals who experience migraine often seek treatments to reduce the frequency and severity of their attacks and often express interest in nonpharmacologic and integrative approaches. One promising treatment may be chiropractic care due to the comorbidity of migraine and musculoskeletal complaints.
Our long-term goal is to conduct a multi-site large-scale, fully powered trial evaluating the effectiveness of a validated multimodal chiropractic care intervention to reduce migraine frequency, severity, and disability.
To help inform the design of a large-scale trial with both pragmatic and explanatory features, we propose to conduct a two-arm pilot randomized attention-controlled trial at two sites which are representative of sites to be included in the future large-scale trial. We will recruit and randomize 60 individuals (30 per site) to either 1) 14 visits of chiropractic care (CC) (6 visits of CC over 3-5 weeks followed by 8 visits of CC over 12 weeks); or 2) 14 sessions of headache health education (15-minute 1:1 virtual sessions focused on pre-defined migraine specific topics) - both added to usual medical care. This study will allow us to address the following aims: 1) To train a team of chiropractors from established clinics within two academic medical centers with existing partnerships with headache programs, refine our intervention, and assess the fidelity of intervention protocols; 2) To optimize data collection, data management, and reporting procedures across sites and establish the infrastructure needed for a large-scale trial; 3) To assess the feasibility of recruitment, retention, and adherence across multiple study sites; 4) To assess participant expectations and treatment experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
While participants, treating chiropractors, study coordinators, and research assistants will be unblinded to treatment assignment, study investigators who are not involved in providing chiropractic care treatments or monitoring adverse events will be blinded. The blinding of these investigators and the programmer will only be broken after approval of the final statistical analysis plan and locking of the trial data.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Confirmed diagnosis of migraine with or without aura which does not meet criteria for chronic migraine according to the International Classification for -Headache Disorders (ICHD)-3 guidelines at the screening visit with the study physician
- •History of migraines dating for at least one year
- •Completion of at least 26 headache diary days out of 28
- •Confirmed migraine frequency ≥4 to ≤13 days per month during a run-in period
- •If use of medication is applicable, dose must be stable for 2 months prior to study enrollment
- •If use of medication for non-migraine pain condition is applicable (with the exception of episodic tension type headache), dose must be stable for 2 months prior to study enrollment
- •Willing and able to complete all study procedures and be randomized to either of the two intervention groups
- •Fluency in English
- •Confirmed access to and proficiency with use of a smartphone, computer, and/or tablet
- •Working email address or willingness to create an email account for the study
排除标准
- •Non-Veterans (VAMC only)
- •Received botulinum toxin treatment for headache and/or neck pain within the 4 months prior to the start of the baseline phase
- •Received chiropractic care for any condition within the 3 months prior to the start of the baseline phase
- •Received behavioral interventions (e.g., cognitive behavioral therapy, acceptance and commitment therapy, mindfulness, relaxation techniques, hypnosis) within the past 3 months)
- •Used neuromodulation (i.e., "headache devices"), procedures for migraine prevention within the 2 months before the baseline period, or investigational medications or headache devices for at least 90 days prior to screening
- •Diagnosis of medication overuse headache according to the ICHD-3 guidelines at the screening visit with the study physician
- •Traumatic Brain Injury ≤ 1 year before screening visit or worsening of migraine as noted by the screening study physician
- •Head or neck trauma within the past year causing neurological or musculoskeletal signs or symptoms requiring treatment
- •Any medical, neurologic, or psychiatric condition that the screening study physician deems would lead to difficulty complying with the protocol or negatively impact the safety profile of the interventions
- •Psychiatric hospitalization in the last 6 months
- •Receiving hospice or palliative care
- •History of carotid or vertebral artery dissection
- •Presence of carotid bruits
- •Presence of contraindications (relative or absolute) for spinal manipulation or mobilization where these procedures cannot be modified for safe administration and are consistent with those published by the World Health Organization (WHO) guidelines, including but not limited to:
- •Local spinal hypermobility/instability
- •Conditions causing general spinal hypermobility, such as Marfan, Ehlers-Danlos syndrome, and Osteogenesis imperfecta
- •Malignancy of the spine or spinal cord
- •Frank disc herniation with signs of progressive neurological deficit
- •Spinal or intracanalicular hematomas Inflammatory spondyloarthropathies such as rheumatoid arthritis
- •Spinal fractures or dislocations
- •Avascular necrosis in an area of proposed joint manipulation
- •Bone-weakening disorders affecting the spine, such as benign bone tumors, infection, or osteoporosis
- •Vertebrobasilar insufficiency syndrome
- •Aneurysm involving a major blood vessel in an area of potential joint manipulation
- •History of stroke
- •Anticoagulant therapy or blood disorders cause significant bleeding tendency
- •Cervical spine congenital anomalies that affect the stability or neurologic integrity of the individual or history of cervical spine surgery
- •Either self-reported current alcohol or substance use disorder or current alcohol or substance use disorder documented by a treating medical provider within the past 6 months
- •Hormone replacement therapy for less than six months, or if prescriptions greater than 6 months in duration must be at a stable dose
- •Significant cognitive impairment that would impair participation in the trial
- •Currently pregnant or intention to become pregnant within the next six months
研究组 & 干预措施
Chiropractic Care
4 sessions of chiropractic care (6 sessions of chiropractic care over 3-5 weeks followed by 8 sessions of chiropractic care over 12 weeks); participants will be allowed to continue usual care throughout the study.
干预措施: Chiropractic Care (Procedure)
Headache Health Education (HHE)
Participants randomized to Headache Health Education (HHE) will receive 14 interactive 15-minute education sessions delivered via videoconference.
干预措施: Headache Health Education (Behavioral)
结局指标
主要结局
Recruitment feasibility (average number of participants per month)
时间窗: 16 months
Each site will be able to recruit 30 participants within 16 months
Retention feasibility (proportion of participants not lost to follow-up)
时间窗: 20 weeks
Retention will be quantified by the proportion of subjects who record their migraines for at least 26 out of 28 days and all questionnaires at each outcome assessment.
Intervention adherence feasibility
时间窗: 15 weeks
Adherence will be calculated as the proportion of subjects who attend at least 80% of the chiropractic care visits or 80% of the one-on-one headache health education video-conferences.
Recruitment feasibility (average number of participants per month)
时间窗: 16 months
Each site will be able to recruit 30 participants within 16 months
Retention feasibility (proportion of participants not lost to follow-up)
时间窗: 20 weeks
Retention will be quantified by the proportion of subjects who record their migraines for at least 26 out of 28 days and all questionnaires at each outcome assessment.
次要结局
- Number of days with migraine headaches(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Proportion of responders(Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks).)
- Average severity of migraine attacks(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Average number of hours for a migraine attack (duration)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Average number of medications used for a migraine attack(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Neck Disability Index (NDI)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Headache Related Disability (HIT-6)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- PTSD Checklist for DSM-5 (PCL-5)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Godin Leisure-Time Exercise Questionnaire (GLTEQ)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- The Expectations for Complementary and Alternative Medicine Treatments Questionnaire short form (EXPECT)(Assess only at baseline following the 4 weeks run-in phase but before randomization.)
- Average severity of migraine attacks(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Average number of hours for a migraine attack (duration)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Average number of medications used for a migraine attack(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Neck Disability Index (NDI)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Headache Related Disability (HIT-6)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- PTSD Checklist for DSM-5 (PCL-5)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Godin Leisure-Time Exercise Questionnaire (GLTEQ)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- The Expectations for Complementary and Alternative Medicine Treatments Questionnaire short form (EXPECT)(Assess only at baseline following the 4 weeks run-in phase but before randomization.)
研究者
Peter M. Wayne, Ph.D.
Associate Professor of Medicine
Brigham and Women's Hospital