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Osteopathic manipulative therapy for Migraine (SMART-CM Trial)

N/A

Waitlist Available

Led By Robert P Lennon, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-intervention, week 36

Awards & highlights

SMART-CM Trial Summary

This trial will test if a specific osteopathic manipulative therapy can help treat chronic migraines. It will also see if patients are willing to try this therapy and if it shows any effectiveness.

Eligible Conditions

Migraine

SMART-CM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-intervention, week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-intervention, week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-intervention, week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recruitment metrics

Treatment satisfaction, first treatment

Treatment satisfaction, second treatment

Secondary outcome measures

Headache Diary

Headache impact test (HIT-6)

Healthcare Utilization

+3 more

SMART-CM Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Participants will receive 5 standardized osteopathic manipulative treatments, two weeks apart. (To be considered a study completer, a participant must complete at least 3 of these treatments.) In addition to assessments at intake and during treatments, 1 and 3 months after their last treatment patients will be asked to provide follow-up data. Assessments include the HIT-6, MIDAS, and MSQ surveys, treatment satisfaction assessments, and a headache diary. Participants will also consent to an electronic medical record extraction of medication and healthcare services utilization.

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Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,811 Total Patients Enrolled

Robert P Lennon, MDPrincipal InvestigatorPenn State Health Milton S Hershey Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this research encompass individuals younger than 60 years old?

"This trial is limited to those aged 18-60. For individuals younger than that, there are 43 trials available and for seniors, 178 studies can be accessed."

Answered by AI

Is this research recruiting participants at the moment?

"According to clinicaltrials.gov, this medical study is not currently seeking patients after being posted on September 8th 2022 and last updated the same day. However, there are 262 other trials that are still actively searching for participants."

Answered by AI

Am I eligible to partake in this medical trial?

"Qualifications to be admitted in this trial necessitate suffering from chronic migraine and being between the age of 18 and 60 years. A total of 40 patients will ultimately become partakers in this clinical study."

Answered by AI

What is the ultimate objective of this experiment?

"The primary measurement of the trial's success will be recruitment metrics, to be assessed over a 5 week time span. Secondary endpoints include quantification of headache morbidity through Headache Impact Test-6 (HIT-6), Migraine Specific Quality Of Life Questionnaire Version 2.1 (MSQ) and patient self-assessment in the form of headaches diaries."

Answered by AI

Recent research and studies

Therapeutic Advances in Neurological DisordersJournal

Onabotulinumtoxina in the Treatment of Patients with Chronic Migraine: Clinical Evidence and Experience

Chiang, Chia-Chun, and Amaal J. Starling. 2017. “Onabotulinumtoxina in the Treatment of Patients with Chronic Migraine: Clinical Evidence and Experience”. Therapeutic Advances in Neurological Disorders. SAGE Publications. doi:10.1177/1756285617731521.

The American Journal of MedicineJournal

Risks Associated with Spinal Manipulation

Stevinson, Clare, and Edzard Ernst. 2002. “Risks Associated with Spinal Manipulation”. The American Journal of Medicine. Elsevier BV. doi:10.1016/s0002-9343(02)01068-9.

Headache: The Journal of Head and Face PainJournal

Health Behaviors and Social Determinants of Migraine in a Canadian Population‐based Sample of Adults Aged 45‐85 Years: Findings from the CLSA

Hammond, Nicole G., and Arne Stinchcombe. 2019. “Health Behaviors and Social Determinants of Migraine in a Canadian Population‐based Sample of Adults Aged 45‐85 Years: Findings from the CLSA”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.13610.

Headache: The Journal of Head and Face PainJournal