Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders?
NCT Number: NCT06546462
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Headache Disorders|Headache|Analgesia|Opioid Use|Osteopathy
Interventions: OTHER: Osteopathic Manipulative Treatment (OMT)|OTHER: Sham Light touch arm
Sponsor: New York Institute of Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2025-12-31
Locations: Riland Academic Health Care Center, Old Westbury, New York, 11545, United States

Summary:
The purpose of this study is to see if osteopathic manipulation or light touch can reduce either or both frequency of headaches or use of pain medication. Osteopathic manipulative treatment (OMT) has been shown to help headache symptoms. The investigators like to see if regular OMT sessions can help reduce headache discomfort and also reduce use of pain medication like over-the-counter medications, migraine medications, and opioids. In this randomized controlled trial, a set sequence of OMT will be compared to light touch sham protocol. Investigators will compare participant responses to questionnaires that assess items including pain levels and reported pain medication use for the course of the study period to see if there are any shifts.

Primary Outcome Measures: Change in pain levels, The primary outcome measures will assess if consistent use of OMT for headache causes a reduction in headache pain for headache-associated discomfort. Pain will be rated on a Numeric Rating Scale (NRS) so individuals can rate their pain on a scale from 0 (no pain) to 10 (worst possible pain)., Assessment of weekly average pain from week 1 till week 10 end of the study period|Change in analgesia use, The primary outcome measures will assess if consistent use of OMT for headache causes a reduction in headache analgesia use for headache-associated discomfort., Assessment of weekly amount of pain medications used from week 1 till week 10 end of the study period
Secondary Outcome Measures: Change in quality of Life - Headache disability index, Secondary measures will assess any changes to physical and mental health and reduce the impact of headaches via the Headache disability index. Max score = 100. The higher the score the worse the symptoms. A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects., To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)|Change in quality of Life - Headache Impact Test (HIT-6), Secondary measures will assess any changes to physical and mental health and reduce the impact of headaches via the Headache Impact Test (HIT-6) Higher scores indicate a greater impact on your life. Score range 36-78., To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)|Change in quality of Life - The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group (EQ-5DL), Secondary measures will assess any changes to physical and mental health and reduce the impact of headaches via EQ-5DL - quality of life measure. 5 questions rated on levels with 5 being the highest level of disability and an additional questions on overall health rated on a scale of 100 with 100 being the best possible health and 0 being being the worst possible health., To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)