Clinical trial NCT06546462: Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders?
Official title: Can a Specific OMT Protocol Influence Patient-reported Pain and Associated Analgesia Use for Primary Headache Disorders?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Headache Disorders
Headache
Analgesia
Opioid Use
Osteopathy
Keywords: Osteopathic manipulative medicine
Osteopathic manipulative treatment
Headache
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The purpose of this study is to evaluate the effectiveness of osteopathic manipulative treatment protocol (OMT) or light touch protocol in reducing headache frequency and the use of pain medication for headache pain. Previous research has suggested that OMT may alleviate headache symptoms. This randomized controlled trial aims to determine whether regular OMT sessions can decrease headache discomfort and reduce the use of pain medications, including over-the-counter medications, migraine-specific treatments, and opioids. The study consists of a ten-week period, including 2 weeks of observation, 6 weeks of intervention, and 2 weeks of washout. Participants will be randomly assigned to either receive OMT or a light touch protocol. Investigators will compare questionnaires assessing quality of life and functionality scales. Pain levels and medication use will be logged daily throughout the study.

Eligibility criteria: Inclusion Criteria:

* 18 to 75 years of age
* takes opioids or any other pain medication for headaches more than 10 times a month (including over the counter and prescription medications for headaches).
* 3 months or greater history of headaches or migraines
* Patient able to tolerate OMT based on osteopathic physician discretion and with consideration of absolute and relative contraindications to OMT

Exclusion Criteria:

* current diagnosis of neoplasm
* history of headache secondary to trauma or concussion
* history of brain/cranial surgery, cerebral vascular events/disease (e.g., stroke, Brain arteriovenous malformation (AVM), vertebral artery disease)
* acute psychiatric diagnosis
* pregnancy
* history of substance use disorder

Primary outcomes:
measure: Change in pain levels
timeFrame: Assessment of weekly average pain from week 1 till week 10 end of the study period
measure: Change in analgesia use
timeFrame: Assessment of weekly amount of pain medications used from week 1 till week 10 end of the study period
Secondary outcomes:
measure: Change in quality of Life - Headache disability index
timeFrame: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
measure: Change in quality of Life - Headache Impact Test (HIT-6)
timeFrame: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
measure: Change in quality of Life - The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group (EQ-5DL)
timeFrame: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: Riland Academic Health Care Center
state: New York
Study officials:
affiliation: New York Institute of Technology
name: Sheldon Yao, D.O
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jara Silva CE, Joseph AM, Khatib M, Knafo J, Karas M, Krupa K, Rivera B, Macia A, Madhu B, McMillan M, Burtch J, Quinonez J, Albert T, Khanna D. Osteopathic Manipulative Treatment and the Management of Headaches: A Scoping Review. Cureus. 2022 Aug 9;14(8):e27830. doi: 10.7759/cureus.27830. eCollection 2022 Aug.
citation: Chin J, Qiu W, Lomiguen CM, Volokitin M. Osteopathic Manipulative Treatment in Tension Headaches. Cureus. 2020 Dec 12;12(12):e12040. doi: 10.7759/cureus.12040.