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Not yet recruiting NCT06546462

Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders?

No phase Interventional Headache Disorders Headache Analgesia Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Osteopathic Manipulative Treatment (OMT), Sham Light touch arm.
Who it may be relevant to
Registry conditions: Headache Disorders, Headache, Analgesia, Opioid Use. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Can a Specific OMT Protocol Influence Patient-reported Pain and Associated Analgesia Use for Primary Headache Disorders?

Overview

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.

Interventions

  • Other Osteopathic Manipulative Treatment (OMT)
    The active arm will receive osteopathic manipulative treatment which is a hands-on treatment modality use to treat a variety of health concerns.
  • Other Sham Light touch arm
    Sham arm will receive a light touch sham treatment.

Primary outcome measures

  • Change in pain levels [Time frame: Assessment of weekly average pain from week 1 till week 10 end of the study period]
  • Change in analgesia use [Time frame: Assessment of weekly amount of pain medications used from week 1 till week 10 end of the study period]
Secondary outcome measures (3)
  • Change in quality of Life - Headache disability index [Time frame: 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) [Time frame: 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) [Time frame: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Riland Academic Health Care Center — Old Westbury

Publications

  • 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. PMID 36110479
  • 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. PMID 33457139

Identifiers

NCT: NCT06546462 · Headache OMT · BHS-1852

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗