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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNew York Institute of Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Osteopathic Manipulative Treatment (OMT)

    Other intervention

    The active arm will receive osteopathic manipulative treatment which is a hands-on treatment modality use to treat a variety of health concerns.

  • Sham Light touch arm

    Other intervention

    Sham arm will receive a light touch sham treatment.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Osteopathic Manipulation armExperimental treatment 1 intervention
Group B: Sham Light touch armSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Assessment of weekly average pain from week 1 till week 10 end of the study period
2

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.

Time frame
Assessment of weekly amount of pain medications used from week 1 till week 10 end of the study period

Secondary outcomes

1

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.

Time frame
To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
2

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.

Time frame
To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
3

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.

Time frame
To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)

Other outcomes

Sponsors and contacts

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