Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03453203 |
| Other study ID # |
UHClevelandMC1 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 29, 2018 |
| Est. completion date |
December 29, 2018 |
Study information
| Verified date |
April 2022 |
| Source |
University Hospitals Cleveland Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chronic migraine (CM) is defined as a headache that occurs more than 15 days per month, which
has the features of migraine headache on at least 8 days per month.1 The cause of CM is not
well understood. Many patients with CM appear to have associated musculoskeletal neck pain.
The purpose of this study is to treat cervicalgia in patients with migraine and to look for
improvement in migraine frequency and intensity. Osteopathic manipulative treatment (OMT) can
diagnose and treat common musculoskeletal dysfunction. This may break facilitation within the
nervous system and reduce musculoskeletal pain which subsequently will reduce headache
frequency. This will be a randomized controlled trail comparing patients with CM treated with
OMT vs no treatment. The investigators will look at the frequency of migraine days before and
after the treatment period to determine migraine frequency and improvement.
Description:
Data will be analyzed by reviewing the amount of headache days during the treatment period
Patients will be distributed randomly into either the treatment arm or control arm. Subjects
will be randomized as they are recruited for the study (i.e. subject 1 treatment, subject 2
control, subject 3 treatment, etc.) The participants will be distributed by a research
assistant who will allocate the patients randomly to one of the two arms.
Both arms will be diagnosed using tenderpoints (Tenderpoints are small tense edematous areas
of tenderness about the size of a fingertip. They are typically located near bony attachments
of tendons, ligaments, or in the belly of some muscles).Tenderpoints will be documented and
stored in a secure flash drive.
Treatment arm will be treated with an Osteopathic manipulative treatment called counterstrain
technique. Osteopathic manipulative treatment is a hands on palpation of the tissues to
diagnose and treat neuromusculoskeletal dysfunction. Counterstrain is a passive manipulative
technique which the tissue being treated is positioned at a point of balance, or ease, AWAY
from the restrictive barrier (The most thought of form of manipulative technique is high
velocity low amplitude which is typically performed by chiropractors in spinal manipulation
which goes TOWARD the restrictive barrier and actually pass through the restrictive barrier).
Once a tenderpoint is found in the muscles the area of treatment is placed in a (three
dimensional) position that will eliminate the sensation (tenderness).The treatment position
is held for 90 seconds or until a release is felt (release is usually a decrease in the tone
or muscle tension).
In the control arm the tenderpoint will Be palpated for 90 seconds with no counterstrain
treatment applied. (Risk are possible soreness at palpation site though not likely, there is
no benefit) Both treatment and control groups will remain on their current migraine
medication regiment.
They will follow-up with Dr. Deborah Reed, MD, FAHS who is a board certified neurologist and
headache specialist. This investigator will be blinded to weather the patient received
counterstrain manipulation or no treatment. The investigator will document the number of
headache days between follow-up periods.
After the first treatment follow-up will occur as follows: Week 1, Week 2, Week 4, Week 6,
Week 10. This is picked somewhat arbitrarily as typical treatment follow-ups will vary from
patient to patient depending on the severity of the musculoskeletal dysfunction (somatic
dysfunction).
