Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT03453203
Status:
WITHDRAWN
Last Update Posted:
2022-05-05
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Cervical Pain in Chronic Migraine
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
Treatment of Cervical Pain in Chronic Migraine
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: