Clinical Trials Logo

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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03453203
Study type Interventional
Source University Hospitals Cleveland Medical Center
Contact
Status Withdrawn
Phase N/A
Start date April 29, 2018
Completion date December 29, 2018

See also
  Status Clinical Trial Phase
Completed NCT05720819 - Biofeedback-VR for Treatment of Chronic Migraine N/A
Recruiting NCT05517200 - Pilot Study for a Machine Learning Test for Migraine
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Completed NCT02514148 - Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients N/A
Enrolling by invitation NCT02291380 - A Study to Evaluate Botulinum Toxin Type A for Injection(HengLi®)for Prophylactic Treatment of Chronic Migraine Phase 3
Completed NCT02122237 - Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial Phase 3
Withdrawn NCT02122744 - RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine N/A
Recruiting NCT02202486 - Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI N/A
Completed NCT01709708 - Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine Phase 4
Completed NCT01741246 - Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging N/A
Completed NCT01090050 - Treximet in the Treatment of Chronic Migraine Phase 4
Recruiting NCT03507400 - Introvision for Migraine and Headaches N/A
Completed NCT04161807 - Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine N/A
Completed NCT03175263 - OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain N/A
Withdrawn NCT04353505 - Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache Phase 1
Completed NCT01700387 - A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency Phase 4
Completed NCT01667250 - Non-Invasive Neurostimulation for the Prevention of Chronic Migraine N/A
Not yet recruiting NCT01135784 - Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache Phase 2
Completed NCT01496950 - Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine Phase 1
Completed NCT00772031 - NINDS CRC Chronic Migraine Treatment Trial Phase 3