Treatment of Cervical Pain in Chronic Migraine

NCT03453203 | Withdrawn DMC

• 1 other identifier: UHClevelandMC1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Migraine

Keywords

Chronic migraine; Osteopathic manipulative treatment; Cervicalgia

Outcome Measures

Primary Outcomes (1)

• Treatment of Cervical Pain in Chronic Migraine

  Frequency of migraine days after treatment with Osteopathic manipulative treatment using counterstrain

  3 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Both arms with be diagnosed using tenderpoints In the control arm the tenderpoint will Be palpated for 90 secs with no counterstrain treatment applied. Both treatment and control groups will remain on their current migraine medication regiment.

Other: Osteopathic Manipulative Treatment Using Counterstrain

Treatment (conterstrain)

OTHER

Both arms with be diagnosed using tenderpoints. Treatment arm will be treated with counterstrain technique. 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 (a decrease in muscle tension). Both treatment and control groups will remain on their current migraine medication regiment.

Other: Osteopathic Manipulative Treatment Using Counterstrain

Interventions

Osteopathic Manipulative Treatment Using Counterstrain OTHER

Described in arm/group descriptions

Also known as: Strain/Counterstrain

Control; Treatment (conterstrain)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years of age who fit the ICHD-3 criteria for Chronic Migraine. These patients must be currently on an abortive agent (such as a triptans, NSAIDs) and require at least 8 doses a month.

You may not qualify if:

• Patients will be excluded if there are any signs of secondary headaches. If they have received BOTOX therapy in the past 4 months or are currently receiving BOTOX therapy. If the patients have contraindications to counterstrain OMT (clinical signs of Fractures, ligament instability, severe vertebral artery disease) or are a poor candidate for OMT (unable to follow commands, unable to fully relax).

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The follow-up physician will be blinded to treatment vs control arm. Patient will be selected randomly depending on the time of recruitment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded control trial

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 5, 2018
• Study Start: April 29, 2018
• Primary Completion: December 29, 2018
• Study Completion: December 29, 2018
• Last Updated: May 5, 2022

Record last verified: 2022-04