Chiropractic Spinal Manipulation for Headache

NCT ID: NCT05240547

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2024-12-14

Brief Summary

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This is a pilot and feasibility randomized controlled trial to assess the efficacy of chiropractic spinal manipulative therapy in patients with tension-type and cervicogenic headache.

Detailed Description

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This study is a pilot and feasibility randomized controlled trial that aims to assess the efficacy of 8 treatment sessions of chiropractic spinal manipulative therapy compared to the same number of sham manipulative therapy or placebo interventions for chronic cervicogenic and tension-type headache. The hypothesis proposed is that chiropractic care will reduce the intensity and frequency of both cervicogenic and tension-type headache episodes, when compared to placebo. A sample of 20 participants suffering from cervicogenic or tension-type headache for at least 3 months, aged 18 to 67 will be randomized to receive either 8 sessions of spinal manipulative treatment (2 times per week for a total of 4 weeks) or 8 sessions of a validated sham spinal manipulation. Outcomes will be assessed at baseline, after 4 treatments and at the end of the treatment period.

Conditions

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Cervicogenic Headache Tension-Type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Spinal manipulation

Spinal manipulative therapy will be delivered to the cervical spine (segments including occiput-atlas to C7-D1) according to the chiropractors' evaluation during each visit. During each session, one or two segments will be manipulated using a high-velocity low-amplitude thrust manipulation (a joint cavitation will be expected, if not, the thrust can repeated once) applied to the segments with the highest motion restriction, as determined by the chiropractor by static and motion palpation of the cervical spine.

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type OTHER

Spinal manipulative therapy delivered to the cervical spine by a chiropractor

Placebo

Sham manipulation will be delivered to the cervical spine (segments including occiput-atlas to C7-D1) according to the chiropractors' evaluation during each visit. During each session, one or two segments will receive a sham manipulation applied to the segments with the highest motion restriction, as determined by the chiropractor by static and motion palpation of the cervical spine. The sham manipulation will consist in a identical contact to the real manipulation, except the thrust will be delivered towards the table, away from the target segment and with the intention to lower the cervical drop piece of the table, which will substitute the joint cavitation noise.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Sham manipulative treatment delivered to the cervical spine by a chiropractor

Interventions

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Spinal Manipulation

Spinal manipulative therapy delivered to the cervical spine by a chiropractor

Intervention Type OTHER

Placebo

Sham manipulative treatment delivered to the cervical spine by a chiropractor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least 2 episodes per month of cervicogenic or tension-type headache for at least 3 months. Diagnoses will be determined by case history and physical examination according to the International Headache Society criteria (3rd Edition)

* Having received chiropractic treatment in the previous 12 months
* Diagnosis or frequent symptoms of migraine headaches (symptoms present at least once a month) without an overlapping presentation of cervicogenic or tension-type headache.
* Patients with pathologies affecting the nervous system (MS, tumors, past history of stroke...)
* Contraindications to manual therapy, particularly spinal manipulative therapy (cancer, uncontrolled high blood-pressure, severe cardiovascular conditions)
* Past history of cervical spine surgery
* Pregnancy
* Having being diagnosed with a psychiatric conditions, with the exception of depression and anxiety
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Real Centro Universitario Maria Cristina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Gevers Montoro, DC, MSc

Role: PRINCIPAL_INVESTIGATOR

RCU María Cristina

Locations

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Real Centro Universitario María Cristina

El Escorial, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Elisa Torres Gonzalez, BSc

Role: CONTACT

918909435

Facility Contacts

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Carlos Gevers-Montoro, DC,MSc

Role: primary

+34-918909435

Other Identifiers

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SMTHA

Identifier Type: -

Identifier Source: org_study_id

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