Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache

NCT ID: NCT02373605

Last Updated: 2018-06-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-05-15

Brief Summary

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The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. This study is attempting to find out if one treatment strategy is more effective than the other.

Detailed Description

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Patients with cervicogenic headaches will be randomized to receive 1-2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) Dry Needling and HVLA thrust manipulation group, or the (2) Exercise and non-thrust mobilization group

Conditions

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Cervicogenic Headaches

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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Dry Needling,Thrust Manipulation

Group Type EXPERIMENTAL

Dry Needling,Thrust Manipulation

Intervention Type OTHER

HVLA thrust manipulation to upper cervical and upper thoracic regions. Dry needling to cervicothoracic and craniofacial regions. Up to 8 treatment sessions over 4 weeks.

Exercise,Non-thrust Mobilization

Group Type ACTIVE_COMPARATOR

Exercise,Non-thrust Mobilization

Intervention Type OTHER

Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.

Interventions

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Dry Needling,Thrust Manipulation

HVLA thrust manipulation to upper cervical and upper thoracic regions. Dry needling to cervicothoracic and craniofacial regions. Up to 8 treatment sessions over 4 weeks.

Intervention Type OTHER

Exercise,Non-thrust Mobilization

Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.

Intervention Type OTHER

Other Intervention Names

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Spinal Manipulation Dry Needling Exercise Non-thrust Mobilization

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
2. Headache frequency of at least one per week for a minimum of 3 months
3. Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50

Exclusion Criteria

1. Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
2. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc.
3. History of whiplash injury within the last 6 weeks
4. Diagnosis of cervical stenosis
5. Bilateral upper extremity symptoms
6. Evidence of CNS involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).
7. Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:

1. Muscle weakness involving a major muscle group of the upper extremity.
2. Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
3. Diminished or absent sensation to pinprick in any UE dermatome.
8. Prior surgery to neck of thoracic spine
9. Involvement in litigation or worker's compensation regarding their neck pain and/or headaches
10. PT or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam.
11. Any condition that might contraindicate spinal manipulative therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role collaborator

Alabama Physical Therapy & Acupuncture

OTHER

Sponsor Role lead

Responsible Party

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James Dunning, DPT, MSc, FAAOMPT

DPT MSc FAAOMPT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Dunning, DPT PhD

Role: PRINCIPAL_INVESTIGATOR

American Academy of Manipulative Therapy

Locations

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Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, United States

Site Status

Countries

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United States

References

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Dunning J, Butts R, Zacharko N, Fandry K, Young I, Wheeler K, Day J, Fernandez-de-Las-Penas C. Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multicenter randomized clinical trial. Spine J. 2021 Feb;21(2):284-295. doi: 10.1016/j.spinee.2020.10.008. Epub 2020 Oct 13.

Reference Type DERIVED
PMID: 33065273 (View on PubMed)

Other Identifiers

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AAMT0001

Identifier Type: -

Identifier Source: org_study_id

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