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

June 4, 2018 updated by: James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture

Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache: a Multi-center Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36117
        • Alabama Physical Therapy & Acupuncture

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry Needling,Thrust Manipulation
Other: 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.
Other Names:
  • Spinal Manipulation
  • Dry Needling
Active Comparator: Exercise,Non-thrust Mobilization
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.
Other Names:
  • Exercise
  • Non-thrust Mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Headache Intensity (NPRS) (Rating Score)
Time Frame: Baseline, 1 week, 4 weeks, 3 months
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Baseline, 1 week, 4 weeks, 3 months
Change in Headache Frequency (Number of headaches in the last week)
Time Frame: Baseline, 1 week, 4 weeks, 3 months
Number of headaches in the last week
Baseline, 1 week, 4 weeks, 3 months
Change in Disability (NDI 0-50 points)
Time Frame: Baseline, 1 week, 4 weeks, 3 months
10 Questions each worth 0-5 points with maximum score of 50 points possible. Baseline score must exceed 10/50 to be included in study.
Baseline, 1 week, 4 weeks, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Global Rating of Change Score
Time Frame: 1 week, 4 weeks, 3 months
1 week, 4 weeks, 3 months
Change in Medication Intake (Frequency of medication intake in last week)
Time Frame: Baseline, 3 months
Baseline, 3 months
Change in Headache Duration (Total hours of headaches in the last week)
Time Frame: Baseline, 1 week, 4 weeks, 3 months
Total hours of headaches in the last week
Baseline, 1 week, 4 weeks, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alabama Physical Therapy & Acupuncture

Collaborators

Universidad Rey Juan Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 15, 2018

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAMT0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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