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Completed

NCT Number: NCT02373605

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
  • 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.
  • History of whiplash injury within the last 6 weeks
  • Diagnosis of cervical stenosis
  • Bilateral upper extremity symptoms
  • 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).
  • Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:
  • Muscle weakness involving a major muscle group of the upper extremity.
  • Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
  • Diminished or absent sensation to pinprick in any UE dermatome.
  • Prior surgery to neck of thoracic spine
  • Involvement in litigation or worker's compensation regarding their neck pain and/or headaches
  • PT or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam.
  • Any condition that might contraindicate spinal manipulative therapy.

Treatment and study plan

Dry Needling,Thrust Manipulation

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.

Other names: Spinal Manipulation, Dry Needling

Exercise,Non-thrust Mobilization

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. Change in Global Rating of Change Score

    Time frame: 1 week, 4 weeks, 3 months

  2. Change in Medication Intake (Frequency of medication intake in last week)

    Time frame: Baseline, 3 months

  3. 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

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2015
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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