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Cervical-Cranial Dry Needling vs. Orthopedic Manual Therapy for Cervicogenic Headache

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ClinicalTrials.gov Identifier: NCT03583190
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
Franklin Pierce University
Information provided by (Responsible Party):
Youngstown State University

Brief Summary:
Dry needling is a therapeutic modality used to treat a number of neuromusculoskeletal conditions. Practice trends suggest it is becoming widely used by Physical Therapists to help patients manage symptoms associated with CGH, however, there is limited scientific evidence demonstrating meaningful impact for dry needling for CGH. Manual therapy (thrust and non-thrust mobilizations) to the cervical spine are well researched and have an established treatment effect for managing symptoms related to CGH. The purpose of this study is to compare outcomes (1 week, 1 month, 3 months, 12 months) for patients with CGH treated with cervical-cranial dry needling or pragmatically applied orthopedic manual therapy to the cervical spine. In addition to either the cervical-cranial dry needling or manual therapy to the cervical spine, patients will also receive patient education, thoracic manipulation, and exercise.

Condition or disease Intervention/treatment Phase
Cervicogenic Headache Other: Cervical-cranial dry needling Other: Orthopedic manual therapy Other: Thoracic Manipulation Other: Exercise Other: Patient Education Not Applicable

Detailed Description:

The use of dry needling is becoming widely used by Physical Therapists in the United States for a number of neuromusculoskeletal conditions including cervicogenic headache (CGH). Dry needling is performed by taking a mono-filament needle and inserting it into symptomatic soft tissue. In this trial, the dry needling will be performed segmentally in the neck and along the patient's headache distribution pattern. Orthopedic manual therapy (OMT) may include both thrust and non-thrust techniques applied to a targeted spinal level and has a well-established treatment effect for patients with CGH. In this trial, the OMT will be applied pragmatically to the cervical spine at the most symptomatic level of the headache. Other interventions used in this trial will include patient education, thoracic manipulation and exercise.

Patients will be randomized to receive either dry needling or OMT 2x/week for 2 weeks and then 1-2x/week for 2 weeks totaling 6-8 visits over the course of 1 month. The 1 week and 1 month outcomes collected will be reported on separately from the 3 and 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: The outcome assessor will be blinded the treatment group. The clinician providing treatment will be blinded to outcomes.
Primary Purpose: Treatment
Official Title: Comparing the Use of Cervical-Cranial Dry Needling With Orthopedic Manual Therapy to the Cervical Spine for Cervicogenic Headache: A Multi-center RCT With 1-Year Follow Up
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : June 10, 2022
Estimated Study Completion Date : June 10, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cervical-cranial dry needling
Patients randomized to this arm will receive cervical-cranial dry needling, thoracic manipulation, and exercise.
Other: Cervical-cranial dry needling
Segmental needling of the neck and needling in the patient's headache distribution. Peripherally sensitized areas of the neck may also be dry needled based on the findings of the clinical evaluation.

Other: Thoracic Manipulation
Thoracic Manipulation (applied pragmatically) to the levels determined to be provocative or hypomobile.

Other: Exercise
Clinicians select 1 active range of motion exercise for the cervical spine, deep cervical flexion endurance exercise, and 5 upper extremity exercises (from a set of 10). Additionally, patients will be assigned a headache management technique.

Other: Patient Education
Patients will receive education regarding their headache condition, proper performance of their symptom management technique, posture.

Active Comparator: Orthopedic Manual Therapy
Patients randomized to this arm will receive orthopedic manual therapy to cervical spine, thoracic manipulation, and exercise.
Other: Orthopedic manual therapy
Orthopedic Manual Therapy (OMT) that includes either mobilization or manipulation to the cervical spine applied pragmatically to the most symptomatic level.

Other: Thoracic Manipulation
Thoracic Manipulation (applied pragmatically) to the levels determined to be provocative or hypomobile.

Other: Exercise
Clinicians select 1 active range of motion exercise for the cervical spine, deep cervical flexion endurance exercise, and 5 upper extremity exercises (from a set of 10). Additionally, patients will be assigned a headache management technique.

Other: Patient Education
Patients will receive education regarding their headache condition, proper performance of their symptom management technique, posture.




Primary Outcome Measures :
  1. Change in NPRS headache intensity [ Time Frame: Baseline, 1 week, 1 month, 3 months, 12 months. ]
    Average and most intense in the last week will be recorded using a 0 (no headache) to 10 (most intense)


Secondary Outcome Measures :
  1. Change in disability using Neck Disability Index [ Time Frame: Baseline 1 week, 1 month, 3 months, 12 months ]
    The NDI is a self-report measure of perceived disability comprised of ten questions using an ordinal scale from 0 to 5 for a maximum of 50 points.

  2. Change in disability using Headache Disability Index (HDI) [ Time Frame: Baseline, 1 week, 1 month, 3 months, 12 months ]
    The HDI assesses "the burden of chronic headaches," using 25 items that ask about the perceived impact of headaches on emotional functioning and daily activities. Items were designed specifically to assess the concerns of individuals with recurrent headache disorders.

  3. Leeds Assessment of Neuropathic Signs and Symptoms (LANSS) [ Time Frame: Baseline ]
    Subjects identifying particular qualities about their pain (yes/no) that could suggest problems with how the nervous system is interpreting pain. There is a physical screening procedure involving a discriminate evaluation of different sensations (light touch, and sharp/dull) in an area of the subject's body (arm or leg) without pain compared to an area of their pain (neck or head). The questions and results from the physical testing are scored which can range from 0-24.

  4. Change in Medication intake [ Time Frame: Baseline, 1 week, 1 month, 3 months, 12 months ]
    Patients will identify the medications + dosage they have consumed to treat their headache in the past week.

  5. Patient Satisfaction [ Time Frame: 1 month ]
    Patient satisfaction will be assessed using the Patient Satisfaction Instrument (PSI) that measures several constructs related to clinical outcomes and patient care. The PSI consists of 12 questions rated using a scale, 1 (strongly disagree) to 5 (strongly agree).

  6. Health care utilization [ Time Frame: 3 and 12 months ]
    Healthcare utilization will be reported by subjects identifying on a form any provider they have seen for care of their headaches, treatments they have received, and cost for their headaches.

  7. SANE Percent Recovery [ Time Frame: 1 month ]
    Percent recovery will be measured using a global percentage of improvement is a measure of the patient's perception of the change in their condition.

  8. Change in current NPRS neck or headache intensity [ Time Frame: Baseline and Immediately post intervention ]
    Current level of headache or neck pain on a scale ranging from 0 (no headache) to 10 (most intense)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Meets the IHS criteria for CGH
  • Headache frequency of at least 1 per week over a period greater than 3 months.
  • Demonstrates segmental dysfunction with passive mobility testing.

Exclusion Criteria:

Patients whose headache experience is primarily of migraine origin. Tension-type headache, headache pain <2, contraindications to the interventions (malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use), headache presentation suggesting cervical arterial insufficiency, severe metal allergy, needle phobia, history of neck or thoracic spine surgery, Non-English speaking patients, therapist is unable to elicit the headache with passive accessory intervertebral movements (PAIVM), or pending litigation for neck pain and/or headache.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583190


Contacts
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Contact: David Griswold, PhD 330-941-2419 dwgriswold@ysu.edu

Locations
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United States, Ohio
Youngstown State University Recruiting
Youngstown, Ohio, United States, 44406
Contact: David W Griswold, PhD, DPT    330-941-2419    dwgriswold@ysu.edu   
Sponsors and Collaborators
Youngstown State University
Franklin Pierce University
Investigators
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Principal Investigator: David Griswold, PhD Associate Professor at Youngstown State University

Publications:
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Responsible Party: Youngstown State University
ClinicalTrials.gov Identifier: NCT03583190    
Other Study ID Numbers: 170-18
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Youngstown State University:
Neck pain
Headache
Dry needling
manual therapy
Additional relevant MeSH terms:
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Post-Traumatic Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases