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

Primary Purpose

Cervicogenic Headache

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical-cranial dry needling
Orthopedic manual therapy
Thoracic Manipulation
Exercise
Patient Education
Sponsored by
Youngstown State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Neck pain, Headache, Dry needling, manual therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Youngstown State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cervical-cranial dry needling

Orthopedic Manual Therapy

Arm Description

Patients randomized to this arm will receive cervical-cranial dry needling, thoracic manipulation, and exercise.

Patients randomized to this arm will receive orthopedic manual therapy to cervical spine, thoracic manipulation, and exercise.

Outcomes

Primary Outcome Measures

Change in NPRS headache intensity
Average and most intense in the last week will be recorded using a 0 (no headache) to 10 (most intense)

Secondary Outcome Measures

Change in disability using Neck Disability Index
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.
Change in disability using Headache Disability Index (HDI)
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.
Leeds Assessment of Neuropathic Signs and Symptoms (LANSS)
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.
Change in Medication intake
Patients will identify the medications + dosage they have consumed to treat their headache in the past week.
Patient Satisfaction
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).
Health care utilization
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.
SANE Percent Recovery
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.
Change in current NPRS neck or headache intensity
Current level of headache or neck pain on a scale ranging from 0 (no headache) to 10 (most intense)

Full Information

First Posted
June 18, 2018
Last Updated
October 24, 2022
Sponsor
Youngstown State University
Collaborators
Franklin Pierce University
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1. Study Identification

Unique Protocol Identification Number
NCT03583190
Brief Title
Cervical-Cranial Dry Needling vs. Orthopedic Manual Therapy for Cervicogenic Headache
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
August 10, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Youngstown State University
Collaborators
Franklin Pierce University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Neck pain, Headache, Dry needling, manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
The outcome assessor will be blinded the treatment group. The clinician providing treatment will be blinded to outcomes.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cervical-cranial dry needling
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive cervical-cranial dry needling, thoracic manipulation, and exercise.
Arm Title
Orthopedic Manual Therapy
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will receive orthopedic manual therapy to cervical spine, thoracic manipulation, and exercise.
Intervention Type
Other
Intervention Name(s)
Cervical-cranial dry needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Orthopedic manual therapy
Intervention Description
Orthopedic Manual Therapy (OMT) that includes either mobilization or manipulation to the cervical spine applied pragmatically to the most symptomatic level.
Intervention Type
Other
Intervention Name(s)
Thoracic Manipulation
Intervention Description
Thoracic Manipulation (applied pragmatically) to the levels determined to be provocative or hypomobile.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Patient Education
Intervention Description
Patients will receive education regarding their headache condition, proper performance of their symptom management technique, posture.
Primary Outcome Measure Information:
Title
Change in NPRS headache intensity
Description
Average and most intense in the last week will be recorded using a 0 (no headache) to 10 (most intense)
Time Frame
Baseline, 1 week, 1 month, 3 months, 12 months.
Secondary Outcome Measure Information:
Title
Change in disability using Neck Disability Index
Description
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.
Time Frame
Baseline 1 week, 1 month, 3 months, 12 months
Title
Change in disability using Headache Disability Index (HDI)
Description
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.
Time Frame
Baseline, 1 week, 1 month, 3 months, 12 months
Title
Leeds Assessment of Neuropathic Signs and Symptoms (LANSS)
Description
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.
Time Frame
Baseline
Title
Change in Medication intake
Description
Patients will identify the medications + dosage they have consumed to treat their headache in the past week.
Time Frame
Baseline, 1 week, 1 month, 3 months, 12 months
Title
Patient Satisfaction
Description
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).
Time Frame
1 month
Title
Health care utilization
Description
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.
Time Frame
3 and 12 months
Title
SANE Percent Recovery
Description
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.
Time Frame
1 month
Title
Change in current NPRS neck or headache intensity
Description
Current level of headache or neck pain on a scale ranging from 0 (no headache) to 10 (most intense)
Time Frame
Baseline and Immediately post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Griswold, PhD
Phone
330-941-2419
Email
dwgriswold@ysu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Griswold, PhD
Organizational Affiliation
Associate Professor at Youngstown State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Youngstown State University
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David W Griswold, PhD, DPT
Phone
330-941-2419
Email
dwgriswold@ysu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29037632
Citation
Sedighi A, Nakhostin Ansari N, Naghdi S. Comparison of acute effects of superficial and deep dry needling into trigger points of suboccipital and upper trapezius muscles in patients with cervicogenic headache. J Bodyw Mov Ther. 2017 Oct;21(4):810-814. doi: 10.1016/j.jbmt.2017.01.002. Epub 2017 Jan 6.
Results Reference
background
PubMed Identifier
24623124
Citation
France S, Bown J, Nowosilskyj M, Mott M, Rand S, Walters J. Evidence for the use of dry needling and physiotherapy in the management of cervicogenic or tension-type headache: a systematic review. Cephalalgia. 2014 Oct;34(12):994-1003. doi: 10.1177/0333102414523847. Epub 2014 Mar 12.
Results Reference
background
PubMed Identifier
26136602
Citation
Bond BM, Kinslow C. Improvement in clinical outcomes after dry needling in a patient with occipital neuralgia. J Can Chiropr Assoc. 2015 Jun;59(2):101-10.
Results Reference
background

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

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