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

Primary Purpose

Cervicogenic Headaches

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling,Thrust Manipulation
Exercise,Non-thrust Mobilization
Sponsored by
Alabama Physical Therapy & Acupuncture
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headaches

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Physical Therapy & Acupuncture

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling,Thrust Manipulation

Exercise,Non-thrust Mobilization

Arm Description

Outcomes

Primary Outcome Measures

Change in Headache Intensity (NPRS) (Rating Score)
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Change in Headache Frequency (Number of headaches in the last week)
Number of headaches in the last week
Change in Disability (NDI 0-50 points)
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 Outcome Measures

Change in Global Rating of Change Score
Change in Medication Intake (Frequency of medication intake in last week)
Change in Headache Duration (Total hours of headaches in the last week)
Total hours of headaches in the last week

Full Information

First Posted
February 10, 2015
Last Updated
June 4, 2018
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT02373605
Brief Title
Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache
Official Title
Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache: a Multi-center Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headaches

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling,Thrust Manipulation
Arm Type
Experimental
Arm Title
Exercise,Non-thrust Mobilization
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dry Needling,Thrust Manipulation
Other Intervention Name(s)
Spinal Manipulation, Dry Needling
Intervention Description
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
Intervention Name(s)
Exercise,Non-thrust Mobilization
Other Intervention Name(s)
Exercise, Non-thrust Mobilization
Intervention Description
Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.
Primary Outcome Measure Information:
Title
Change in Headache Intensity (NPRS) (Rating Score)
Description
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Headache Frequency (Number of headaches in the last week)
Description
Number of headaches in the last week
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Title
Change in Disability (NDI 0-50 points)
Description
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.
Time Frame
Baseline, 1 week, 4 weeks, 3 months
Secondary Outcome Measure Information:
Title
Change in Global Rating of Change Score
Time Frame
1 week, 4 weeks, 3 months
Title
Change in Medication Intake (Frequency of medication intake in last week)
Time Frame
Baseline, 3 months
Title
Change in Headache Duration (Total hours of headaches in the last week)
Description
Total hours of headaches in the last week
Time Frame
Baseline, 1 week, 4 weeks, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dunning, DPT PhD
Organizational Affiliation
American Academy of Manipulative Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Physical Therapy & Acupuncture
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33065273
Citation
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. Erratum In: Spine J. 2021 May 22;:
Results Reference
derived

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

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