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

Not Applicable

Completed

• Conditions: Cervicogenic Headaches
• Interventions: Other: Dry Needling,Thrust Manipulation; Other: Exercise,Non-thrust Mobilization

• Registration Number: NCT02373605
• Lead Sponsor: Alabama Physical Therapy & Acupuncture

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

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-02-27
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry Needling,Thrust Manipulation	Dry Needling,Thrust Manipulation	-
Exercise,Non-thrust Mobilization	Exercise,Non-thrust Mobilization	-

Primary Outcome Measures

Name	Time	Method
Change in Headache Intensity (NPRS) (Rating Score)	Baseline, 1 week, 4 weeks, 3 months	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)	Baseline, 1 week, 4 weeks, 3 months	Number of headaches in the last week
Change in Disability (NDI 0-50 points)	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 Outcome Measures

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

Trial Locations

Locations (1)

Alabama Physical Therapy & Acupuncture; 🇺🇸 Montgomery, Alabama, United States