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

Cervicogenic Headaches Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373605
• Other study ID #: AAMT0001
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: May 15, 2018

Study information

• Verified date: June 2018
• Source: Alabama Physical Therapy & Acupuncture
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervicogenic Headaches
• Headache
• Post-Traumatic Headache

Intervention

Other:
• Dry Needling,Thrust Manipulation
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.
• Exercise,Non-thrust Mobilization
Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.

Locations

Country	Name	City	State
United States	Alabama Physical Therapy & Acupuncture	Montgomery	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Headache Intensity (NPRS) (Rating Score)	Rating Score. Baseline score must exceed 2/10 to be included in the study.	Baseline, 1 week, 4 weeks, 3 months
Primary	Change in Headache Frequency (Number of headaches in the last week)	Number of headaches in the last week	Baseline, 1 week, 4 weeks, 3 months
Primary	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.	Baseline, 1 week, 4 weeks, 3 months
Secondary	Change in Global Rating of Change Score		1 week, 4 weeks, 3 months
Secondary	Change in Medication Intake (Frequency of medication intake in last week)		Baseline, 3 months
Secondary	Change in Headache Duration (Total hours of headaches in the last week)	Total hours of headaches in the last week	Baseline, 1 week, 4 weeks, 3 months