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

NCT02373605 | Completed

• 1 other identifier: AAMT0001
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicogenic Headaches

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Change in Global Rating of Change Score

  1 week, 4 weeks, 3 months

• Change in Medication Intake (Frequency of medication intake in last week)

  Baseline, 3 months

• Change in Headache Duration (Total hours of headaches in the last week)

  Baseline, 1 week, 4 weeks, 3 months

Study Arms (2)

Dry Needling,Thrust Manipulation

EXPERIMENTAL

Other: Dry Needling,Thrust Manipulation

Exercise,Non-thrust Mobilization

ACTIVE COMPARATOR

Other: Exercise,Non-thrust Mobilization

Interventions

Dry Needling,Thrust Manipulation OTHER

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.

Also known as: Spinal Manipulation, Dry Needling

Dry Needling,Thrust Manipulation

Exercise,Non-thrust Mobilization OTHER

Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.

Also known as: Exercise, Non-thrust Mobilization

Exercise,Non-thrust Mobilization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

Location

Related Publications (1)

• 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.

  PMID: 33065273 DERIVED

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Dry Needling; Manipulation, Spinal; Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James Dunning, DPT PhD

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DPT MSc FAAOMPT

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 27, 2015
• Study Start: February 1, 2015
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

US (1)