Dry Needling for Cervicogenic Headache

NCT04305223 | Completed

• 1 other identifier: IRB00114985
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blinded randomized clinical trial. The primary aim of this study is to compare the effectiveness of dry needling of myofascial trigger points in the muscles of the head and cervical spine in addition to an upper extremity strengthening/stretching exercise program compared to a dry needling group alone on pain scores, cervical range of motion, pain sensitivity and changes in severity and frequency of pain symptoms in individuals with cervicogenic headache.

Conditions

Headache; Cervicogenic Headache

Keywords

Headache; Dry Needling

Outcome Measures

Primary Outcomes (6)

• Change in visual analog score for pain level

  Pain is reported using a Visual Analog Scale from 0-10 and evaluates the frequency, severity and duration of the pain. Higher score indicates worse outcome.

  Baseline, Weeks 1 to 4 post intervention

• Change in pain pressure threshold (PPT)

  Pressure algometry is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. Measured with a pressure algometer: 0-50 KPa/s (kilopascal/second squared), minimum score representing increased pain to light touch/measuring allodynia.

  Baseline, Weeks 1 to 4 post intervention

• Change in cervical range of motion

  Will measure C1-2 Active Range of Motion, min score, 0; max score 50 degrees, lower score more limited (worse outcome).

  Baseline, Weeks 1 to 4 post intervention

• Functional outcome measure: Change in neck disability index

  Score ranges from 0-50 points: higher scores indicate higher levels of disability; Minimal detectable change (MDC), 5 points.

  Baseline, Weeks 1 to 4 post intervention

• Functional outcome measure: Change in headache disability index

  Score ranges from 0-72: 0 is no disability, 72 is more severe disability. Minimally Clinically Important Difference (MCID) is 29 points.

  Baseline, Weeks 1 to 4 post intervention

• Change in Pain Frequency-Severity-Duration (PFDS) Scale

  PFSD scale ranges from 1-140 with higher scores indicative of higher disability. There is a composite score that ranges from 0-140. Higher score correlates with worse outcome.

  Baseline, Weeks 1 to 4 post intervention

Study Arms (2)

Dry needling and upper extremity stretching program Arm

EXPERIMENTAL

Participants will receive a combination of dry needling and upper extremity stretching. * Dry needling in regions of the head and cervical spine will be positioned supine, sidelying or prone with the relevant myofascial trigger points treated using a Seirin L- type 30 mm needle (Seirin America, Inc., Weymouth, MA). The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 5 minutes. * A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter.

Procedure: Dry Needling; Other: Upper extremity stretching program

Dry Needling Arm

ACTIVE COMPARATOR

Dry needling in regions of the head and cervical spine will be positioned supine, sidelying or prone with the relevant myofascial trigger points treated using a Seirin L- type 30 mm needle (Seirin American, Inc., Weymouth, MA). The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 5 minutes.

Procedure: Dry Needling

Interventions

Dry Needling PROCEDURE

Dry Needling is a treatment technique whereby a sterile, single-use, fine filament needle is inserted into the muscle to assist with decreasing pain and improving function through the release of myofascial trigger points (knots in the muscle).

Also known as: Myofascial trigger point dry needling, Intramuscular stimulation

Dry Needling Arm; Dry needling and upper extremity stretching program Arm

Upper extremity stretching program OTHER

A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter

Dry needling and upper extremity stretching program Arm

Eligibility Criteria

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

You may qualify if:

• Unilateral headache (HA) without side shift
• H/o pain triggered by neck movement
• Limitation in cervical range of motion
• Ispilateral neck, shoulder or arm pain
• Intermittent pain with episodes varying in duration
• Head and neck pain is non-throbbing in nature

You may not qualify if:

• Use of anti-coagulation medicine (except low dose aspirin)
• Pregnancy
• Acute or uncontrolled medical illness
• Opioid use within six months
• Fibromyalgia or diffuse painful syndromes in the UE or LE
• Substance abuse
• Presence of fever, vomiting or visual changes

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Headache; Post-Traumatic Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Kathleen Geist, PT, DPT

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators assessing outcome measures will be blinded to participants' group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: single-blinded randomized clinical trial

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 12, 2020
• Study Start: February 12, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

US (1)