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NCT Number: NCT04305223

Dry Needling for Cervicogenic Headache

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.

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Cervicogenic Headache Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Traumatic Headache Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

This is a single-blinded randomized clinical trial. Eligible participants who agree to enroll in the study will be asked to attend four testing sessions. Participants in both groups will receive dry needling to the involved head and cervical muscles and the other group, in addition to receiving a dry needling intervention, will be instructed in a standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. All dry needling (using standard clean technique) will be performed by licensed physical therapists board certified in orthopaedic physical therapy and having a minimum of 5 years of experience treating patient populations with dry needling.

The aim of this research study is to compare he effectiveness of dry needling alone with dry needling and a home exercise program on pain, pain sensitivity, cervical range of motion, and changes in the severity and frequency among individuals with headache symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

Other names: Myofascial trigger point dry needling, Intramuscular stimulation

Upper extremity stretching program

Other

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

Primary outcomes

  1. Change in visual analog score for pain level

    Time frame: Baseline, Weeks 1 to 4 post intervention

    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.

  2. Change in pain pressure threshold (PPT)

    Time frame: Baseline, Weeks 1 to 4 post intervention

    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.

  3. Change in cervical range of motion

    Time frame: Baseline, Weeks 1 to 4 post intervention

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

  4. Functional outcome measure: Change in neck disability index

    Time frame: Baseline, Weeks 1 to 4 post intervention

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

  5. Functional outcome measure: Change in headache disability index

    Time frame: Baseline, Weeks 1 to 4 post intervention

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

  6. Change in Pain Frequency-Severity-Duration (PFDS) Scale

    Time frame: Baseline, Weeks 1 to 4 post intervention

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Comparison of Dry Needling Versus Upper Extremity Strengthening and Dry Needling for Individuals With Cervicogenic Headache

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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