What side effects are associated with this type of intervention?

Cervical-cranial dry needling, used for treating cervicogenic headache, may cause mild side effects such as soreness, bleeding, or bruising at the needle insertion sites. Orthopedic manual therapy, including spinal mobilization, is generally safe but can occasionally lead to temporary discomfort, increased pain, or muscle stiffness. Both treatments are considered low-risk when performed by trained professionals.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments directly targeting Cervicogenic Headache (CGH) similar to cervical-cranial dry needling and orthopedic manual therapy. However, these non-pharmacologic interventions are commonly used in clinical practice to manage CGH symptoms. Dry needling is a technique used to release muscle trigger points, while orthopedic manual therapy involves spinal mobilization techniques. Both methods aim to alleviate pain and improve function in patients with CGH.

What other types of research exist?

Promising novel alternatives for Cervicogenic Headache patients include remote electrical neuromodulation and transcranial magnetic stimulation (TMS). Remote electrical neuromodulation has shown significant pain relief and minimal adverse events in clinical trials. TMS has demonstrated efficacy in providing pain freedom and sustained pain relief, making it a viable second-line intervention for those who do not respond to first-line therapies.

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Dry Needling vs. Manual Therapy for Headaches

N/A

Recruiting

Led By David Griswold, PhD

Research Sponsored by Youngstown State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Headache frequency of at least 1 per week over a period greater than 3 months

18 years or older

Must not have

Non-English speaking patients

Tension-type headache

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline 1 week, 1 month, 3 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares dry needling and orthopedic manual therapy for patients with headaches caused by neck problems. Dry needling uses thin needles to relieve muscle tension, while manual therapy involves hands-on adjustments to the neck. Both treatments aim to reduce headache pain by addressing issues in the neck. Dry needling is a treatment technique used by clinicians to relieve symptoms in patients with tension-type headache (TTH), cervicogenic headache (CGH), or migraine.

Who is the study for?

This trial is for adults over 18 with cervicogenic headaches (CGH) occurring at least once a week for more than three months. Participants must meet specific criteria and have neck dysfunction. It's not for those with mild headache pain, non-English speakers, certain medical conditions or surgeries, metal allergies, migraine or tension-type headaches, needle phobia, or cervical arterial issues.

What is being tested?

The study compares the effectiveness of cervical-cranial dry needling versus orthopedic manual therapy in managing CGH symptoms. Both treatments are accompanied by patient education, thoracic manipulation, and exercise. The outcomes will be measured at various intervals up to one year.

What are the potential side effects?

Potential side effects may include discomfort at the needle site from dry needling and soreness from manual therapy. There could also be temporary increased headache or neck pain following treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had headaches at least once a week for more than 3 months.

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I am 18 years old or older.

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I have had headaches at least once a week for more than 3 months.

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I have trouble moving parts of my body even when helped.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I experience tension-type headaches.

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I do not have conditions like cancer, spinal cord issues, fractures, metabolic diseases, rheumatoid arthritis, or long-term steroid use that would prevent me from receiving certain treatments.

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My headache does not worsen with certain neck movements.

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I am extremely afraid of needles.

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I have had surgery on my neck or upper back.

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I experience headaches that suggest a neck artery issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline 1 week, 1 month, 3 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline 1 week, 1 month, 3 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 1 week, 1 month, 3 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in NPRS headache intensity

Secondary study objectives

Change in Medication intake

Change in current NPRS neck or headache intensity

Change in disability using Headache Disability Index (HDI)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cervical-cranial dry needlingExperimental Treatment4 Interventions

Patients randomized to this arm will receive cervical-cranial dry needling, thoracic manipulation, and exercise.

Group II: Orthopedic Manual TherapyActive Control4 Interventions

Patients randomized to this arm will receive orthopedic manual therapy to cervical spine, thoracic manipulation, and exercise.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cervical-Cranial Dry Needling (Trigger Point Release) involves inserting thin needles into specific muscle trigger points to relieve tension and pain by disrupting the pain cycle and promoting muscle relaxation. Orthopedic Manual Therapy (Spinal Mobilization) includes techniques such as thrust and non-thrust mobilizations to the cervical spine, which aim to improve joint mobility, reduce muscle tension, and alleviate pain by restoring normal movement patterns. These treatments are significant for Cervicogenic Headache patients as they directly target the musculoskeletal sources of their headaches, potentially providing relief from pain and improving overall function.