Dry Needling vs. Manual Therapy for Headaches

Overseen By David Griswold, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Youngstown State University

Must not be taking: Corticosteroids

Disqualifiers: Migraine, Malignancy, Myelopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different treatments for cervicogenic headaches, which originate from neck issues. One group will receive cervical-cranial dry needling, a technique involving the insertion of thin needles into muscles. The other group will receive orthopedic manual therapy, which uses hands-on maneuvers to ease neck problems. The goal is to determine which treatment better reduces headache symptoms over time. Individuals who experience headaches at least once a week for over three months and feel neck stiffness may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding effective treatments for cervicogenic headaches.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dry needling is generally safe for treating headaches, reducing pain without causing serious side effects. Most people notice an improvement in their headache symptoms after undergoing dry needling.

Studies have also confirmed that orthopedic manual therapy is safe and effectively reduces the frequency and intensity of headaches. The low chance of side effects makes it a reliable choice for many.

Both treatments are well-tolerated and have demonstrated effectiveness in reducing headache symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for headaches because they offer unique approaches compared to standard care, which often involves medication or traditional physical therapy. Cervical-cranial dry needling is distinctive because it targets specific muscle trigger points with fine needles, potentially providing relief by releasing muscle tension directly at the source. Orthopedic manual therapy stands out by focusing on hands-on manipulation of the cervical spine, aiming to improve spinal alignment and reduce headache frequency through physical adjustments. Both techniques are combined with thoracic manipulation and exercise, offering a comprehensive approach that may enhance overall effectiveness for headache sufferers.

What evidence suggests that this trial's treatments could be effective for CGH?

This trial will compare cervical-cranial dry needling with orthopedic manual therapy for treating headaches. Research has shown that dry needling, one of the treatments in this trial, can reduce the frequency of tension-type headaches and improve quality of life. It may also help reduce active trigger points, which are tight spots in muscles that cause pain. However, methods can vary, and more evidence is still being gathered.

Orthopedic manual therapy, another treatment option in this trial, has well-documented benefits for headaches. Studies have shown it can reduce the number of headache episodes and improve symptoms over time. Manual therapy often involves specific movements and techniques to relieve pain and enhance mobility. Overall, manual therapy is widely accepted as an effective treatment for headaches caused by neck problems, known as cervicogenic headaches. ^{1 3 6 7 8}

Who Is on the Research Team?

David Griswold, PhD

Principal Investigator

Associate Professor at Youngstown State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I experience tension-type headaches.

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.

You are currently involved in a lawsuit related to neck pain or headaches.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cervical-cranial dry needling or orthopedic manual therapy, along with thoracic manipulation and exercise, 2x/week for 2 weeks and then 1-2x/week for 2 weeks

4 weeks

6-8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with outcomes collected at 1 week, 1 month, 3 months, and 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cervical-cranial dry needling
• Orthopedic manual therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Cervical-cranial dry needling Experimental Treatment 4 Interventions

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

Group II: Orthopedic Manual Therapy Active Control 4 Interventions

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

Cervical-cranial dry needling is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Dry Needling for:

• Cervicogenic Headache
• Musculoskeletal Pain
• Neuromusculoskeletal Conditions

Approved in European Union as Dry Needling for:

• Cervicogenic Headache
• Musculoskeletal Pain
• Neuromusculoskeletal Conditions

Approved in Canada as Dry Needling for:

• Cervicogenic Headache
• Musculoskeletal Pain
• Neuromusculoskeletal Conditions

Who Is Running the Clinical Trial?

Youngstown State University

Lead Sponsor

Trials

27

Recruited

2,000+

Franklin Pierce University

Collaborator

Trials

16

Recruited

1,100+

Published Research Related to This Trial

The original study compared the effectiveness of trigger point dry needling and manual therapy for treating chronic neck pain, providing insights into short-term outcomes for patients.

The correction highlights the importance of accurate reporting in clinical trials, ensuring that findings on treatment efficacy are reliable and can guide future therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

February 2015 erratum. [2015]

In a study of 36 patients with chronic neck pain, orthopedic manual therapy (OMT) was found to be particularly effective, reducing mechanical hyperalgesia and pain catastrophizing, which are important factors in pain perception.

Both OMT and dry needling with stretching (DN-S) improved cervical range of motion and reduced neck disability, but only OMT showed significant clinical relevance in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study. Campa-Moran, I., Rey-Gudin, E., Fernández-Carnero, J., et al.[2022]

In a study involving 39 physiotherapists and 7629 treatments, trigger point dry needling (TrP-DN) was found to have a high incidence of mild adverse events (AEs), with 1463 reported cases, but no significant AEs occurred, indicating a very low risk of serious complications (≤ 0.04%).

Common mild AEs included bruising (7.55%) and bleeding (4.65%), but the overall safety profile suggests that TrP-DN is a safe treatment option for myofascial pain when performed by trained physiotherapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists. Brady, S., McEvoy, J., Dommerholt, J., et al.[2022]

In a study of 101 participants with chronic mechanical neck pain, dry needling combined with manual therapy (DN+MT) significantly reduced pain intensity and improved pain pressure threshold compared to sham dry needling with manual therapy (SDN+MT).

The DN+MT group showed substantial improvements in cervical range of motion and neck disability after treatment, indicating that this combined approach is more effective for managing chronic neck pain than the sham treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Gallego-Sendarrubias, GM., Rodríguez-Sanz, D., Calvo-Lobo, C., et al.[2021]

In a study involving 69 patients with cervicogenic headache, dry needling combined with conventional physiotherapy significantly reduced headache intensity and neck disability compared to both sham and control groups, with improvements observed at multiple follow-up points (1, 3, and 6 months).

The dry needling group also showed greater cervical range of motion and better performance of deep cervical flexor muscles compared to the other groups, indicating its potential benefits in managing cervicogenic headaches, although the overall clinical significance of these improvements was considered small.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Adding Dry Needling to Physical Therapy in the Treatment of Cervicogenic Headache: A Randomized Controlled Trial. Mousavi-Khatir, SR., Fernández-de-Las-Peñas, C., Saadat, P., et al.[2022]

In a study involving 7 participants with cervicogenic headache, a combination of dry needling and neuromuscular reeducation exercises led to significant improvements in cervical range of motion and neck pain-related disability over a 4-week treatment period.

The results suggest that this treatment approach could effectively reduce pain and disability in individuals suffering from cervicogenic headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utilization of dry needling and an upper extremity exercise program for individuals with cervicogenic headaches: A pilot study. Geist, K., Frierson, E., Hudson, O., et al.[2022]

A single session of dry needling (DN) or myofascial release (MR) significantly increased pressure pain threshold (PPT) in individuals with chronic neck pain, indicating both methods can effectively reduce pain sensitivity immediately after treatment.

All groups, including the sham DN group, reported a decrease in neck pain intensity, suggesting that both DN and MR provide immediate pain relief that is superior to placebo, although further research is needed to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Effects of Dry Needling and Myofascial Release on Local and Widespread Pressure Pain Threshold in Individuals With Active Upper Trapezius Trigger Points: A Randomized Clinical Trial. Stieven, FF., Ferreira, GE., de Araújo, FX., et al.[2021]

Three studies indicated that dry needling, when added to conventional physiotherapy, resulted in statistically significant improvements in tension-type and cervicogenic headaches, particularly noting a 45 mm reduction in pain intensity on the VAS scale.

While no significant differences were found between groups, and no adverse events were reported, the evidence suggests that dry needling could be a beneficial adjunct to physiotherapy for headache management, warranting further research for stronger conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the use of dry needling and physiotherapy in the management of cervicogenic or tension-type headache: a systematic review. France, S., Bown, J., Nowosilskyj, M., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11051369/

Effects of Dry Needling on Active Myofascial Trigger Points ...

Dry needling demonstrated positive effects in reducing the number of active trigger points and improving the short-term headache intensity in ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33609358/

Dry Needling for the Treatment of Tension-Type, ...

The synthesis of results showed that dry needling could significantly improve headache frequency, health-related quality of life, trigger point ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2173580822000621

Review article Effectiveness of dry needling for headache

There is moderate evidence that acupuncture is effective for the prevention of migraine attacks5, 6 and for the management of tension-type headache.

4.

tandfonline.com

tandfonline.com/doi/full/10.1586/14737175.2016.1152889

Dry needling for headaches presenting active trigger points

Recent meta-analyses have found that trigger point dry needling (TrP-DN) may be effective for the treatment of upper quarter pain syndromes.

5.

mdpi.com

mdpi.com/2077-0383/14/5/1740

Expert Consensus on Dry Needling Practices for Headache

Although current evidence supports the use of dry needling for reducing headache pain, needling approaches are inconsistent among published studies, and no ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11900175/

Expert Consensus on Dry Needling Practices for Headache

For headaches, a previous review reported that DN reduced headache pain in all eight studies analyzed, including migraine [54]. Yet, Vázquez- ...

7.

mdpi.com

mdpi.com/2077-0383/14/15/5320

Dry Needling for Tension-Type Headache: A Scoping ...

DN interventions differed in technique. All studies included indicated favorable outcomes with improvements in headache symptoms. No serious adverse effects ...

8.

journals.lww.com

journals.lww.com/md-journal/fulltext/2019/02220/a_randomized_trial_of_trigger_point_dry_needling.35.aspx

A randomized trial of trigger point dry needling versus sham

Conclusions: The results of this clinical trial suggest that trigger point dry needling in patients with chronic tension-type headache is effective and safe in ...