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

100 Participants Needed

Trial Summary

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.

What data supports the effectiveness of this treatment for headaches?

Research shows that both dry needling and manual therapy can reduce neck pain intensity and improve neck movement. In particular, manual therapy has been effective in reducing pain sensitivity and improving neck function, which may be beneficial for treating headaches related to neck issues. ^{1 2 3 4 5}

Is dry needling generally safe for humans?

A study surveyed physiotherapists in Ireland about adverse events (unwanted side effects) from trigger point dry needling and found no existing studies on its safety, suggesting limited data on potential risks. ^{1 3 4 6 7}

How does the treatment of dry needling and manual therapy for headaches differ from other treatments?

Dry needling and manual therapy for headaches are unique because they target myofascial trigger points (tight areas in muscles) to relieve tension and pain, which is different from standard headache treatments that often focus on medication. This approach combines physical techniques to improve muscle function and reduce pain, offering an alternative for those who may not respond well to traditional drug therapies. ^{1 2 3 4 8}

What is the purpose of this trial?

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.

Research Team

David Griswold, PhD

Principal Investigator

Associate Professor at Youngstown State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

February 2015 erratum. [2015]

2. United States 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. [2022]

3. England 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The Effect of Adding Dry Needling to Physical Therapy in the Treatment of Cervicogenic Headache: A Randomized Controlled Trial. [2022]

5. United States 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The utilization of dry needling and an upper extremity exercise program for individuals with cervicogenic headaches: A pilot study. [2022]

8. England 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. [2022]