Dry Needling and Exercise for Neck Pain and Sleep Disorders

Overseen By Ray Lunasin, P.T., D.P.T.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants

Disqualifiers: CNS disorders, Systemic joint disease, Immunocompromised, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 5 weeks

28 Participants Needed

Trial Summary

What is the purpose of this trial?

Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anticoagulant therapy (blood thinners), you may not be eligible to participate.

What data supports the effectiveness of the treatment Dry Needling and Exercise for Neck Pain and Sleep Disorders?

Research shows that dry needling can help reduce neck pain by targeting trigger points (tight muscle areas) in the neck muscles, although some studies suggest it may not add extra benefits when combined with other therapies. It has been compared to other treatments like trigger point injections, showing similar effects in reducing neck pain. ^{1 2 3 4 5}

Is dry needling safe for humans?

Dry needling is generally well tolerated, with most adverse events being mild, but there have been rare reports of severe complications, such as a spinal epidural hematoma (a type of bleeding in the spine). It's important for practitioners to take precautions, especially when needling near the spine. ^{6 7 8 9 10}

How is the treatment dry needling unique for neck pain and sleep disorders?

Dry needling is unique because it involves inserting thin needles directly into muscle knots (trigger points) to relieve tension and pain, which is different from other treatments like medication or physical therapy that do not target these specific points directly. ^{1 3 9 11 12}

Research Team

Ray Lunasin, P.T., D.P.T.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 18-75 who have had neck pain for more than 3 months and are experiencing sleep problems, as indicated by a score of 8 or higher on the Insomnia Severity Index. Participants must understand and be able to follow study procedures throughout.

Inclusion Criteria

I understand and can follow the study's procedures.

I have had neck pain for more than 3 months.

Presence of sleep disturbance defined as a score ≥ 8 on the Insomnia Severity Index

Exclusion Criteria

Pregnancy

I have had surgery on my neck or upper back.

Insufficient English-language skills to complete all questionnaires

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dry needling and therapeutic exercise to assess effects on sleep duration and quality

5 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Long-term follow-up

Participants are monitored for retention, adverse responses, and adherence

1 year

Treatment Details

Interventions

• Dry Needling
• Therapeutic Exercise

Trial Overview The study is testing whether dry needling, which involves inserting thin needles into muscles, combined with therapeutic exercises can improve sleep in people suffering from chronic neck pain and disturbed sleep.

Participant Groups

Group I: Dry Needling and Therapeutic Exercise Experimental Treatment 2 Interventions

Group II: Therapeutic Exercise Alone Active Control 1 Intervention

Dry Needling is already approved in United Kingdom, United States for the following indications:

Approved in United Kingdom as Dry Needling for:

• Knee osteoarthritis pain management
• Muscle strength improvement
• Leg function enhancement

Approved in United States as Dry Needling for:

• Chronic knee pain relief
• Musculoskeletal pain management
• Myofascial pain syndrome treatment

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

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]

Dry needling (DN) significantly reduced muscle activity and pain in the upper trapezius muscle of participants with latent trigger points, as shown by lower surface electromyography (sEMG) readings compared to a sham treatment.

Participants receiving DN also experienced a higher pressure pain threshold (PPT) at 72 hours post-treatment, indicating improved pain tolerance compared to those in the sham group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in electromyographic activity of latent trigger points after a dry needling intervention: a randomised controlled trial. Sánchez-Infante, J., Bravo-Sánchez, A., Esteban-García, P., 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]

Dry needling significantly reduces pain intensity in individuals with neck pain associated with trigger points, showing immediate and short-term benefits compared to sham treatments and other physical interventions, based on a review of 28 trials.

The evidence suggests that dry needling can improve pain-related disability in the short term, but it does not show significant effects on cervical range of motion or pressure pain sensitivity compared to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Dry Needling for Myofascial Trigger Points Associated with Neck Pain Symptoms: An Updated Systematic Review and Meta-Analysis. Navarro-Santana, MJ., Sanchez-Infante, J., Fernández-de-Las-Peñas, C., et al.[2020]

Combining dry needling with other physical therapy interventions significantly reduces pain intensity in the short-term and midterm for individuals with neck pain related to trigger points, with a standardized mean difference of -1.46 at short-term.

The combination also shows a small positive effect on pain-related disability and improves pressure pain thresholds in the short-term, but no significant long-term benefits were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Dry Needling Effective When Combined with Other Therapies for Myofascial Trigger Points Associated with Neck Pain Symptoms? A Systematic Review and Meta-Analysis. Fernández-De-Las-Peñas, C., Plaza-Manzano, G., Sanchez-Infante, J., et al.[2023]

Dry needling is generally safe and well tolerated for treating myofascial pain, but there is a risk of severe complications, such as an acute spinal epidural hematoma, as highlighted in this case report.

Healthcare providers should exercise caution when performing dry needling near the spine, and any sudden neuropathic pain following the procedure should be evaluated immediately with advanced imaging to ensure spinal cord integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Spinal Epidural Hematoma as a Complication of Dry Needling: A Case Report. Berrigan, WA., Whitehair, CL., Zorowitz, RD.[2020]

References

1. 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]

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

Dry Needling Adds No Benefit to the Treatment of Neck Pain: A Sham-Controlled Randomized Clinical Trial With 1-Year Follow-up. [2021]

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

Effectiveness of dry needling on the lower trapezius in patients with mechanical neck pain: a randomized controlled trial. [2022]

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

Dry Needling Versus Trigger Point Injection for Neck Pain Symptoms Associated with Myofascial Trigger Points: A Systematic Review and Meta-Analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Changes in electromyographic activity of latent trigger points after a dry needling intervention: a randomised controlled trial. [2022]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Dry Needling for Myofascial Trigger Points Associated with Neck Pain Symptoms: An Updated Systematic Review and Meta-Analysis. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Dry needling in active or latent trigger point in patients with neck pain: a randomized clinical trial. [2022]

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

Is Dry Needling Effective When Combined with Other Therapies for Myofascial Trigger Points Associated with Neck Pain Symptoms? A Systematic Review and Meta-Analysis. [2023]

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

Acute Spinal Epidural Hematoma as a Complication of Dry Needling: A Case Report. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Effects of dry needling of active trigger points in the scalene muscles in individuals with mechanical neck pain: a randomized clinical trial. [2021]

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

Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial. [2022]