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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dry needling, combined with exercise, can help individuals with long-term neck pain and sleep difficulties. Dry needling uses thin needles to relieve muscle pain. Participants will either engage in exercises alone or a combination of dry needling and exercises. The trial seeks individuals who have experienced neck pain for over three months and also have sleep problems. As an unphased trial, participants can contribute to innovative research that may enhance treatment options for neck pain and sleep issues.

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.

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 pain. Many individuals report that it reduces their pain and increases comfort when pressure is applied to sore areas. One study found that dry needling provides short-term pain relief comparable to other treatments.

Regarding side effects, dry needling is usually well-tolerated. Some individuals might experience minor issues like soreness or bruising, but these are uncommon. Overall, dry needling is considered a safe option for managing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about dry needling combined with therapeutic exercise for neck pain and sleep disorders because it offers a unique approach by potentially addressing muscle trigger points directly. Unlike conventional treatments such as medication or physical therapy alone, dry needling aims to target and relieve muscle tension and pain more precisely and rapidly. This method could provide faster relief from symptoms and improve sleep quality, offering a promising alternative to existing therapies.

What evidence suggests that this trial's treatments could be effective for neck pain and sleep disorders?

Research has shown that dry needling, particularly when combined with exercise, might help reduce neck pain. In this trial, one group will receive both dry needling and therapeutic exercise, while another group will receive only therapeutic exercise. Some studies indicate that dry needling can lessen pain and improve sleep. For people with fibromyalgia, dry needling has improved quality of life by reducing pain and anxiety. Although the evidence remains limited, it suggests that dry needling could help manage chronic neck pain. Overall, it appears promising as an additional treatment to reduce discomfort and enhance well-being. ^{1 2 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 (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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9917679/

Clinical Effectiveness of Dry Needling in Patients with ... In general, there was low quality evidence suggesting a positive effect at mid- and long-term for neck pain, but not for shoulder pain (mid-term results were in ...

2. istanbulmedicaljournal.org istanbulmedicaljournal.org/articles/impact-of-trigger-point-dry-needling-on-neck-pain-sleep-and-depression-in-patients-with-fibromyalgia/imj.galenos.2023.66502

Impact of Trigger Point Dry Needling on Neck Pain, Sleep ... MrTP DN improves pain, neck disability, sleep quality, anxiety, depression, and quality of life in patients with FMS. For better management of ...

3. nature.com nature.com/articles/s41598-022-07063-0

Dry needling in active or latent trigger point in patients with ... The active-MTrP-DDN-group reduced pain intensity more than non-MTrP-DDN-group after a week and a month (P < 0.01), as well as showing the ...

4. jospt.org jospt.org/doi/10.2519/jospt.2017.7096

The Effectiveness of Trigger Point Dry Needling for ... Studies provided evidence that dry needling may decrease pain and increase pressure pain threshold when compared to control/sham or other treatment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03844802

Effectiveness of Dry Needling in Chronic Neck Pain. Objectives: To investigate the effect of combining real or placebo dry needling with therapeutic exercise in self-reported pain, pressure pain sensitivity, ...

6. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/143187-patient-perceived-benefits-and-adverse-events-of-dry-needling

Patient-Perceived Benefits and Adverse Events of Dry Needling Dry needling (DN) has emerged as a safe and effective physical therapy technique to address neuromusculoskeletal pain and dysfunctions; however, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1360859224003395

Effectiveness of deep dry needling combined with ... Adding deep dry needling to stretching for the treatment of MTP may be an effective approach for the treatment of pain in patients with MTPs.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7602246/

Effectiveness of Dry Needling for Myofascial Trigger Points ... Low to moderate evidence suggests that dry needling can be effective for improving pain intensity and pain-related disability in individuals with neck pain ...