Dry Needling + Exercises for Neck Pain

Not yet recruiting at 1 trial location

Overseen By Ray Lunasin, PT, DPT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Cancer, Neuropathic pain, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how dry needling with electrical stimulation (a technique involving the insertion of thin needles into muscles) can help people with restless legs syndrome sleep better, feel less discomfort, and improve daily function. It will test the addition of this treatment to a home exercise program. The trial seeks participants diagnosed with restless legs syndrome. Those who experience uncomfortable sensations in their legs that disrupt sleep or daily activities might be a good fit. As an unphased trial, this study offers an opportunity to explore innovative treatment options for restless legs syndrome.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that dry needling with electrical stimulation is safe for individuals with restless legs syndrome?

Research has shown that dry needling can reduce pain and improve movement for various conditions. In one study, almost 74% of patients experienced less pain after treatment. However, about 20% of patients reported mild side effects like bruising or bleeding, which are usually not serious.

In this study, researchers use dry needling with electrical stimulation. While this method differs slightly, the main concept remains the same. Overall, dry needling appears well-tolerated, with only mild side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about dry needling with electrical stimulation for neck pain because it offers a unique approach compared to standard treatments like physical therapy, medications, or manual manipulation. Unlike traditional methods, this technique combines the precision of dry needling with the added benefit of electrical stimulation, which may enhance muscle relaxation and pain relief. This dual action could potentially provide faster and more effective results, offering hope for individuals seeking relief from persistent neck pain.

What evidence suggests that dry needling with electrical stimulation is effective for restless legs syndrome?

Research shows that dry needling with electrical stimulation (DNES), which participants in this trial may receive, can reduce pain and improve mobility. Studies have found that dry needling lowers pain levels and lessens disability in people with neck pain. For those with long-term pain, dry needling improved both pain and function in the short and mid-term. DNES can also raise the threshold at which people feel pain from pressure, aiding in symptom management. While dry needling is often used for neck pain, researchers are still studying its effectiveness for restless legs syndrome. ^{3 6 7 8 9}

Who Is on the Research Team?

Ray Lunasin, PT, DPT, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with chronic neck pain lasting over 3 months and sleep problems, as indicated by a score of 8 or higher on the Insomnia Severity Index. It's not suitable for pregnant individuals, those lacking English proficiency to complete surveys, people involved in neck pain litigation, or those with central nervous system disorders, prior neck surgery, systemic joint diseases like rheumatoid arthritis, serious conditions such as cancer or immunocompromised states.

Inclusion Criteria

I have trouble sleeping, scoring 8 or more on the Insomnia Severity Index.

I have had neck pain for more than 3 months.

Exclusion Criteria

I have a condition like rheumatoid arthritis affecting my joints.

I have a disorder affecting my brain or nerves.

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 with electrical stimulation to the lower extremities

3 weeks

Weekly visits

Follow-up

Participants are monitored for changes in symptom severity, sleep quality, and quality of life

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dry Needling
• Home Exercise Program

Trial Overview

The study investigates if combining dry needling with a home exercise program can improve sleep quality and duration for people suffering from long-term neck pain and disturbed sleep. Participants will receive both treatments and their effects on sleep will be compared.

How Is the Trial Designed?

Group I: Dry needling with electrical stimulation Experimental Treatment 1 Intervention

Participants with restless legs syndrome will receive dry needling with electrical stimulation to the lower extremities

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]

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]

Citations

1.

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10469395/

Effectiveness of Dry Needling in Improving Pain and ...

Our meta-analysis supports the use of dry needling to improve pain and functional capacity in patients with chronic neck pain at short- and mid-term intervals.

3.

nature.com

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

Dry needling in active or latent trigger point in patients with ...

The application of DDN on an active-MTrP in the upper trapezius muscle shows greater improvements in pain intensity after 1 week and 1 month ...

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.

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 ...

7.

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

Amongst all body regions, 73.8% reported improved pain; 38.5% reported improved strength; 46.2% reported improved gait; and 70.6% reported ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4101552/

Adverse events following trigger point dry needling

Almost 20% of treatments with TrP-DN by the physiotherapists in this study resulted in a mild AE. Common AEs include bruising, bleeding, and pain.

9.

mdpi.com

mdpi.com/2077-0383/9/10/3300

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 ...