Dry Needling for Chronic Low Back Pain

Overseen By Kunal Lohana, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ajay Wasan, MD, Msc

Disqualifiers: Back surgery, Workers' comp, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the NUN biomarker, a special body test, can track pain changes and predict who will benefit from dry needling, a therapy involving the insertion of thin needles into muscles, for chronic low back pain. It compares real dry needling to a placebo version to assess their effects on pain. The goal is to determine if this test can identify who will experience relief and if higher test levels lead to better outcomes. This study targets individuals who have experienced muscle-related low back pain daily for at least three months and have not previously tried dry needling. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future pain management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that new pain treatments should not be started within 2 weeks of enrollment, which might suggest that existing medications could be continued.

What prior data suggests that dry needling is safe for chronic low back pain?

Research has shown that dry needling is generally safe for treating muscle pain. A study of physical therapists over nine months found that serious side effects rarely occurred during dry needling sessions. Some individuals experienced mild issues like temporary pain or bruising, but these were not serious.

Other studies indicate that dry needling can help reduce pain and improve movement for those with long-term low back pain. It is considered an effective way to manage muscle pain. Overall, while minor discomfort might occur, patients usually tolerate dry needling well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Dry needling is unique because it offers a hands-on approach to relieve chronic low back pain without medications or surgery. Unlike standard treatments like pain relievers, physical therapy, or injections, dry needling uses thin needles inserted into trigger points in muscles to release tension and improve mobility. Researchers are excited about this technique because it has the potential to provide faster pain relief by directly targeting the source of discomfort in the muscles. Additionally, the sham dry needling arm in the trial helps ensure that the observed effects are due to the actual treatment, not just a placebo effect.

What evidence suggests that dry needling is effective for chronic low back pain?

Research has shown that dry needling, one of the treatments in this trial, can reduce pain and improve movement in individuals with long-term lower back pain. A review of eight studies involving 414 patients found that dry needling relieved pain. This trial will compare dry needling with sham dry needling to evaluate its effectiveness. Studies also suggest that combining dry needling with physical therapy improves movement more than using dry needling alone. It is particularly effective for treating muscle pain caused by irritation. Overall, dry needling appears promising for providing short-term pain relief and enhancing movement. ^{2 4 5 6 7}

Who Is on the Research Team?

Kang Kim, PhD

Principal Investigator

University of Pittsburgh

Ajay Wasan, MD, MSc

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Adults with chronic low back pain due to muscle issues (Myofascial Pain) are eligible for this trial. The study is designed to understand if a test called the NUN biomarker can reflect changes in pain after treatment and predict who will respond best.

Inclusion Criteria

My lower back pain is classified as mild to moderate.

My lower back pain mainly affects my spine and has a muscle pain component.

I have sought medical help for lower back pain before.

Exclusion Criteria

Not able to complete the questionnaire

Currently pregnant or have intentions to become pregnant during the study

Active workers' compensation or litigation claims

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either real or sham dry needling in a single-blinded setup, with ultrasound imaging and pressure pain tests conducted before and after treatment

1 week

2 visits (in-person)

Follow-up

Participants are monitored for changes in pain levels and biomarker levels after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dry Needling
• NUN Biomarker
• Sham Dry Needling

Trial Overview The clinical trial tests whether the NUN biomarker levels correlate with improvements in myofascial pain following dry needling therapy. It also examines if sham dry needling, which is not real, has any effect compared to actual dry needling.

How Is the Trial Designed?

Group I: Dry needling Active Control 2 Interventions

Group II: Sham Dry Needling Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Ajay Wasan, MD, Msc

Lead Sponsor

Trials

3

Recruited

370+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36399082/

Efficacy of Dry Needling for Chronic Low Back Pain Results: A total of 8 RCTs involving 414 patients were included in the meta-analysis. All trials examined the efficacy of DN in patients with chronic LBP.

2. nature.com nature.com/articles/s41598-022-19980-1

The effectiveness of dry needling in patients with chronic ... This study aimed to assess the effectiveness of the novel DN program for reducing pain intensity and improving functional efficiency in patients with chronic ...

3. sciety.org sciety.org/articles/activity/10.21203/rs.3.rs-5855251/v1

Effectiveness of Dry Needling for Chronic Low Back Pain - Sciety Subgroup analyses indicated DN combined with physical therapy yielded better functional outcomes than DN alone. While DN shows promise for short ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000204568

Treating Myofascial Pain with Dry Needling: A Systematic ... Conclusions: Dry needling is an effective procedure for the treatment of myofascial pain in patients with acute and chronic low back pain.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05214456

The Effect of Dry Needling Compared to Lumbar Spine ... The main objective of this study is to compare the effects of dry needling and lumbar spinal mobilization on pain intensity, functional disability, lumbar ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7015026/

ADVERSE EVENTS ASSOCIATED WITH THERAPEUTIC ... Brady et al surveyed 39 physical therapists over a nine-month period and recorded all of the adverse events that occurred during dry needling treatment sessions ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423001163

Physiotherapy combined with dry needling among patients ... A clinical trial revealed that the application of dry needling in conjunction with physiotherapy resulted in notable enhancements in pain reduction, range of ...