Dry Needling for Chronic Low Back Pain

Overseen By Joel Bialosky, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Blood thinners

Disqualifiers: Non-English, Surgery, Bleeding disorders, others

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

Compensation: Varies

Number of Visits: 7

Duration: Approximately 2 weeks

71 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how dry needling, a technique using small needles inserted into muscles, can relieve chronic low back pain. The researchers aim to understand what makes dry needling effective to personalize and improve future treatments. Participants will receive dry needling in some sessions and complete surveys about how pain affects their lives. Individuals who have experienced low back pain for at least three months and feel it most days might be suitable for this study.

As an unphased study, this trial offers a unique opportunity to contribute to advancements in personalized treatment for chronic low back pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using medications that cause difficulty with clotting, like blood thinners.

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

Research has shown that dry needling is generally well-tolerated by patients. In one survey, 39 physical therapists reported side effects during dry needling sessions over nine months. Most side effects were minor, such as temporary soreness or bruising, and serious problems were rare. Another study found that dry needling helped reduce pain and improve movement in people with long-term low back pain. This suggests that while some mild discomfort might occur, the treatment is considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Dry needling is unique because it directly targets trigger points in the muscles, which are often the source of chronic low back pain. Unlike standard treatments like medication or physical therapy, dry needling involves inserting thin needles into the muscle to release tension and improve blood flow, potentially offering quicker relief. Researchers are excited about this technique because it provides a more direct approach to alleviating pain and may reduce the need for long-term medication use, which can have side effects. Additionally, the method is minimally invasive and sessions are relatively short, making it a convenient option for patients.

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

Research has shown that dry needling, which participants in this trial will receive, can help treat long-lasting low back pain. A review of eight studies involving 414 patients found that dry needling relieves pain. Another study found that it lowers pain levels and improves movement and daily activities. Using dry needling along with physical therapy seems to yield even better results. Overall, dry needling appears promising for managing chronic low back pain, especially when combined with other treatments. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have been experiencing chronic low back pain for at least three months. It's designed to understand how dry needling can help relieve this type of pain and improve quality of life.

Inclusion Criteria

I am experiencing lower back pain that may or may not spread to my legs.

I have had low back pain almost every day for the last 3 months.

I am not currently undergoing treatment for my low back.

Exclusion Criteria

Non-English speaker

Presence of a medical condition known to affect sensation

Contraindication to the application of needles including, but not limited to, diabetes, local infection, epilepsy, fear of needles or metal allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete baseline assessments including questionnaires and physical tests

1 session

1 visit (in-person)

Treatment

Participants receive dry needling treatment and complete related assessments

Approximately 2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dry Needling

Trial Overview

The study tests the effectiveness of dry needling, a technique where needles are inserted into muscle tissue to alleviate chronic low back pain. Participants will attend five sessions, receive dry needling in three, and complete online surveys.

How Is the Trial Designed?

Group I: Dry needling Experimental Treatment 1 Intervention

The participant will be placed prone. The skin on each side of the spine at the level of the identified trigger point will be prepped and cleaned with an alcohol swab. Four 50mm - 60 mm filiform needles will be used to penetrate the skin in the lower back; two needles will be inserted bilaterally on each side of the spine at the level of the trigger point. Needles will be placed approximately 1.5cm lateral to the spinous process, directed at a 20 to 30-degree inferior medial angle into the lumbar multifidus. Needles will be manipulated with an "in and out" pistoning technique for 5 - 10 seconds when first inserted into the muscle. After 5 -10 second , the needles will be left resting in the muscle for 10 minutes. Participants will receive 3 sessions of dry needling. Each session will be approximately 72-96 hours apart.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

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.

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.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06179-y

Electrical dry needling versus conventional physiotherapy in ...

We believe that an approach including electrical dry needling to chronic low back pain dysfunction will be more effective in these patients.

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 ...

8.

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 ...