71 Participants Needed

Dry Needling for Chronic Low Back Pain

LR
JB
Overseen ByJoel Bialosky, PT, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Dry Needling for Chronic Low Back Pain?

Research shows that dry needling can be effective for chronic low back pain, as several studies and reviews have found it helps reduce pain and improve function in patients.12345

Is dry needling safe for humans?

Dry needling is generally well tolerated, but there are some risks. Most side effects are minor, but serious complications like pneumothorax (collapsed lung) and spinal epidural hematoma (bleeding around the spinal cord) have been reported. It's important for practitioners to follow safety guidelines to minimize these risks.14678

How is the treatment dry needling different from other treatments for chronic low back pain?

Dry needling is unique because it involves inserting thin needles into specific muscle areas called myofascial trigger points to relieve pain, unlike other treatments that may use medication or physical therapy. This approach targets the source of pain directly and is considered a minimally invasive option.12349

What is the purpose of this trial?

Low back pain is a common problem that many adults experience at some point in their lives. One treatment being studied is dry needling, a technique where a small needle is inserted into a specific area of muscle to help relieve pain. So far, the research on dry needling for low back pain hasn't been clear, and it's hard to know when and for whom it will work best. This study aims to figure out how dry needling works to help people with chronic low back pain by looking at the underlying factors. By understanding how dry needling helps people, we can develop a more targeted approach to treatment, which could lead to better outcomes for people with chronic low back pain. The goal of this study is to identify the factors that make dry needling effective for people with chronic low back pain, so that this this information can be used to provide more personalized and effective care.Eligible participants will attend 5 research sessions lasting approximately 1 hour and complete 2 online surveys. At 3 of those sessions, participants will receive dry needling to their low back.As part of the research, participants will complete questionnaires related to how pain effects their life. Participants will also undergo testing for muscle stiffness, low back mobility and strength, and pain sensitivity.To be included in this study participants must:* Be 18-65 years of age* Have low back pain for at least 3 months

Eligibility Criteria

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
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Timeline

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Dry needlingExperimental Treatment1 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.

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Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Findings from Research

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

References

Efficacy of Dry Needling for Chronic Low Back Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]
[Non-medical therapy of myofascial pain]. [2018]
Electrical dry needling versus a non-invasive multicomponent intervention in the treatment of myofascial trigger points in patients with chronic low back pain: A randomised clinical trial. [2023]
Is dry needling effective for low back pain?: A systematic review and PRISMA-compliant meta-analysis. [2023]
Systematic Review to Inform a World Health Organization (WHO) Clinical Practice Guideline: Benefits and Harms of Needling Therapies for Chronic Primary Low Back Pain in Adults. [2023]
Prediction model of rhomboid major and pleura depth based on anthropometric features to decrease the risk of pneumothorax during dry needling. [2021]
Acute Spinal Epidural Hematoma as a Complication of Dry Needling: A Case Report. [2020]
Identifying which adverse events associated with dry needling should be included for informed consent: A modified e-Delphi study. [2023]
Evidence for Dry Needling in the Management of Myofascial Trigger Points Associated With Low Back Pain: A Systematic Review and Meta-Analysis. [2022]
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