Chiropractic Care + Radial Pulse Therapy for Low Back Pain

Overseen By Jeanmarie R Burke, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northeast College of Health Sciences

Must not be taking: NSAIDs, Corticosteroids

Disqualifiers: Open wounds, Hypermobility, Chronic pain, others

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

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if the addition of radial pulse therapy to chiropractic care will help adult patients recover faster to an acute bout of low back pain. Radial pulse therapy is the application of acoustic waves that passes through the skin to tissues and cells in the body. The main questions that the clinical trial aims to answer are: * Does the addition of radial pulse therapy to chiropractic care result in better or earlier reduction in pain intensity? * Does the addition of radial pulse therapy to chiropractic care result in better or earlier improvement in physical function? Researchers will compare radial pulse therapy plus chiropractic care to chiropractic care alone to see if patients with acute low back pain recover faster with the addition of radial pulse therapy. Participants will: * Visit the clinic once a week for 5 weeks * Receive chiropractic care with or without the addition of radial pulse therapy to the low back and hip regions of the body * Report their pain intensity and perform a physical function test at each clinic visit

Will I have to stop taking my current medications?

If you are currently using over-the-counter or prescription NSAIDs (like ibuprofen or naproxen) or have used oral corticosteroids in the past 6 weeks, you cannot participate in this trial. The protocol does not specify other medication restrictions.

What data supports the effectiveness of the treatment Radial Extracorporeal Shockwave Therapy for low back pain?

Research shows that Radial Extracorporeal Shockwave Therapy (rESWT) can significantly reduce pain and improve movement and posture in people with chronic low back pain, especially when combined with exercises for core stability. ^{1 2 3 4 5}

Is Radial Extracorporeal Shockwave Therapy (rESWT) safe for humans?

Research on Radial Extracorporeal Shockwave Therapy (rESWT) for low back pain suggests it is generally safe for humans, with studies focusing on its effectiveness and safety for conditions like chronic low back pain and knee osteoarthritis. ^{1 2 3 4 6}

How does Chiropractic Care + Radial Pulse Therapy differ from other treatments for low back pain?

This treatment combines chiropractic care with radial pulse therapy, which is a form of shockwave therapy that uses lower pressure waves to target pain and improve function. Unlike standard treatments, this approach may offer enhanced pain relief and functional improvement by addressing both spinal alignment and soft tissue conditions. ^{1 2 3 4 7}

Eligibility Criteria

Adults with acute low back pain can join this trial. They should be able to visit the clinic weekly for 5 weeks and report their pain levels. People who have conditions that might interfere with the treatment or assessments are likely excluded, but specific exclusion criteria are not provided.

Inclusion Criteria

I identify as either male or female.

I have had lower back pain for less than 3 months.

My pain level has been over 3 out of 10 recently.

Exclusion Criteria

I have a very flexible or unstable lower and mid back.

I am currently taking NSAIDs like ibuprofen or naproxen.

I have used prescription oral corticosteroids in the last 6 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chiropractic care with or without radial pulse therapy once a week for 5 weeks

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Radial Extracorporeal Shockwave Therapy

Trial Overview The study is testing if adding radial pulse therapy (acoustic waves treatment) to regular chiropractic care helps patients with acute low back pain recover faster. It compares outcomes of pain reduction and physical function improvement between those receiving both treatments versus just chiropractic care.

Participant Groups

Group I: Chiropractic Care Plus Radial Pulse Therapy Experimental Treatment 2 Interventions

Chiropractic Care is the same as described for the active comparator arm. After receiving chiropractic care, the subject receives radial extracorporeal shockwave therapy (ESWT). The treating clinician places the ESWT probe over the treatment areas in the mid back, low back, and hip regions. At each clinic visit, there are up to six treatment areas for ESWT. At each treatment area, the subject receives 2000 radial pulses at frequency of 10 Hz (single pulse every 100 ms or 10 pulses per second). The intensity of the radial pulses are comfortable for the subjects. Duration of ESWT at each treatment area is 200 seconds or 3.33 minutes.

Group II: Chiropractic Care Only Active Control 1 Intervention

1. The treating clinician will use soft tissue palpation procedures applied to hips, pelvis / buttocks low back and mid back to identify taut and tender regions for manual therapy, e.g., trigger points that the clinician identified during soft tissue palpations. 2. The treating clinician will use soft tissue treatment procedures, e.g., applying precise pressure to trigger points and manual stretching techniques, to relieve taut and tender regions that were identified during soft tissue palpation procedures. 3. The treating clinician will perform high velocity, low amplitude (HVLA) spinal adjustments to restricted areas of the mid back, lower back, and hips regions.

Who Is Running the Clinical Trial?

Northeast College of Health Sciences

Lead Sponsor

Trials

4

Recruited

160+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

The Effectiveness Of Radial Extracorporeal Shock Wave Therapy In Patients With Chronic Low Back Pain: A Prospective, Randomized, Single-Blinded Pilot Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of treating chronic nonspecific low back pain with radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C + E) or C + E alone: a prospective, randomized trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Radial Extracorporeal Shock Wave Therapy on Pain Intensity, Functional Efficiency, and Postural Control Parameters in Patients with Chronic Low Back Pain: A Randomized Clinical Trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Extracorporeal Shockwave Therapy for Treating Chronic Low Back Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]

5. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness of conventional physical therapy and extracorporeal shock wave therapy on pain, disability, functional status, and depression in patients with chronic low back pain. [2022]

6. Sweden pubmed.ncbi.nlm.nih.gov

Dose-related effects of radial extracorporeal shock wave therapy for knee osteoarthritis: A randomized controlled trial. [2022]

7. China pubmed.ncbi.nlm.nih.gov

Radial wave therapy does not improve early recovery of erectile function after nerve-sparing radical prostatectomy: a prospective trial. [2023]