Comparative Clinical Trial: Manual Therapy With and Without Radial Extracorporeal Shockwave Therapy to Treat Acute Low Back Pain

NCT06852898 | Recruiting

• 1 other identifier: 24-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Lower Back Pain

Keywords

chiropractic care; acute low back pain, mechanical

Outcome Measures

Primary Outcomes (2)

• Pain Intensity: Numeric Pain Rating Scale (NPRS)

  Before the administration of treatment at each visit, subjects rate their pain on a scale of 0 to 10 with 0 being no pain at all and 10 being worse pain possible. The subjects provide NPRS scores within the context of right now, pain at its best in the past 7 days, and pain at its worst in the past 7 days. At the end of each treatment visit, subjects rate their pain right now on a scale of 0 to 10 with 0 being no pain at all and 10 being worse pain imaginable

  From enrollment to the end of intervention at week 5.

• Physical Function Assessment of a Squat Test

  1. Before and after the administration of treatment at each visit, subjects perform six squats - moving from a standing position to a squat position. Using an iPad Pro researchers record subjects performing the 3 consecutive squats from a front view and then 3 consecutive squats from a side view. There are 15 seconds between the six squats. 2. Using the Kinetisense software on the iPad Pro, researchers generate a Clinical Biomechanics Report to measure squat performance. 3. The overall score from clinical biomechanics report for the squat test is the primary outcome to assess physical function.

  From enrollment to the end of intervention at week 5.

Secondary Outcomes (1)

• Clinical Biomechanics of Squat Performance

  From enrollment to the end of intervention at week 5.

Study Arms (2)

Chiropractic Care Only

ACTIVE COMPARATOR

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.

Other: Chiropractic Care

Chiropractic Care Plus Radial Pulse Therapy

EXPERIMENTAL

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.

Other: Chiropractic Care; Other: Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse Therapy

Interventions

Chiropractic Care OTHER

Chiropractic Care is the active comparator arm / intervention. All subjects will receive chiropractic care.

Chiropractic Care Only; Chiropractic Care Plus Radial Pulse Therapy

Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse Therapy OTHER

This intervention is answering the question: Does on radial ESWT have additive therapeutic effects on the recovery of acute lower back pain symptoms - better or earlier reduction in pain intensity or improvement in physical function - than chiropractic care / manual therapy alone? Subjects will be randomly assigned to receive chiropractic care and ESWT or only chiropractic care.

Chiropractic Care Plus Radial Pulse Therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Biological sex of male or female
• Age Range: 18 to 40 years old
• Diagnosis of acute mechanical low back pain (\< 3 months duration)
• Pain intensity \> 3 on the 11 point NPRS with 0 "being no pain at all" to 10 "being worse pain possible" within the context of either "right now" or "at its worst during the past 7 days"

You may not qualify if:

• Subjects who are currently using over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen (Advil, Motrin) and naproxen (Aleve), or prescription NSAIDs to manage any medical condition.
• Subjects who used oral corticosteroids that are only available by prescription to manage any medical condition within the past 6 weeks.
• Subject who received a corticosteroid injection for any medical condition within the past 6 weeks.
• Subjects who are not willing to be randomly assigned to either of the treatment interventions.
• Subjects with open wounds to the lower and mid back that will prevent the application of radial ESWT.
• Subjects with hypermobility and/or instability of the lower and mid back, which are contraindications for manual therapy.
• Subjects who have a case history of low back pain episodes, e.g., chronic or persistent occurrence of low back pain.
• Subjects who do not meet the differential diagnosis of acute mechanical low back pain, i.e., origin of their back pain is unknown or non-specific to a low back structure.

Sponsors & Collaborators

• Northeast College of Health Sciences: lead

Study Sites (1)

Seneca Falls Health Center at Northeast College of Health Sciences

Seneca Falls, New York, 13148, United States

RECRUITING

Central Study Contacts

Rebecca Bauer, DC

CONTACT

1-315-568-3166; rbauer@northeastcollege.edu

Jeanmarie R Burke, PhD

CONTACT

315 568-3869; jburke@northeastcollege.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Faculty and Research

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 28, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)