Clinical trial NCT06852898: Comparative Clinical Trial: Manual Therapy With and Without Radial Extracorporeal Shockwave Therapy to Treat Acute Low Back Pain
Official title: Manual Therapy With Radial Extracorporeal Shockwave Therapy (ESWT) Compared to Manual Therapy Alone for the Treatment of Acute Mechanical Low Back Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Lower Back Pain
Keywords: chiropractic care
acute low back pain, mechanical
Lead sponsor: Northeast College of Health Sciences
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Biological sex of male or female
2. Age Range: 18 to 40 years old
3. Diagnosis of acute mechanical low back pain (\< 3 months duration)
4. 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"

Exclusion Criteria:

1. 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.
2. Subjects who used oral corticosteroids that are only available by prescription to manage any medical condition within the past 6 weeks.
3. Subject who received a corticosteroid injection for any medical condition within the past 6 weeks.
4. Subjects who are not willing to be randomly assigned to either of the treatment interventions.
5. Subjects with open wounds to the lower and mid back that will prevent the application of radial ESWT.
6. Subjects with hypermobility and/or instability of the lower and mid back, which are contraindications for manual therapy.
7. Subjects who have a case history of low back pain episodes, e.g., chronic or persistent occurrence of low back pain.
8. 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.

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Primary outcomes:
measure: Pain Intensity: Numeric Pain Rating Scale (NPRS)
timeFrame: From enrollment to the end of intervention at week 5.
measure: Physical Function Assessment of a Squat Test
timeFrame: From enrollment to the end of intervention at week 5.
Secondary outcomes:
measure: Clinical Biomechanics of Squat Performance
timeFrame: From enrollment to the end of intervention at week 5.
Other outcomes:
Locations:
city: Seneca Falls
country: United States
facility: Seneca Falls Health Center at Northeast College of Health Sciences
state: New York
Study officials:
References: