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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiropractic Care Only | Active Comparator |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic Care | Other | Chiropractic Care is the active comparator arm / intervention. All subjects will receive chiropractic care. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| From enrollment to the end of intervention at week 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Biomechanics of Squat Performance | (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 secondary outcomes from Clinical Biomechanics Report are: (1) Thighs Reached Horizontal; (2) Knee Valgus; (3) Knee Over Toe; (4) Heels Raised; (5) Shoulder-Wrist Line; (6) Shoulder Lateral Tilt; (7) Shoulder Axis Rotation; and (8) Lumbopelvic Rounding. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seneca Falls Health Center at Northeast College of Health Sciences | Seneca Falls | New York | 13148 | United States |
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Statistician
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| 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. |
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| From enrollment to the end of intervention at week 5. |