Acute Lower Back Pain
Conditions
Keywords
chiropractic care, acute low back pain, mechanical
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
Interventions
OTHERChiropractic Care
Chiropractic Care is the active comparator arm / intervention. All subjects will receive chiropractic care.
OTHERRadial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse Therapy
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.
Sponsors
Northeast College of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Statistician
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity: Numeric Pain Rating Scale (NPRS) | From enrollment to the end of intervention at week 5. | 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 |
| Physical Function Assessment of a Squat Test | From enrollment to the end of intervention at week 5. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Biomechanics of Squat Performance | From enrollment to the end of intervention at week 5. | (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. |
Countries
United States
Contacts
Primary ContactRebecca Bauer, DC
Backup ContactJeanmarie R Burke, PhD
Outcome results
None listed