In patients with low back pain who received limited or no chiropractic care, orthoses had little effect on pain and disability, according to recent study results.
“The purpose behind the study was to see if orthotics could extend the effectiveness of a chiropractic manipulation, which I had seen anecdotally with foot taping, and wanted to formalize in a randomized clinical trial,” Anthony L. Rosner, PhD, research director, International College of Applied Kinesiology, Shawnee Mission, Kan., told O&P Business News.
Conducted in the Logan College of Chiropractic research laboratory, the double-blinded study followed 38 patients, aged 24 years to 74 years, who had experienced at least a month of lower back pain and had not worn orthoses within the past year.
Participants were split into two cohorts and studied over 4 weeks, including five in-person chiropractic visits. The first group was fitted with custom orthoses, and the second group was given flat insoles, or shams, which offered no corrective configurations.
Post-chiropractic care, both the custom and sham orthotic groups reported a reduction in pain and discomfort, but the study failed to show any significant variations between the two groups, Rosner said.
“Both groups said the trial improved [physical discomfort], but the difference was not statistically or clinically significant,” he said. “The orthotics did not effectively extend the pain and disability scales that we measured for the manipulations that were administered.”
The treating chiropractor tested the gluteus maximus, popliteus, lower trapezius, middle deltoid and neck extensor muscles of each patient, and administered high-velocity, low-aptitude (HVLA) manipulations for spinal fixations.
Testing also measured the number of weak muscles and number of spinal fixations in each patient, and administered the Roland-Morris disability index (RMS) to report lower back pain and disability, and the Quadruple Numerical Pain Rating Scale (NRS), which measures back pain according to four varying intensity scores.
Results showed improvement in each group for the NRS, RMS and decreased number of weak muscles. However, immediately after treatment, more than 75% of the decreases had been reversed.
“When the patients came back a few days later after the second, third and fourth visits, the number of weak muscles, number of fixations returned to almost the original value,” Rosner said.
While each group experienced this trend, differences between them were not significant, thus the clinical effectiveness of the orthotic devices could not be definitively demonstrated.
Rosner said the sham device, which was fabricated with a number of ridges, depressions and degree of cushioning, may have led to unintentional correction and caused limited variation. Two dimensional assessment may have also been a factor in insufficient customization of the orthoses. Other limitations included patient tolerance for daily orthosis wear and accurate self-assessment of patient pain.
Rosner said although the study provided key insights to lower back pain in patients and the orthotic correlation, there were a few caveats that should be considered for future studies.
“I am very interested to conduct a sequel to the trial with measurements of the duration and magnitude of load-bearing in each of the experimental groups, a more custom fitted orthotic device, and treatment periods that extend for longer than 1 month,” he said.
Since the initial study, the researchers have paired with a research facility and are looking for funding to proceed with further research. A method to determine how much time subjects are using the devices, a more sensitive NRS scale and a way to prolong beneficial effects of the orthoses will be explored. — by Shawn M. Carter
Disclosure: Rosner is a research director with the International College of Applied Kinesiology–USA and a consultant for Associated New Jersey Chiropractors.