In patients with nonspecific subacute or chronic low back pain, standard osteopathic manipulative treatment demonstrated a small, positive effect on pain-specific activity limitations, but the clinical relevance of this effect is, according to researchers, still questionable. This is according to research results published in JAMA Internal Medicine.
In a prospective, parallel-group, single-blind, single-center, sham-controlled, randomized clinical trial (ClinicalTrials.gov identifier NCT02034864), researchers sought to compare the efficacy of standard osteopathic manipulative treatment with sham osteopathic manipulative treatment to reduce low back pain-specific activity limitations.
The primary study endpoint was the mean reduction in low back pain-specific activity limitations at 3 months, measured via the self-administered Quebec Back Pain Disability Index Score (QBPDI). Secondary outcomes included the mean reduction in low back pain-specific activity limitations, mean changes in both pain and health-related quality of life, the number and duration of sick leaves, the number of low back pain episodes at 12 months, and the consumption of analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs) at 3 and 12 months.
In total, 400 participants were randomly assigned 1:1 to receive either standard or sham osteopathic manipulative treatment. After exclusion criteria, there were 197 patients in each group; 9.3% of patients did not receive the intervention.
Median age at inclusion was 49.8 years (range, 40.7-55.8 years); 59.6% of participants were women and 91.3% were currently working. Mean duration of the current low back pain episode was 7.5(±14.2) months with a pain score of 41.7(±21.3) and a QBPDI score of 29.3(±14.6). In total, 79.7% of participants in the standard treatment group and 68% in the sham treatment group received 6 sessions.
Primary endpoint data at 3 months were available for 83.2% and 80.7% of patients in the standard and sham treatment groups. All 394 participants had at least 1 baseline or postrandomization measurement available to compute treatment effect differences.
In the standard treatment group, mean QBPDI scores were 31.5(±14.1) at baseline and 25.3(±15.3) at month 3; in the sham treatment group, scores were 27.2(±14.8) and 26.1(±15.1) at baseline and 3 months, respectively. At 3 months, mean reduction in low back pain-specific activity limitations was -4.7 (95% CI, -6.6 to -2.8) and -1.3 (95% CI, -3-3 to 0.6), respectively (mean difference in favor of standard treatment, -3.4; 95% CI, -6.0 to -0.7; P =.01).
At month 12, mean reduction in low back pain-specific activity limitations was -5.6 and -1.3 in the standard and sham treatment groups, respectively (mean difference in favor of standard treatment, -4.3; 95% CI, -7.6 to -0.1; P =.01). At months 3 and 12, mean difference in pain reduction was -1.0 and -2.0, respectively. No differences in mean improvement in health-related quality of life or NSAID use at 3 and 12 months were noted, nor were differences seen in the self-reported number and duration of sick leaves or low back pain episodes at 12 months.
At month 12, 50.3% and 47.2% of participants in the standard and sham treatment groups reported at least 1 adverse event, 12 of which were serious adverse events (4 in the standard treatment group and 8 in the sham treatment group).
Study limitations included the focus on standard osteopathic manipulative treatment, missing data from patients, and a large loss to follow-up that may have impacted outcomes at 3 and 12 months.
“[I]n nonspecific subacute or chronic [low back pain], standard…vs sham [osteopathic manipulative treatment] had a small effect on low back pain-specific activity limitations. However, this effect was likely not clinically meaningful,” the researchers concluded. “These results raise the issue of the usefulness of [osteopathic manipulative treatment] in people with nonspecific subacute and chronic [low back pain].”
Nguyen C, Boutron I, Zegarra-Parodi R, et al. Effect of osteopathic manipulative treatment vs sham treatment on activity limitations in patients with nonspecific subacute and chronic low back pain: A randomized clinical trial. Published online March 15, 2021. JAMA Intern Med. doi: 10.1001/jamainternmed.2021.0005