| PMC full text: | Published online 2019 Mar 5. doi: 10.1136/bmj.l689
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Table 2
Summary of adverse event assessments among trials included in systematic review of spinal manipulative therapy (SMT) for chronic low back pain
| Study, sample size | Methods used to assess adverse events | Adverse events assessed | Adverse events reported (for SMT or control group) |
|---|---|---|---|
| Balthazard 2012, n=42 | Not reported | Any adverse event | No adverse events reported; but one patient dropped out in each group owing to severe pain |
| Bronfort 2011, n=301 | Self reported throughout follow-up | Any adverse event | “All adverse events were transient in nature, required little or no change to activity levels, and were considered non-serious,” 6 (2%) patients were treated with rescue pain medication during treatment period: severe back pain, acute flare-up of low back and buttock pain, neck pain, and inability to sleep because of pain. Four (1%) patients reported similar adverse events but declined rescue medication |
| Brønfort 1996, n=174 | Not reported | Any adverse event | Non-steroidal anti-inflammatory drug group: 2 (4%) patients developed severe nausea and vomiting and subsequently discontinued the study, 8 (16%) developed substantial nausea and dyspepsia, and 1 (2%) developed severe tinnitus; SMT+exercise groups: 1 (2%) patient discontinued exercise because she did not tolerate it well and 7 (14%) developed muscle soreness and stiffness, including neck pain after exercise—these symptoms gradually abated and did not prevent completion of the study; 1 (1%) developed symptoms of a myocardial infarction unrelated to exercise. “Overall, both strengthening and stretching exercise and SMT were well tolerated” |
| Castro-Sanchez 2016, n=62 | Self reported after treatment and follow-up | Any adverse event | No adverse events reported |
| Cecchi 2010, n=210 | Not reported | Any adverse event | No adverse events reported |
| Cook 2013, n=154 | Physiotherapists queried at end of study | Any adverse event | No adverse events reported |
| Dougherty 2014a, n=181 | Assessed at each treatment visit and via phone calls during follow-up period | Any adverse event | 243 adverse events were reported during the study: 55% in exercise group and 45% in SMT group. Of 110 events reported in the SMT group, the Data Safety Monitoring Board (DSMB) judged 14 as definitely or probably associated with SMT. Most adverse events consisted of musculoskeletal soreness and resolved within study period. During the study period, 10 serious adverse events were reported (5 control group, 5 SMT group); DSMB judged none of the serious adverse events to be associated with the study intervention |
| Evans 1978, n=36 | Not reported | Any adverse event | 1 (3%) patient reported constipation after consumption of 24 codeine phosphate capsules in first 4 days; no serious adverse events reported |
| Ferreira 2007, n=240 | Not reported | Any adverse event | No adverse events reported, one patient died, and one was admitted to hospital, in control group |
| Gudavalli 2006, n=235 | Not reported | Any adverse event | No adverse events reported |
| Haas 2014, n=400 | Not reported | Any adverse event | 3 (1%) patients reported seeking care for symptomatic relief of low back pain exacerbation related to study, 1 (1%) lost several days of work followed by complete resolution during treatment phase, and 1 (1%) dropped out after an exacerbation associated with lifting a child; no serious adverse events reported |
| Hidalgo 2015, n=32 | Not reported | Any adverse event | No serious or moderate adverse events reported |
| Hondras 2009, n=240 | Not reported | Any adverse event | 20 (8%) patients reported an adverse event, all resolved within 6 days, and none required referral for outside care. Adverse events in SMT groups consisted of soreness or stiffness. 1 patient reported a skin rash in drug group; no serious adverse events reported |
| Hsieh 2002, n=206 | Not reported | Any adverse event | 23 (12%) patients reported adverse events: 17 (11%) in control groups (combined), 6 (12%) in SMT group; adverse events were limited to transient exacerbations of symptoms, except for one case of constant tinnitus in a control group; 2 (4%) patients claimed SMT had aggravated their condition; no serious adverse events reported |
| Licciardone 2013, n=455 | Not reported | Any adverse event | 27 (6%) patients reported an adverse event; 9 (2%) reported a serious adverse event (“none was definitely or probably related to a study intervention” according to DSMB); no significant differences between groups in frequency of (serious) adverse events; 6 patients who received SMT developed a contraindication to continued study participation (SMT was adjudicated by DSMB to be possibly related to development in only one of these) |
| Muller 2005, n=115 | Not reported | Any adverse event | 3 (6%) patients in drug group experienced an adverse event; no serious adverse events reported |
| Rasmussen 2008, n=72 | Not reported | Any adverse event | 4 (11%) patients in SMT group reported worsening of low back pain versus 3 (8%) in control group; no serious adverse events reported |
| Senna 2011, n=93 | Not reported | Any adverse event | Most common were local discomfort and tiredness, which were transient and began within 24 hours after treatment, and were of mild to moderate severity; no serious adverse events reported |
| Skillgate 2007, n=409 | Self-reported events at a follow-up visit | Any adverse event | Minor short term events limited to muscle soreness, tiredness, and increased pain, most commonly after first and second treatments; no serious adverse events reported |
| UK BEAM trial 2004, n=1334 | Monitoring by research team; not elucidated further | Serious adverse events only, defined as admission to hospital or death within one week of treatment | No serious adverse events reported |
| Walker 2013, n=183 | Self-reported events at each follow-up visit | Any adverse event | 30 (33%) of patients in sham group and 39 (42%) in SMT group reported at least 1 adverse event; common adverse events were increased pain (sham 29%; SMT 36%), muscle stiffness (sham 29%; SMT 37%), and headache (sham 17%; SMT 9%). The relative risk was not significant for adverse event occurrence (1.24, 95% confidence interval 0.85 to 1.81), occurrence of severe adverse events (1.9, 0.98 to 3.99), adverse event onset (0.16, 0.02 to 1.34), or duration of adverse events (1.13, 0.59 to 2.18); no serious adverse events reported |
| Xia 2016, n=192 | Not reported | Not reported | No serious adverse events reported |
| Zaproudina 2009, n=131 | Not reported | Not reported | 1 (2%) patient in SMT group and 2 (3%) in control group discontinued treatment owing to worsening of low back pain; no serious adverse events reported |