| Intervention | Reported Adverse Events |
|---|---|
| Exercise vs. usual care, waitlist, no treatment, attention control, sham treatment, acetaminophen, standard analgesics and anti-inflammatory therapy. | No statistical differences between exercise and any comparator were identified for any condition. One RCT in older patients with knee OA pain reported six SAEs; five were in the exercise group [4 falls (1 resulting in distal radius fracture); 1 foot fracture from dropping a dumbbell]. Sudden death was reported in one attention control participant. No other intervention-related SAEs requiring medical intervention were reported across trials of exercise for LBP, neck pain, OA pain or FM. Reported AEs included minor and/or temporary increases in pain with exercise ranging from 3% to 22% versus 0% to 3% for comparators. Withdrawal for worsening pain ranged between 3% and 10% compared with 0% in usual care or no treatment groups. |
| Psychological therapies vs. usual care, waitlist, no treatment, attention control, exercise | No intervention-related SAEs requiring medical intervention were reported for psychological therapies vs. usual care, waitlist or attention control for LBP, knee OA pain, or CTTH. Harms were not reported in neck pain trials. Withdrawal due to an AE (claim that physiotherapist hurt participant or participant did not benefit) was similar for psychological therapies versus usual care (0.2% vs. 0.4%, 1 in each group) in one LBP trial. For CTTH, withdrawal and risk of intervention-related AEs (not specified) was 2% in one small trial. For FM, AEs were more commonly reported in control groups (attention control, waitlist, usual care, pregabalin with duloxetine and exercise). Intervention-specific withdrawal due to depression (2 patients) was reported in one trial; another reported brief, occasional exacerbation of symptoms (pain, sleep problems). Most trials reported that there were no AEs. |
Ultrasound vs. sham ultrasound Interferential therapy vs. sham | For LBP, risk of SAEs (not defined, not considered to be intervention related) was similar for ultrasound and sham [3 patients (1.3%) vs. 6 patients (2.7%), respectively] as was risk of any AE (6.0% vs. 5.9%) in one trial. No AEs were identified across trials in knee OA pain. In one trial of interferential therapy, withdrawal due to any AE (not defined) was similar (4% in each group). |
| Low-level laser therapy vs. sham or exercise | No AEs were reported vs. sham or exercise in LBP patients or vs. sham in knee OA patients. Erythema was experienced by one patient with hand OA. In patients with neck pain, in one trial, AEs in the intervention group included mild (78%) or moderate (60%) increased neck pain, increased pain elsewhere (78%), mild headache (60%) and tiredness (24%). |
| Diathermy vs. sham Electromagnetic field vs. sham | For knee OA, two cases of transient symptom aggravation with microwave diathermy were reported (1 RCT) and 24 patients reported throbbing sensation or warming sensations or aggravation of pain with electromagnetic field treatment (1 RCT). |
| Spinal manipulation vs. Usual care, attention control, placebo, exercise or pharmacological treatment | For LBP, no SAEs or withdrawal due to AEs (not defined) were observed (10 RCTs); primary nonserious AEs reported included mild to moderate increase in pain, local discomfort and tiredness (2 RCTs). For CTTH, temporary neck stiffness occurred; 1.4% of patients withdrew from the manipulation group vs. 8.9% from the amitriptyline group in one trial. |
| Massage vs. sham, usual care, attention control, exercise | No serious intervention-related adverse events requiring medical intervention were reported with massage for LBP, neck pain, OA pain or FM. Nonserious AEs included discomfort, aching muscles, headache, and tenderness; reports of increased pain ranged from <1% to 26% for LBP. |
| MBSR vs. usual care | For LBP in one trial, 29% of MBSR patients reported temporarily increased pain. |
| Mindbody practices (yoga, tai chi, Qigong) vs. usual care, attention control, waitlist, exercise | For LBP, three SAEs were reported in one yoga patient each: cellulitis and a herniated disc in one RCT (0.8% for both, unclear if these were treatment-related) and severe back pain possibly or probably related to yoga in another RCT (1%). No trial of neck pain, knee OA pain or FM reported SAEs due to mindbody practices in their populations. Nonserious AEs reported across studies: for LBP, range 7% to 16% across four RCTs of yoga or Qigong, mostly related to increased back/joint pain, muscle soreness or dizziness; for neck pain, knee injury and muscle spasms (0.6%; one case each) in one RCT of Alexander Technique and an event risk of 0.27 in one RCT of body awareness therapy (primarily due to increased pain); for knee OA pain, mild muscle soreness and foot or knee pain was reported with tai chi in one RCT (no data provided); and for FM, mild to moderate treatment-related AEs occurred in 4% (tai chi) and 5% (Qigong) of patients in 2 RCTs; shoulder pain, plantar fasciitis were specified others were not. |
| Acupuncture vs. sham, usual care, attention control, placebo, pharmacological therapy | Treatment-related SAEs were rare (across 5 LBP, 5 neck pain, 4 FM, 1 knee OA, and 1 CTTH trial); only one event (needle insertion site pain lasting1 month) in a LBP patient (<1%) in one trial was considered related to treatment, SAEs not considered to be related to acupuncture or the study conditions (range 0% to 9% across 5 LBP, 5 neck pain, 4 FM, 1 knee OA, and 1 CTTH trial). These included hospitalization (primarily) or outpatient treatment; reasons were not specified. The most commonly reported nonserious AEs: swelling, bruising, bleeding or pain at the acupuncture site (1% to 61%, 12 RCTs; or 1% to 18% excluding an outlier trial)); numbness, discomfort, pain or increase in symptoms (1% to 14%; 11 RCTs), dizziness, nausea, fainting (1% to 7%, 7 RCTs), headache (1% to 2%; 4 RCTs), vasovagal symptoms (1% to 4%; 2 RCTs), respiratory problems, chest discomfort (1%; 2 neck pain RCTs), and infection at needle insertion site [1%; 1 RCT (knee OA)] |
| MDR vs. usual care, waitlist, exercise pharmacological therapy | No intervention-related SAEs requiring medical intervention were reported. Specified nonserious AEs included transient worsening of pain (3 patients) including one report of a painful swollen hand after a treatment session and mood alteration (2 patients). One trial reported that 19% of MDR recipients with FM withdrew with two patients attributing withdrawal to increased pain. |
From: Discussion
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