Table 1.
Trial demographics
| Characteristic | Total Sample N= 107 (100) |
Pharmacologic N= 54 (50) |
Non-pharmacologic N= 53 (50) |
|---|---|---|---|
| Article, N (% of column) or Median [IQR] | |||
| Type of pain | |||
| Headache/migraine | 60 (56) | 40 (74) | 20 (38) |
| Abdominal/IBS | 24 (22) | 10 (19) | 14 (26) |
| Arthritis | 9 (8) | 1 (2) | 8 (15) |
| Musculoskeletal | 7 (7) | 0 (0) | 7 (13) |
| Fibromyalgia | 5 (5) | 2 (4) | 3 (6) |
| CRPS | 2 (2) | 1 (2) | 1 (2) |
| Trial design | |||
| Parallel | 93 (87) | 41 (76) | 52 (98) |
| Cross-over | 14 (13) | 13 (24) | 1 (2) |
| Sample size* | 63 [36–118] | 100 [42–155] | 50 [36–77] |
| Type of comparison group | |||
| Placebo | 49 (46) | 40 (74) | 9 (17) |
| Two treatments compared | 17 (16) | 10 (19) | 7 (13) |
| Wait list | 10 (9) | 0 (0) | 10 (19) |
| Standard of care (defined by the protocol) | 8 (7) | 0 (0) | 8 (15) |
| Education | 8 (7) | 0 (0) | 8 (15) |
| Standard of care (preference of the treating physician – not standardized) | 5 (5) | 0 (0) | 5 (9) |
| Active control | 4 (4) | 2 (4) | 2 (4) |
| Other (e.g., two different frequencies of sessions of physical therapy) | 6 (6) | 2 (4) | 4 (8) |
| Sponsor | |||
| Industry | 21 (20) | 20 (37) | 1 (2) |
| Not industry (e.g., government or professional organization) | 53 (50) | 14 (26) | 39 (74) |
| No external funding | 5 (5) | 3 (6) | 2 (4) |
| Not reported | 28 (26) | 17 (31) | 11 (21) |
| Study blinding | |||
| Double | 48 (45) | 46 (85) | 2 (4) |
| Assessor only blinded | 18 (17) | 1 (2) | 17 (32) |
| Unclear for assessor (patient could not be blinded) | 12 (11) | 0 (0) | 12 (23) |
| Unclear | 10 (9) | 3 (6) | 7 (13) |
| None | 10 (9) | 2 (4) | 8 (15) |
| Patient blinded | 2 (2) | 1 (2) | 1 (2) |
| Patient and assessor blinded | 2 (2) | 0 (0) | 2 (4) |
| Other | 5 (5) | 1 (2) | 4 (8) |
| Site characteristics | |||
| Single site | 53 (50) | 23 (43) | 30 (57) |
| Multi-site | 47 (44) | 30 (56) | 17 (32) |
| # sites unclear | 7 (7) | 1 (2) | 6 (11) |
| Duration of study follow-up | |||
| <2 months | 20 (19) | 18 (33) | 2 (4) |
| 2–6 months | 47 (44) | 23 (43) | 24 (45) |
| >6 months | 34 (32) | 7 (13) | 27 (51) |
| Unclear | 6 (6) | 6 (11) | 0 (0) |
IBS= Irritable Bowel Syndrome, CRPS= Complex Regional Pain Syndrome, TENS =Transcutaneous Electric Stimulation