Background
Methods
Study design
Participants and settings
Randomization and blinding
Interventions
Outcome measures
Primary outcomes
Secondary outcomes
Feasibilty criteria
Adverse events
Sample size
Statistical analyses
Results
Feasibility: Recruitment, retention and treatment visits
Baseline characteristics
Characteristic | Shared Care, n = 44 | Dual Care, n = 44 | Medical Care, n = 43 |
---|---|---|---|
Age, years, mean ± SD | 73.2 ± 6.2 | 72.3 ± 6.0 | 72.7 ± 6.4 |
Gender, male, n (%) | 28 (64) | 28 (64) | 24 (56) |
Race, white, n (%) | 40 (91) | 43 (98) | 40 (93) |
Employment, current, n (%) | 4 (9) | 11 (25) | 11 (26) |
Body mass index, mean ± SD | 31.9 ± 5.7 | 31.8 ± 7.3 | 31.7 ± 7.0 |
Timed Up & Go, seconds, mean ± SDa
| 12.3 ± 5.3 | 11.1 ± 2.6 | 11.6 ± 3.8 |
RAND-36, mean ± SD (range 0–100)b
| |||
Physical function | 50.0 ± 26.9 | 57.8 ± 23.6 | 65.0 ± 23.3 |
Emotional well-being | 78.5 ± 13.1 | 80.4 ± 14.0 | 77.8 ± 13.3 |
Patient Health Questionnaire, n (%) | |||
None-to-minimal depression | 27 (62) | 32 (73) | 31 (72) |
Mild-to-moderate depression | 15 (34) | 11 (25) | 12 (28) |
Generalized Anxiety Disorder, n (%) | |||
None-to-minimal anxiety | 37 (84) | 38 (86) | 34 (79) |
Mild-to-moderate anxiety | 7 (16) | 6 (13) | 9 (21) |
LBP onset, ≥1 year, n (%) | 40 (91) | 37 (84) | 33 (77) |
LBP days per week, median ± IQR | 7.0 ± 6.0 | 7.0 ± 5.0 | 7.0 ± 7.0 |
LBP medication use, past week, n (%) | |||
0 days of medication use | 15 (34) | 16 (36) | 16 (37) |
1–6 days of medication use | 14 (32) | 17 (38) | 17 (40) |
7 days of medication use | 15 (34) | 11 (25) | 10 (23) |
Types of LBP medication, n (%) | |||
Opioids or narcotics | 4 (9) | 4 (9) | 5 (12) |
Over-the-counter medicine | 23 (52) | 16 (36) | 17 (40) |
Non-steroidal anti-inflammatories | 17 (39) | 24 (55) | 19 (44) |
Sedatives or muscle relaxants | 7 (16) | 5 (11) | 5 (12) |
Days cut down on activity in past 4 weeks due to LBP, median ± IQR | 2 (0–10.0) | 4 (0–8.5) | 5 (0–20.0) |
Bothersomeness mean ± SD (range 1–5)a
| 3.5 ± 0.8 | 3.4 ± 0.8 | 3.3 ± 0.8 |
Fear avoidance beliefs, work or daily activity, mean ± SD (range 0–42)a
| 14.7 ± 8.7 | 13.0 ± 10.0 | 10.4 ± 8.4 |
Fear avoidance beliefs, physical activity, mean ± SD (range 0–24)a
| 12.8 ± 6.0 | 11.8 ± 6.2 | 12.0 ± 5.0 |
Numerical rating scale, average LBP in past week, mean ± SD (range 0–10)a
| 5.3 ± 1.9 | 6.0 ± 1.9 | 6.1 ± 1.9 |
Numerical rating scale, worst LBP in past week, mean ± SD (range 0–10)a
| 7.3 ± 1.5 | 7.4 ± 1.8 | 7.5 ± 1.5 |
Roland Morris Disability Questionnaire, mean ± SD (range 0–24)a
| 9.0 ± 5.2 | 7.1 ± 4.4 | 6.3 ± 4.9 |
Pain and disability outcomes
Variable | Treatment Group | Mean Change (95% CI) | Mean Difference (95% CI) | ||
---|---|---|---|---|---|
Shared vs. Dual | Shared vs. Medical | Dual vs. Medical | |||
Roland Morris Disability | Shared | 2.8 (1.6 to 4.0) | 0.3 (−1.5 to 2.0) | 1.3 (−0.5 to 3.0) | 1.0 (−0.8 to 2.8) |
Dual | 2.5 (1.3 to 3.7) | ||||
Medical | 1.5 (0.2 to 2.8) | ||||
NRS-Average | Shared | 1.8 (1.0 to 2.6) | −1.2 (−2.3 to −0.1) | −0.5 (−1.7 to 0.6) | 0.7 (−0.4 to 1.8) |
Dual | 3.0 (2.3 to 3.8) | ||||
Medical | 2.3 (1.5 to 3.2) | ||||
NRS-Worst | Shared | 2.1 (1.3 to 2.9) | −0.8 (−1.8 to 0.3) | −0.2 (−1.3 to 0.9) | 0.6 (−0.5 to 1.7) |
Dual | 2.9 (2.1 to 3.6) | ||||
Medical | 2.3 (1.5 to 3.1) | ||||
LBP Bothersomeness | Shared | 0.8 (0.4 to 1.1) | −0.2 (−0.6 to 0.3) | 0.2 (−0.3 to 0.6) | 0.3 (−0.1 to 0.8) |
Dual | 0.9 (0.6 to 1.2) | ||||
Medical | 0.6 (0.3 to 0.9) | ||||
FABQ-Work or Daily Activity | Shared | 3.5 (0.7 to 6.3) | 0.6 (−3.4 to 4.5) | 2.6 (−1.5 to 6.7) | 2.1 (−2.0 to 6.1) |
Dual | 2.9 (0.2 to 5.7) | ||||
Medical | 0.9 (−2.1 to 3.9) | ||||
FABQ-Physical Activity | Shared | 1.6 (−0.3 to 3.5) | −0.7 (−3.4 to 1.9) | 0.6 (−2.2 to 3.4) | 1.4 (−1.4 to 4.2) |
Dual | 2.3 (0.4 to 4.2) | ||||
Medical | 0.9 (−1.1 to 3.0) | ||||
Timed Up & Go | Shared | 0.9 (0.0 to 1.9) | 0.4 (−1.0 to 1.7) | 1.3 (−0.1 to 2.7) | 0.9 (−0.5 to 2.3) |
Dual | 0.5 (−0.4 to 1.5) | ||||
Medical | −0.4 (−1.4 to 0.7) |
Secondary clinical outcomes
Medication use
Global improvement and patient satisfaction
Adverse events
Treatment Group | Event Description | Grading |
---|---|---|
Shared Care | Hospitalization for flare up of existing chronic obstructive pulmonary disease | Serious, Unrelated to Study |
Dual Care | Hospitalization for amaurosis fugax and carotid artery blockage diagnosed by outside provider during study enrollment process | Serious, Unrelated to Study |
Dual Care | Hospitalization for pneumonia and atrial fibrillation | Serious, Unrelated to Study |
Dual Care | Hospitalization for chest pain diagnosed as reflux esophagitis by outside provider | Serious, Unrelated to Study |
Medical Care | Hospitalization for accidental fall with pneumothorax | Serious, Unrelated to Study |
Unallocated | Hospitalization for renal lithiasis with sepsis during study enrollment process | Serious, Unrelated to Study |
Shared Care | Hospitalization for chest pain with cardiac catheterization | Serious, Unlikely Related to Study |
Dual Care | Hospitalization for ischemic colitis | Serious, Unlikely Related to Study |
Shared Care | Medication side effect of vomiting after taking a muscle relaxant that resolved with discontinuation | Moderate, Definitely Related to Study |
Shared Care | Medication side effect of dermal burning sensations from a nicotine patch that resolved with discontinuation | Mild, Definitely Related to Study |
Medical Care | Medication side effect of jerking sensations in an arm after gabapentin use that resolved with a dose change | Mild, Possibly Related to Study |