Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

Hurley, Deirdre A.; Jeffares, Isabelle; Hall, Amanda M.; Keogh, Alison; Toomey, Elaine; McArdle, Danielle; McDonough, Suzanne M.; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

doi:10.1186/s13063-020-04671-x

Trials

Table 4 Model-predicted mean (95% CI) outcomes per group over time

From: Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

Outcome	Group	Time							No. clusters	Cluster ICC	Participant ICC
Outcome	Group	Baseline		6 weeks	2 months		6 months		No. clusters	Cluster ICC	Participant ICC
Short-form 12 physical component score (SF12-PCS)
Score (0–100)	Usual PT	N = 61	40.0 (37.8, 42.3)		N = 51	43.7 (41.3, 46.1)	N = 43	43.7 (41.2, 46.3)	7	0.0	0.56
Score (0–100)	SOLAS	N = 59	39.9 (37.6, 42.2)		N = 50	44.1 (41.7, 46.6)	N = 43	42.2 (39.6, 44.8)	7	0.0	0.56
Pain
Intensity [NRS, 0–10]	Usual PT	N = 61	6.2 (5.5, 6.8)		N = 51	4.3 (3.6, 4.9)	N = 43	4.6 (3.9, 5.4)	7	0.0	0.38
Intensity [NRS, 0–10]	SOLAS	N = 59	5.7 (5.1, 6.4)		N = 50	4.8 (4.1, 5.4)	N = 43	4.3 (3.6, 5.1)	7	0.0	0.38
Bothersomeness 0–10)	Usual PT	N = 61	3.2 (2.9, 3.5)		N = 51	2.6 (2.3, 2.9)	N = 43	2.6 (2.3, 2.9)	7	0.0	0.35
Bothersomeness 0–10)	SOLAS	N = 59	3.0 (2.7, 3.3)		N = 50	2.7 (2.4, 3.0)	N = 43	2.7 (2.4, 3.0)	7	0.0	0.35
Roland Morris disability questionnaire (RMDQ)
Total score (0–24)	Usual PT	N = 41	12.2 (10.3, 14.1)		N = 33	7.9 (5.9, 9.8)	N = 26	6.6 (4.5, 8.7)	7	0.0	0.67
Total score (0–24)	SOLAS	N = 34	13.0 (11,0, 15.1)		N = 29	9.5 (7.4, 11.7)	N = 25	9.4 (7.1, 11.6)	7	0.0	0.67
Western Ontario and McMaster Universities Arthritis Index (WOMAC) function daily living
Hip subscale score (0–68)	Usual PT	N = 14	21.5 (13.4, 29.5)		N = 12	23.4 (15.2, 31.6)	N = 10	22.4 (14.0, 30.8)	7	0.27	0.49
Hip subscale score (0–68)	SOLAS	N = 12	24.7 (16.3, 33.1)		N = 9	23.4 (14.5, 32.3)	N = 10	22.1 (13.4, 30.9)	7	0.27	0.49
Knee subscale score (0–68)	Usual PT	N = 26	21.1 (15.7, 26.6)		N = 21	20.8 (15.0, 26.7)	N = 19	23.7 (17.7, 29.7)	7	0.13	0.50
Knee subscale score (0–68)	SOLAS	N = 29	24.8 (19.5, 30.2)		N = 27	23.9 (18.4, 29.3)	N = 21	26.7 (20.9, 32.6)	7	0.13	0.50
Hospital anxiety and depression scale (HADS)
Total score (0–42)	Usual PT	N = 61	12.5 (10.6, 14.4)		N = 48	10.3 (8.3, 12.3)	N = 43	10.1 (8.0, 12.1)	7	0.22	0.51
Total score (0–42)	SOLAS	N = 58	12.1 (10.2, 14.1)		N = 45	9.1 (7.1, 11.2)	N = 39	8.8 (6.7, 10.9)	7	0.22	0.51
Anxiety scale (0–21)	Usual PT	N = 61	7.3 (6.2, 8.4)		N = 48	5.7 (4.5, 6.8)	N = 43	5.4 (4.2, 6.6)	7	0.05	0.66
Anxiety scale (0–21)	SOLAS	N = 58	7.2 (6.1, 8.4)		N = 45	5.2 (4.0, 6.4)	N = 39	5.1 (3.8, 6.3)	7	0.05	0.66
Depression scale (0–21)	Usual PT	N = 61	5.1 (4.2, 6.1)		N = 48	4.6 (3.6, 5.6)	N = 43	4.57 (3.5, 5.6)	7	0.31	0.31
Depression scale (0–21)	SOLAS	N = 58	5.0 (4.0, 5.9)		N = 45	4.0 (2.9, 5.0)	N = 39	3.69 (2.6, 4.8)	7	0.31	0.31
Global perceived effect scale (GPE)
Total score (−5 to + 5)	Usual PT	N = 61	−2.0 (−2.8, −1.2)		N = 50	1.9 (1.1, 2.7)	N = 43	1.1 (0.2, 2.0)	7	0.0	0.0
Total score (−5 to + 5)	SOLAS	N = 59	−1.9 (− 2.7, 1.1)		N = 49	1.7 (0.9, 2.6)	N = 41	1.4 (0.5, 2.3)	7	0.0	0.0
EuroQol 5-D (EQ5D)^a
Weighted Health Index, median [IQR], (−.59 to + 1.00)	Usual PT	N = 61	0.69 (0.59, 0.73)		N = 49	0.73 (0.66, 0.80)	N = 43	0.73 (0.62, 0.80)	7	N/A	N/A
Weighted Health Index, median [IQR], (−.59 to + 1.00)	SOLAS	N = 59	0.69 (0.62, 0.76)		N = 45	0.73 (0.69, 0.76)	N = 39	0.69 (0.62, 0.80)	7	N/A	N/A

^aNon-normal distributions, descriptive statistics only presented

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