Biopsychosocial primary care versus physiotherapy as usual in chronic low back pain: results of a pilot-randomised controlled trial

Figures & data

Table 1. Content of the back on track intervention.

Sessions	Content/strategy		Duration
Individual session	History taking		30 min
	Pain education		30 min
	Goal setting		30 min
Group sessions	Theme 1—pain and physical activity
		Session 1 education	60 min
		Session 2 education + physical activity	60 min
	Theme 2—Pain and social network
		Session 1 education	60 min
		Session 2 education + physical activity	60 min
	Theme 3—Pain and cognitions
		Session 1 education	60 min
		Session 2 education + physical activity	60 min
	Theme 4—Fact or myth?
		Session 1 education	60 min
		Session 2 education + physical activity	60 min
Individual session		Evaluation	30 min

Figure 1. Flow chart of the study participants.

Table 2. Baseline characteristics of study participants.

	Back on Track intervention (n = 12)	Physiotherapy as usual (n = 13)
Age (years)—mean (SD)	43 (12)	45 (12)
Sex (female)—n (%)	7 (58%)	7 (54%)
Nationality—n (%)
Dutch	12 (100%)	12 (92%)
Other	0 (0%)	1 (8%)
Employment—n (%)
Full-time	6 (50%)	6 (46%)
Part-time	5 (42%)	6 (46%)
Full-time education	1 (8%)	1 (8%)
Education level—n (%)
Low	2 (17%)	3 (23%)
Middle	5 (42%)	8 (62%)
High	5 (42%)	2 (15%)
Duration of low back pain (since first onset)—n (%)
3–6 months	1 (8%)	0 (0%)
6–12 months	1 (8%)	1 (8%)
1–2 years	1 (8%)	3 (23%)
2–5 years	5 (42%)	7 (54%)
>5 years	4 (33%)	2 (15%)
Functional disability (QBPDS)—mean (SD)	31 (12)	38 (15)
Functional disability (PDI)—mean (SD)	25 (15.4)	28 (12.3)
Pain intensity (NRS)—median (range)	6.0 (2–8)	7.0 (3–9)
Pain catastrophizing (PCS)—mean (SD)	14 (10.4)	16 (9.2)
Anxiety and depression (HADS)
Anxiety—median (range)	5.0 (0–9)	4.0 (0–18)
Depression—mean (SD)	3.8 (3.2)	3.9 (3.0)
Kinesiophobia (TSK)—mean (SD)	32 (7.2)	35 (6.1)
Pain self-efficacy (PSEQ)—mean (SD)	46 (8.8)	42 (12.9)
Physical functioning (RAND-36, subscale)—median (range)	68 (25–95)	70 (20–75)
Mental health (RAND-36, subscale)—mean (SD)	78 (16.8)	75 (21.6)
Credibility (CEQ)^a—mean (SD)	30 (8.7)	32 (6.2)
Expectancy (CEQ)^a—mean (SD)	36 (11)	39 (8.0)

QBPDS: Quebec Back Pain Disability Scale (0–100); HADS: Hospital Anxiety and Depression Scale (0–21 per subscale); NRS: Numeric Rating Scale (0–10), average pain last week; PCS: Pain Catastrophizing Scale (0–52); PSEQ: Pain Self Efficacy Questionnaire (0–60); TSK: Tampa Scale for Kinesiophobia (17–68); RAND-36: RAND-36 item Health Survey (0–100 per subscale); Credibility and Expectancy Scale (credibility 5–45, expectancy 6–54).

^aCEQ is measured directly after the first therapy session; Back on Track n = 8, physiotherapy as usual n = 11.

Table 3. Estimates of clinical effectiveness at post-treatment and 3 months follow-up.

	Mean score (95% CI) within intervention group		Mean change (95% CI) within intervention group
	Back on track intervention (n = 12)	Physiotherapy as usual (n = 13)	Back on track intervention (n = 12)	Physiotherapy as usual (n = 13)	Mean treatment difference (95% CI)between intervention groups	p-value
QBPDS
Baseline	30.7 (20.5–40.8)	37.8 (28.1–47.6)
Post-treatment	27.2 (15.8–38.5)	34.2 (23.8–44.6)	−3.5 (−13.2–6.2)	−3.6 (−12.3–5.1)	0.10 (−12.9–13.1)	.987
3 months follow-up	21.9 (9.6–34.1)	34.5 (24.3–44.6)	−8.8 (−19.6–2.0)	−3.4 (−11.8–5.0)	−5.4 (−19.1–8.3)	.428
NRS
Baseline	5.3 (4.0–6.5)	6.5 (5.3–7.8)
Post-treatment	5.5 (3.9–7.0)	5.7 (4.3–7.1)	0.22 (−1.5–2.0)	−0.86 (−2.4–0.72)	1.1 (−1.3–3.4)	.356
3 months follow-up	5.0 (3.2–6.7)	5.6 (4.3–7.0)	−0.28 (−2.2–1.6)	−0.90 (−2.4–0.63)	0.63 (−1.8–3.1)	.609
PCS
Baseline	14.3 (8.7–19.8)	15.8 (10.4–21.1)
Post-treatment	8.4 (2.0–14.8)	16.2 (10.4–22.0)	−5.8 (−11.8–0.14)	0.41 (−5.0–5.8)	−6.2 (−14.3–1.8)	.123
3 months follow-up	12.6 (5.6–19.6)	15.7 (10.1–21.4)	−1.7 (−8.3–5.0)	−0.05 (−5.3–5.2)	−1.6 (−10.1–6.8)	.697
HADS, subscale anxiety
Baseline	4.2 (2.1–6.2)	5.3 (3.3–7.3)
Post-treatment	3.6 (1.3–5.9)	4.3 (2.3–6.4)	−0.57 (−2.3–1.2)	−0.96 (−2.4–0.47)	0.39 (−1.9–2.7)	.728
3 months follow-up	3.3 (0.90–5.7)	4.7 (2.7–6.8)	−0.88 (−2.8–0.99)	−0.60 (−2.0–0.84)	−0.28 (−2.6–2.1)	.808
HADS, subscale depression^a
Baseline	5.0 (3.0–6.9)	4.8 (2.7–6.8)
Post-treatment	4.0 (1.8–6.2)	4.8 (2.6–6.9)	−0.91 (−2.9–1.1)	0.03 (−1.6–1.7)	−0.94 (−3.5–1.6)	.459
3 months follow-up	3.1 (0.87–5.4)	5.3 (3.2–7.5)	−1.8 (−3.9–0.28)	0.57 (−1.1–2.2)	−2.4 (−5.0–0.26)	.076
PSEQ
Baseline	45.9 (39.1–52.8)	42.3 (35.7–48.9)
Post-treatment	45.8 (37.9–53.6)	41.9 (34.8–49.1)	−0.14 (-7.7–7.4)	−0.38 (−7.2–6.4)	0.23 (−9.9–10.4)	.962
3 months follow-up	50.4 (41.7–59.0)	42.8 (35.8–49.7)	4.5 (-3.9–12.9)	0.44 (−6.1–7.0)	4.1 (−6.6–14.7)	.445
TSK^a
Baseline	34.7 (30.6–38.7)	36.0 (31.7–40.4)
Post-treatment	34.0 (29.5–38.6)	40.1 (35.5–44.7)	−0.64 (−5.1–3.8)	4.1 (0.04–8.1)	−4.7 (−10.7–1.3)	.117
3 months follow-up	34.5 (29.5–39.4)	38.4 (33.8–42.9)	−0.21 (−5.2–4.7)	2.3 (−1.6–6.2)	−2.5 (−8.8–3.8)	.420
GPE, subscale recovery^b
Post-treatment	4.8 (4.2–5.3)	4.5 (4.0–5.0)			0.23 (−0.55–1.00)^c	.545
3 months follow-up	4.9 (4.3–5.6)	4.5 (4.0–5.0)	0.19 (−0.26–0.63)	−0.07 (−0.42–0.29)	0.48 (−0.31–1.27)^c	.222
GPE, subscale satisfaction^b
Post-treatment	4.6 (3.4–5.8)	4.5 (3.4–5.5)			0.16(−1.41–1.73)^c	.832
3 months follow-up	4.6 (3.3–5.9)	3.7 (2.7–4.7)	−0.01 (−1.1–1.0)	−0.74 (−1.6–0.09)	0.89 (−0.73–2.51)^c	.270

HADS: Hospital Anxiety and Depression Scale (0–21 per subscale); GPE: Global Perceived Effect (1–7 per subscale); QBPDS: Quebec Back Pain Disability Scale (0–100); NRS: Numeric Rating Scale (0–10), average pain last week; PCS: Pain Catastrophizing Scale (0–52); PSEQ: Pain Self-Efficacy Questionnaire (0–60); TSK: Tampa Scale for Kinesiophobia (17–68).

^aMean score and mean change were as average over the five categories of the significant variable duration of low back pain.

^bBack on Track n = 8, physiotherapy as usual n = 11.

^cMean difference between interventions, analysed by Mann–Whitney U test showing no significant difference.