Table 2.
Secondary outcomes at 4 months and 12 months
| Stratified care | Usual care | Between-arm effect (95% CI) | p value | ||
|---|---|---|---|---|---|
| Physical function (RMDQ, 0–23) | |||||
| 4 months (stratified care; n=192, usual care; n=201) | 6·5 (6·3) | 6·2 (6·0) | MD 0·43 (−0·69 to 1·54) | p=0·45 | |
| 12 months (stratified care; n=177, usual care; n=182) | 5·0 (6·2) | 5·5 (6·0) | MD −0·53 (−1·84 to 0·78) | p=0·43 | |
| Global perceived change (GPC) | |||||
| 4 months (stratified care; n=188, usual care; n=194) | |||||
| Completely recovered | 28 (15%) | 26 (13%) | .. | .. | |
| Much Better | 50 (27%) | 59 (30%) | .. | .. | |
| Better | 48 (26%) | 59 (30%) | OR 0·88 (0·51 to 1·53) | p=0·66 | |
| No change | 39 (21%) | 32 (16%) | .. | .. | |
| Worse | 23 (12%) | 18 (9%) | .. | .. | |
| 12 months (stratified care; n=174, usual care; n=176) | |||||
| Completely recovered | 34 (20%) | 30 (17%) | .. | .. | |
| Much Better | 63 (36%) | 58 (33%) | .. | .. | |
| Better | 34 (20%) | 42 (24%) | OR 1·43 (0·80 to 2·53) | p=0·22 | |
| No change | 30 (17%) | 34 (19%) | .. | .. | |
| Worse | 13 (7%) | 12 (7%) | .. | .. | |
| Usual back pain (NRS 0–10) | |||||
| 4 months (stratified care; n=154, usual care; n=158) | 3·8 (2·8) | 3·4 (2·6) | MD 0·32 (−0·30 to 0·94) | p=0·31 | |
| 12 months (stratified care; n=123, usual care; n=130) | 3·2 (2·8) | 2·7 (2·5) | MD 0·26 (−0·48 to 1·01) | p=0·49 | |
| Usual leg pain (NRS 0–10) | |||||
| 4 months (stratified care; n=191, usual care; n=197) | 3·3 (2·9) | 3·1 (2·8) | MD 0·25 (−0·36 to 0·86) | p=0·42 | |
| 12 months (stratified care; n=176, usual care; n=178) | 2·9 (2·9) | 2·8 (2·8) | MD 0·11 (−0·56 to 0·77) | p=0·75 | |
| SBI (0–24) | |||||
| 4 months (stratified care; n=150, usual care; n=155) | 7·9 (6·0) | 7·5 (5·3) | MD 0·26 (−1·03 to 1·55) | p=0·69 | |
| 12 months (stratified care; n=122, usual care; n=126) | 6·7 (5·7) | 6·5 (6·1) | MD −0·42 (−1·94 to 1·11) | p=0·59 | |
| S-LANSS (≥12) | |||||
| 4 months (stratified care; n=136, usual care; n=138) | 35 (26%) | 33 (24%) | OR 1·17 (0·49 to 2·79) | p=0·72 | |
| 12 months (stratified care; n=98, usual care; n=105) | 22 (22%) | 22 (21%) | OR 1·08 (0·39 to 2·98) | p=0·88 | |
| Fear of movement (TSK, 17–64) | |||||
| 4 months (stratified care; n=145, usual care; n=154) | 36·9 (8·4) | 36·2 (7·4) | MD 0·53 (−0·87 to 1·92) | p=0·46 | |
| 12 months (stratified care; n=117, usual care; n=122) | 35·2 (8·5) | 35·3 (7·8) | MD −0·37 (−1·88 to 1·13) | p=0·63 | |
| HADS-Anxiety case | |||||
| 4 months (stratified care; n=150, usual care; n=157) | |||||
| Normal (0–7) | 104 (69%) | 103 (66%) | .. | .. | |
| Possible (8–10) | 26 (17%) | 37 (24%) | OR 1·36 (0·59 to 3·13) | p=0·48 | |
| Probable (≥11) | 20 (13%) | 17 (11%) | .. | .. | |
| 12 months (stratified care; n=119, usual care; n=133) | |||||
| Normal (0–7) | 75 (63%) | 97 (73%) | .. | .. | |
| Possible (8–10) | 21 (18%) | 16 (12%) | OR 2·30 (0·94 to 5·65) | p=0·070 | |
| Probable (≥11) | 23 (19%) | 20 (15%) | .. | .. | |
| HADS-Depression case | |||||
| 4 months (stratified care; n=150, usual care; n=158) | |||||
| Normal (0–7) | 117 (78%) | 121 (77%) | OR 0·99 (0·41 to 2·42) | p=0·99 | |
| Possible (8–10) | 18 (12%) | 19 (12%) | .. | .. | |
| Probable (≥11) | 15 (10%) | 18 (11%) | .. | .. | |
| 12 months (stratified care; n=119, usual care; n=133) | |||||
| Normal (0–7) | 89 (75%) | 103 (77%) | OR 1·24 (0·48 to 3·22) | p=0·66 | |
| Possible (8–10) | 18 (15%) | 15 (11%) | .. | .. | |
| Probable (≥11) | 12 (10%) | 15 (11%) | .. | .. | |
| Sleep problem (yes) | |||||
| 4 months (stratified care; n=154, usual care; n=159) | 54 (35%) | 61 (38%) | OR 1·59 (0·66 to 3·82) | p=0·30 | |
| 12 months (stratified care; n=124, usual care; n=132) | 42 (34%) | 41 (31%) | OR 2·21 (0·85 to 5·72) | p=0·10 | |
| General health | |||||
| 4 months (stratified care; n=153, usual care; n=158) | |||||
| Excellent | 5 (3%) | 10 (6%) | .. | .. | |
| Very good | 47 (31%) | 35 (22%) | .. | .. | |
| Good | 60 (39%) | 69 (44%) | OR 1·21 (0·65 to 2·24) | p=0·56 | |
| Fair | 32 (21%) | 35 (22%) | .. | ||
| Poor | 9 (6%) | 9 (6%) | .. | ||
| 12 months (stratified care; n=120, usual care; n=133) | |||||
| Excellent | 9 (8%) | 12 (9%) | .. | .. | |
| Very good | 43 (36%) | 42 (32%) | .. | .. | |
| Good | 39 (33%) | 47 (35%) | OR 1·49 (0·76 to 2·94) | p=0·25 | |
| Fair | 27 (23%) | 24 (18%) | .. | .. | |
| Poor | 2 (2%) | 8 (6%) | .. | .. | |
| Time off work (yes) | |||||
| 4 months (stratified care; n=107, usual care; n=96) | 45 (42%) | 47 (49%) | OR 1·11 (0·47 to 2·61) | p=0·82 | |
| 12 months (stratified care; n=75, usual care; n=81) | 20 (27%) | 15 (19%) | OR 2·52 (0·85 to 7·49) | p=0·095 | |
Data are n (%) or mean (SD). MD=mean difference (stratified care minus usual care) by longitudinal linear mixed model adjusted for centre, group, duration of baseline symptoms (fixed effects) and clustering by physiotherapist and participant (random effects). OR=odds ratio (stratified care relative to usual care) by longitudinal logistic (ordinal for three or more categories, binary for two categories) mixed model adjusted for centre, group, duration of baseline symptoms (fixed effects) and clustering by physiotherapist and participant (random effects). RMDQ=Roland-Morris Disability Questionnaire (0–23, with higher scores indicating higher levels of disability). GPC=Global Perceived Change (rescaled as 1–5; 1=worse, 5=completely recovered); NRS=Numerical Rating Scale (0–10, with higher scores indicating worse symptoms). SBI=Sciatica Bothersomeness Index (0–24 composite score with higher scores indicating worse symptoms). S-LANSS=Self-report Leeds Assessment of Neuropathic Symptoms and Signs (possible range from 0 to 24, with a score of 12 or more indicating possible neuropathic pain). TSK=Tampa Scale of Kinesiophobia (17–64, with higher scores indicating higher fear of movement). HADS=Hospital Anxiety Depression Scale (0–21, with higher scores indicating higher levels of anxiety or depressive symptoms, with a cutoff point of ≥11 considered indicative of “probable case” of depression or anxiety).