Table 2.
Summary of secondary health outcome measures by treatment group. Values are mean score (SD), number, unless stated otherwise
| Outcome measures | BCT | BCT+ultrasound-triamcinolone-lidocaine | BCT+ultrasound-lidocaine | Effect size (95% CI) | |
|---|---|---|---|---|---|
| BCT+ultrasound-triamcinolone-lidocaine v BCT | BCT+ultrasound-triamcinolone-lidocaine v BCT+ultrasound-lidocaine | ||||
| WOMAC | |||||
| 2 months | 50.3 (21.1), 55 | 34.2 (20.3), 61 | 41.4 (19.2), 62 | −14.77 (−20.91 to −8.64)* | −6.68 (−12.59 to −0.76)† |
| 4 months | 43.6 (23.1), 51 | 38.3 (20.7), 59 | 43.9 (18.5), 56 | −6.38 (−12.54 to −0.21)† | −6.42 (−12.39 to −0.45)† |
| 6 months | 42.9 (22.6), 53 | 41.8 (20.8), 55 | 44.0 (19.4), 59 | −1.42 (−7.68 to 4.84) | −0.78 (−6.82 to 5.27) |
| Overall | 45.7 (22.4), 60 | 38.0 (20.7), 64 | 43.0 (19.0), 65 | −7.52 (−13.00 to −2.04)‡ | −4.62 (−9.91 to 0.67) |
| Subscales: | |||||
| Pain | 9.6 (4.4) | 7.9 (4.3) | 9.0 (4.1) | −1.78 (−3.01 to −0.54)‡ | −1.07 (−2.26 to 0.12) |
| Stiffness | 3.9 (1.9) | 3.5 (1.8) | 3.8 (1.8) | −0.53 (−1.08 to 0.01) | −0.23 (−0.76 to 0.30) |
| Function | 32.1 (16.7) | 26.4 (15.1) | 30.4 (14.0) | −5.47 (−9.41 to −1.53)‡ | −3.60 (−7.40 to 0.21) |
| PSEQ | |||||
| 2 months | 34.3 (15.9), 55 | 44.4 (14.2), 62 | 39.2 (13.6), 63 | 9.27 (5.10 to 13.44)* | 6.18 (2.15 to 10.20)‡ |
| 4 months | 35.2 (16.7), 52 | 41.2 (15.0), 60 | 37.9 (13.2), 59 | 6.71 (2.51 to 10.92)‡ | 5.27 (1.21 to 9.34)† |
| 6 months | 37.8 (14.7), 53 | 38.8 (15.1), 58 | 36.9 (12.8), 59 | 1.64 (−2.62 to 5.90) | 2.88 (−1.24 to 7.00) |
| Overall | 35.7 (15.7), 60 | 41.5 (14.9), 65 | 38.0 (13.2), 65 | 5.87 (2.30 to 9.45)‡ | 4.78 (1.32 to 8.23)‡ |
| IPQ | |||||
| 2 months | 33.0 (9.23), 51 | 27.2 (10.6), 60 | 30.0 (8.64), 60 | −6.04 (−9.23 to −2.84)* | −2.55 (−5.59 to 0.48) |
| 6 months | 30.1 (9.16), 49 | 30.0 (9.03), 53 | 29.2 (9.49), 58 | −0.15 (−3.44 to 3.14) | 0.79 (−2.33 to 3.91) |
| Overall | 31.6 (9.27), 58 | 28.5 (9.94), 63 | 29.6 (9.04), 65 | −3.10 (−5.92 to −0.27)† | −0.88 (−3.57 to 1.80) |
| Subscales: | |||||
| Consequences | 6.0 (2.6) | 5.5 (2.7) | 5.9 (2.3) | −0.55 (−1.27 to 0.17) | −0.35 (−1.04 to 0.35) |
| Timeline | 8.7 (2.1) | 8.7 (2.2) | 8.4 (2.2) | 0.07 (−0.74 to 0.60) | 0.40 (−0.25 to 1.05) |
| Personal control | 4.3 (2.7) | 4.5 (2.9) | 4.2 (2.7) | 0.12 (−0.93 to 0.69) | 0.25 (−0.52 to 1.03) |
| Treatment control | 3.9 (2.9) | 6.1 (3.2) | 5.0 (3.1) | 2.13 (1.11 to 3.15)* | 0.98 (0.01 to 1.95)† |
| Emotional response | 5.2 (2.9) | 4.7 (3.1) | 4.8 (2.9) | −0.63 (−1.43 to 0.16) | −0.43 (−1.19 to 0.33) |
| SF-12 PCS | |||||
| 2 months | 32.8 (8.0), 55 | 39.1 (9.8), 59 | 35.0 (9.5), 60 | 5.30 (2.38 to 8.21)* | 4.05 (1.20 to 6.89)‡ |
| 4 months | 35.7 (10.8), 53 | 39.0 (10.6), 58 | 33.7 (9.7), 53 | 3.07 (0.13 to 6.01)† | 5.31 (2.41 to 8.21)* |
| 6 months | 33.7 (9.9), 50 | 37.7 (10.1), 51 | 34.0 (9.5), 54 | 3.04 (0 to 6.08) | 2.15 (−0.81 to 5.11) |
| Overall | 34.1 (9.6), 60 | 38.7 (10.1), 64 | 34.2 (9.6), 64 | 3.80 (1.33 to 6.27)‡ | 3.84 (1.43 to 6.24)‡ |
| SF-MCS | |||||
| 2 months | 47.5 (12.9), 50 | 50.2 (12.0), 59 | 50.1 (12.3), 60 | 1.09 (−2.69 to 4.87) | −1.05 (−4.73 to 2.63) |
| 4 months | 46.3 (13.5), 53 | 49.4 (12.4), 58 | 49.9 (11.8), 53 | 2.01 (−1.80 to 5.83) | 0.33 (−3.44 to 4.10) |
| 6 months | 49.8 (12.7), 50 | 48.7 (11.9), 51 | 49.2 (12.2), 54 | −2.63 (−6.61 to 1.35) | −0.50 (−4.37 to 3.37) |
| Overall | 47.8 (13.0), 60 | 49.5 (12.0), 64 | 49.8 (12.0), 64 | 0.16 (−2.83 to 3.15) | 0.29 (−2.60 to 3.19) |
| EQ5D-5L | |||||
| 2 weeks | 0.47 (0.27), 61 | 0.64 (0.23), 63 | 0.59 (0.22), 64 | 0.18 (0.12 to 0.24)* | 0.06 (0 to 0.12) |
| 2 months | 0.44 (0.29), 56 | 0.60 (0.26), 62 | 0.52 (0.24), 64 | 0.15 (0.08 to 0.22)* | 0.07 (0 to 0.14)† |
| 4 months | 0.48 (0.28), 56 | 0.59 (0.23), 58 | 0.48 (0.28), 62 | 0.12 (0.04 to 0.19)‡ | 0.10 (0.03 to 0.18)‡ |
| 6 months | 0.52 (0.25), 54 | 0.50 (0.25), 57 | 0.50 (0.24), 60 | 0.01 (−0.07 to 0.08) | 0.00 (−0.07 to 0.08) |
| Overall | 0.48 (0.27), 63 | 0.58 (0.25), 66 | 0.52 (0.25), 65 | 0.11 (0.06 to 0.17)* | 0.06 (0.01 to 0.11)† |
| SPS | |||||
| 2 months | 20.0 (6.0), 22 | 23.4 (4.4), 35 | 20.1 (6.0), 27 | 4.06 (1.75 to 6.38)‡ | 3.40 (1.22 to 5.59)‡ |
| 6 months | 19.9 (6.6), 21 | 21.8 (5.1), 32 | 20.0 (4.7), 26 | 2.16 (−0.20 to 4.53) | 2.45 (0.22 to 4.69)† |
| Overall | 19.9 (6.2), 43 | 22.7 (4.8), 67 | 20.1 (5.4), 53 | 3.11 (1.05 to 5.18)‡ | 2.93 (0.98 to 4.88)‡ |
| Work performance | |||||
| 2 months | 4.1 (3.0), 21 | 3.1 (2.4), 32 | 4.9 (3.0), 28 | −1.72 (−2.93 to −0.51)‡ | −1.49 (−2.64 to −0.34)† |
| 6 months | 4.4 (3.2), 21 | 4.2 (2.7), 32 | 4.5 (2.7), 26 | −0.84 (−2.08 to 0.39) | −0.47 (−1.64 to 0.71) |
| Overall | 4.3 (3.1), 25 | 3.6 (2.6), 37 | 4.7 (2.8), 30 | −1.28 (−2.39 to −0.18)† | −0.98 (−2.03 to 0.07) |
| Body mass index | |||||
| 6 months | 29.2 (6.1), 52 | 29.2 (5.4), 56 | 28.0 (4.7), 57 | −0.22 (−0.91 to 0.46) | 0.10 (−0.55 to 0.74) |
| Perceived change (No (%)) | |||||
| 2 weeks: | |||||
| Completely better§ | 0 (0) | 2 (3) | 1 (2) | RR=6.93 (3.39 to 14.17)* ¶ | RR=2.28 (1.42 to 3.66)* |
| Much better§ | 0 (0) | 34 (53) | 15 (23) | RD=65 (26 to 100) | RD=31 (10 to 64) |
| Somewhat better | 7 (11) | 14 (22) | 20 (31) | NNT=2 (1 to 4) | NNT=3 (2 to 10) |
| Same | 39 (63) | 10 (16) | 23 (36) | — | — |
| Somewhat worse | 10 (16) | 4 (6) | 4 (6) | — | — |
| Much worse | 6 (10) | 0 (0) | 1 (2) | — | — |
| 2 months: | |||||
| Completely better§ | 1 (2) | 2 (3) | 0 (0) | RR=6.66 (2.48 to 17.85)* | RR=2.63 (1.43 to 4.82)‡ |
| Much better§ | 3 (5) | 28 (42) | 11 (17) | RD=40 (10 to 100) | RD=28 (7 to 65) |
| Somewhat better | 6 (10) | 9 (14) | 21 (32) | NNT=3 (1 to 10) | NNT=4 (2 to 14) |
| Same | 27 (47) | 14 (21) | 19 (29) | — | — |
| Somewhat worse | 16 (28) | 9 (14) | 12 (19) | — | — |
| Much worse | 5 (9) | 4 (6) | 2 (3) | — | — |
| 4 months: | |||||
| Completely better§ | 0 (0) | 1 (2) | 0 (0) | RR=1.54 (0.32 to 1.32) | RR=1.85 (0.88 to 3.88) |
| Much better§ | 10 (17) | 15 (25) | 9 (14) | RD=9 (−12 to 5) | RD=12 (−2 to 40) |
| Somewhat better | 5 (9) | 15 (25) | 10 (16) | NNT=11 (20 to −8) | NNT=8 (−50 to 3) |
| Same | 17 (30) | 14 (23) | 24 (38) | — | — |
| Somewhat worse | 16 (28) | 13 (22) | 14 (22) | — | — |
| Much worse | 9 (16) | 2 (3) | 6 (10) | — | — |
| 6 months: | |||||
| Completely better§ | 2 (4) | 1 (2) | 0 (0) | RR=0.91 (0.55 to 2.17) | RR=1.27 (0.62 to 2.58) |
| Much better§ | 10 (18) | 13 (21) | 11 (18) | RD=−2 (−10 to 26) | RD=5 (−7 to 28) |
| Somewhat better | 7 (12) | 13 (21) | 12 (20) | NNT=−50 (4 to −10) | NNT=20 (4 to −14) |
| Same | 14 (25) | `13 (21) | 18 (29) | — | — |
| Somewhat worse | 14 (25) | 18 (30) | 15 (25) | — | — |
| Much worse | 9 (16) | 3 (5) | 5 (8) | — | — |
| Sleep disturbance | |||||
| 2 months: | |||||
| No nights§ | 4 (7) | 12 (19) | 7 (11) | RR=1.96 (1.28 to 3.03)‡ | RR=1.72 (1.12 to 2.63)† |
| 1-2 nights§ | 5 (9) | 16 (25) | 5 (8) | RD=45 (13 to 95) | RD=36 (6 to 82) |
| Some nights§ | 17 (31) | 15 (24) | 19 (31) | NNT=2 (1 to 8) | NNT=3 (1 to 17) |
| Most nights | 15 (27) | 12 (19) | 17 (27) | — | — |
| Every night | 14 (25) | 8 (13) | 14 (23) | — | — |
| 4 months: | |||||
| No nights§ | 8 (15) | 9 (15) | 6 (10) | RR=1.27 (0.79 to 2.04) | RR=1.56 (1.06 to 2.27)† |
| 1-2 nights§ | 9 (17) | 13 (22) | 9 (15) | RD=17 (−13 to 64) | RD=25 (3 to 57) |
| Some nights§ | 16 (30) | 15 (25) | 12 (20) | NNT=6 (2 to −7) | NNT=4 (2 to 33) |
| Most nights | 13 (24) | 14 (24) | 25 (41) | — | — |
| Every night | 8 (15) | 8 (14) | 9 (15) | — | — |
| 6 months: | |||||
| No nights§ | 9 (17) | 8 (14) | 7 (12) | RR=1.05 (0.69 to 1.45) | RR=1.10 (0.79 to 1.52) |
| 1-2 nights§ | 6 (12) | 5 (9) | 5 (8) | RD=3 (−18 to 26) | RD=5 (−10 to 24) |
| Some nights§ | 15 (29) | 14 (25) | 16 (27) | NNT=33 (4 to −6) | NNT=20 (4 to −10) |
| Most nights | 15 (29) | 15 (26) | 21 (35) | — | — |
| Every night | 7 (13) | 15 (26) | 11 (18) | — | — |
SD=standard deviation; BCT=best current treatment; CI=confidence interval; RR=relative risk; RD=percentage risk difference (derived as product of RR and observed positive proportion in BCT group (rounded to nearest integer and converted to percentage) minus observed positive percentage in BCT group); NNT=number needed to treat (=100/RD (rounded to nearest integer)).
Relative risk (RR) is shown for dichotomised outcomes. P values are analyses by linear or generalised mixed models accounting for repeated measures and adjusted for age, sex, baseline pain intensity, and (when applicable) corresponding baseline value.
WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index (total: 0=minimum problems, 96=maximum problems; pain: 0=no pain, 20=maximal pain; stiffness: 0=no stiffness, 8=most stiffness; function: 0=no difficulty, 68=most difficulty) PSEQ=Pain Self-Efficacy Questionnaire (0=no confidence, 60=highest confidence); IPQ=modified brief Illness Perceptions Questionnaire (total: 0=full understanding, 50=least understanding; consequences: 0=no affect at all, 10=severely affects life; timeline: 0=last very short time, 10=last forever; personal control: 0=no control, 10=extreme control; treatment control : 0=treatment no help, 10=treatment extremely helpful; emotional response: 0=not affected emotionally, 10=extremely affected emotionally); SF-12 (physical component scale: 0=worst physical health, 100=best physical health; mental component scale: 0=worst mental health, 100=best mental health); EQ5D-5L (−0.59=worst health utility, 1.00=best health utility); SPS=Stanford Presenteeism Scale (6=minimum ability, 30=maximum ability); work performance numerical rating scale (0=not affected, 10=unable to do job).
P<0.001.
P=0.01 to <0.05.
P=0.001 to <0.01.
For comparative analysis of categorical variables (derivation of RR), categories that were used to define a positive response coded as 1 (other categories denoting a negative response coded 0) according to preagreed rules for dichotomisation of categorical variables.
RR was derived using completely/much/somewhat better as positive response since the number of people who were completely or much better at two weeks in the BCT group was zero and could not be analysed.