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Table 5 Summary of outcome measures and healthcare utilisation at 12 weeks by treatment arm

From: Self-management advice, exercise and foot orthoses for plantar heel pain: the TREADON pilot and feasibility randomised trial

Key characteristics Total sample (n = 55†) SMA (n = 7) SMA-exercises (n = 15) SMA-orthoses (n = 18) SMA-combined (n = 15)
Clinical characteristics
Average Pain NRS (last 7 days)a,c 3 (2, 4)1 5 (3, 7) 3 (2, 4) 3 (2, 4) 2 (1, 4)1
Pain on getting out of beda 4 (2, 7)2 6 (3, 9) 4 (3, 6)1 5 (2, 7)1 2 (1, 9)
Heel pain todayb 36 (65.5) 4 (57.1) 11 (73.3) 13 (72.2) 8 (53.3)
Heel(s) affectedb
 Left 13 (28.3)9 3 (42.9) 3 (25.0)3 6 (35.3)1 1 (10.0)5
 Right 18 (39.1)9 2 (28.6) 5 (41.7)3 6 (35.3)1 5 (50.0)5
 Both 15 (32.6)9 2 (28.6) 4 (33.3)3 6 (35.3)1 4 (40.0)5
Ache or pain lasting one day or longer in past monthb 36 (69.2)3 6 (85.7) 11 (78.6)1 12 (70.6)1 7 (50.0)1
FFI-Paina,d 28 (15, 50)14 38 (31, 74)1 24 (16, 48)7 36 (20, 51)4 18 (6, 24)2
FFI-Disabilitya 12 (1, 35)3 19 (12, 67) 17 (7, 48)1 7 (0, 32)2 1 (0, 13)
FFI-Activity Restrictiona 1 (0, 3)1 2 (0, 18) 2 (0, 2)1 2 (0, 4) 0 (0, 1)
FFI-Overalla 37 (21, 80)17 52 (45, 164)1 40 (27, 95)8 40 (26, 82)6 21 (8, 36)2
MFPDI-Functiona 16 (13, 20) 14 (13, 21) 16 (12, 20) 16 (14, 21) 14 (10, 19)
MFPDI-Paina,e 12 (10, 14) 12 (9, 16) 13 (10, 15) 12 (10, 14) 10 (9, 12)
MFPDI-Personal Appearancea 3 (2, 4)19 2 (2, 3)1 3 (2, 4)5 4 (3, 4)6 2 (2, 3)7
MFPDI-Overalla 29 (23, 38)19 29 (25, 32)1 34 (26, 36)5 36 (27, 39)6 23 (22, 28)7
EuroQol EQ5Da .74 (.65, .84)4 .63 (.51, .84)1 .74 (.72, .80) .74 (.64, .84)2 .84 (.71, 1.00)1
Global change, n (%)
 Completely recovered 4 (7) 0 (0) 1 (7) 0 (0) 3 (20)
 Much better 19 (35) 0 (0) 4 (27) 9 (50) 6 (40)
 Better 20 (36) 4 (57) 8 (53) 6 (33) 2 (13)
 No change 9 (16) 2 (29) 2 (13) 3 (17) 2 (13)
 Worse 2 (4) 0 (0) 0 (0) 0 (0) 2 (13)
 Much worse 1 (2) 1 (14) 0 (0) 0 (0) 0 (0)
Healthcare utilisation (other than study intervention)
Additional health provider visits
 Attended an NHS/private health care provider for heel pain, n (%) #1 9 (16) 1 (14) 3 (20) 2 (11) 3 (20)
 GP (NHS), visit count 7 2 3 0 2
 Physiotherapist (NHS/Private), visit count 15/2 1/0 9/0 1/0 4/2
 Podiatrist or Chiropodist (NHS/Private), visit count 5/1 0/0 0/1 2/0 3/0
 Sub-Cost (GBP) total (overall mean) £877.24 (£15.95) £100.88 (£14.41) £379.80 (£25.32) £80.64 (£4.48) £315.92 (£21.06)
Investigations and surgery
 Received an investigation or treatment for heel pain, n (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
 Referred for surgery for heel pain, n (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
 Had surgery for heel pain, n (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
 Had inpatient stay for heel pain, n (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Medications—prescriptions
 Prescribed tablet medication for heel pain, n (%) # #2 3 (5) 0 (0) 2 (13) 0 (0) 1 (7)
 Ibuprofen (Nurofen, Brufen), n 1 0 1 0 0
 Codeine, n 1 0 1 0 0
 Cocodamol (Solpadol, Kapake), n 1 0 0 0 1
 Sub-Cost (GBP) total (overall mean) £9.78 (£0.18) £0 £5.81 (£0.39) £0 £3.97 (£0.26)
Medications–over-the-counter (OTC)
 Bought over-the-counter medication, n (%) #3 15 (27) 4 (57) 3 (20) 5 (28) 3 (20)
 Paracetamol, n 6 (mean cost, £3.81) 2 1 2 1
 Ibuprofen, n 9 (mean cost, £6.37) 3 2 3 1
 Co-codamol, n 1# 0 0 0 1
 Creams/gels/sprays, n 3 (mean cost, £2.98) 2 0 0 1
 Sub-Cost (GBP) total (overall mean) £93.10 (£1.69) £32.69(£4.67) £16.55 (£1.10) £26.73 (£1.49) £17.13 (£1.14)
Indirect (lost productivity)
 No. having time off work (absenteeism), n (days) #4 1 (4) 0 (0) 1 (4) 0 (0) 0 (0)
 Sub-cost (GBP) total (overall mean) £375.42 (£6.83) £0 (£0) £375.42(£25.03) £0 (£0) £0 (£0)
 Work performance (presenteeism) score, mean (SD) #5 1.9 (2.6) 2.3# (3.9) 2.1 (2.0) 2.5 (3.0) 0.6 (1.8)
 Sub-cost (GBP) total (overall mean) £5817.16 (£105.77) £1205.41 (£172.20) £1678.96 (£111.93) £1657.43 (£92.08) £904.06 (£60.27)
Comparison of aggregated mean costs (GBP)
 Direct healthcare cost (NHS + OTC) £82.42 £19.08 £92.67 £70.92 £115.51
 Societal cost
 Healthcare + Work-absenteeism £89.25 £19.08 £117.70 £70.92 £115.51
 Healthcare + absenteeism + presenteeism £195.02 £191.28 £229.63 £163.00 £175.78
  1. #1 Unit cost sources (per visit): GP (£37), allied health professionals band 6 (£26.88 per 30–45 minute-consultation) (private costed as NHS due to lack of available source data on private unit costs)) [38]. #2 Prescription cost ibuprofen 200mg 48 tabs (£1.84), codeine phosphate/co-codamol 30 mg/100 mg 100 tabs (£3.97) [39] #3 Self-reported OTC costs; ^co-codamol cost was not recorded (hence taken to be the same as prescription cost). #4 one person reported taking time off work for heel pain; occupation aligned to SOC2010 code 8111 indicating mean hourly wage £11.14 (mean weekly hours worked 42.1); hence 33.7 hours absence assumed over 4 days; cost £375.42 [40]. #5 Mean hourly wage across all employees in 2017 was £16.16 and mean hours worked was 33.3. Presenteeism costs were extrapolated: number of baseline employees x (average of baseline and follow-up work performance scores)/10 x 33.3 x 16.16.
  2. aMedian (interquartile range)
  3. bAs number (percent) 1–19 Number noted after summary statistics relate to the number of missing/ambiguous data (no number denotes complete 55 responses). For the multi-item measures item-completion numbers, the count × completed-items summary were: FFI-Pain (1 × 0, 1 × 1, 1 × 3, 1 × 6, 9 × 7, 1 × 8, 41 × 9); FFI-Disability (1 × 7, 2 × 8, 52 × 9); FFI-Activity Restriction (1 × 4, 54 × 5); MFPDI-Function (55 × 10); MFPDI-Pain (55 × 7); MFPDI-Personal Appearance (8 × 0, 11 × 1, 36 × 2).
  4. cFor NRS-Pain, mean (SD) values were: SMA, mean = 5.3 (SD 2.5); SMA + E, mean = 2.9 (SD 1.3); SMA + O, mean = 3.2 (SD 2.3); SMA + C, mean = 2.7 (SD = 3.0). The weighted average SD = 2.3 (1-sided 80%CIUL = 2.5; 1-sided 90%CIUL = 2.7; 1-sided 95%CIUL = 2.8)
  5. dFor FFI-Pain, mean (SD) values were SMA, mean = 48.3 (SD 27.6); SMA-exercises, mean = 29.6 (SD 16.5); SMA-orthoses, mean = 35.0 (SD 21.4); SMA-combined, mean = 25.2 (SD = 27.1). The weighted average SD = 23.5 (1-sided 80%CIUL = 26.2; 1-sided 90%CIUL = 27.6; 1-sided 95%CIUL = 28.9)
  6. eFor MFPDI-Pain, mean (SD) values were SMA, mean = 12.7 (SD 4.0); SMA-exercises, mean = 12.6 (SD 3.5); SMA-orthoses, mean = 12.5 (SD 2.9); SMA-combined, mean = 11.6 (SD = 4.2). Weighted average SD = 3.6 (1-sided 80%CIUL = 3.9; 1-sided 90%CIUL = 4.1; 1-sided 95%CIUL = 4.3)
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Pilot and Feasibility Studies

ISSN: 2055-5784

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