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Table 1 Participant baseline characteristics by intervention arm and by recruitment method

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

Key characteristics Total sample n = 82 Treatment groups Recruitment method
SMA n = 11 SMA-exercises n = 23 SMA-orthoses n = 24 SMA-combined n = 24 GP consultation n = 37 Medical record review n = 22 Population survey n = 23
Non-clinical characteristics
 Agea 55 (48, 67)4 56 (39, 60) 54 (51, 65) 54 (49, 70)4 55 (47, 67) 54 (47, 67)2 55 (49, 57)1 60 (48, 69)1
 Gender – malesb 36 (43.9) 5 (45.5) 11 (47.8) 10 (41.7) 10 (41.7) 14 (37.8) 8 (36.4) 14 (60.9)
 Employedb 47 (58.0)1 7 (63.6) 12 (54.6)1 14 (58.3) 14 (58.3) 24 (64.9) 12 (57.1)1 11 (47.8)
 White UK/European ethnicityb,e 40 (88.9) 8 (88.9) 11 (91.7) 9 (100) 12 (80.0) – 21 (95.5) 19 (82.6)
 Effect of pain on work performancea,c 2 (0, 6) 6 (0, 7) 3 (0, 6) 1 (0, 4) 0 (0, 2) 1 (0, 5) 2 (0, 7) 2 (0, 3)
 Time off work past 6 monthsb,c 4 (8.5) 1 (14.3) 1 (8.3) 0 (0.0) 2 (14.3) 3 (12.5) 1 (8.3) 0 (0)
Clinical characteristics
 Average pain NRS (last 7 days)a,f 6 (4, 7)2 6 (4, 7) 5 (4, 6)1 7 (5, 8) 6 (5, 7)1 7 (6, 8) 6 (4, 7) 5 (4, 6)2
 Pain on getting out of beda 7 (5, 9)2 7 (5, 8) 7 (5, 8)1 8 (7, 10) 7 (5, 8)1 8 (7, 9) 6 (5, 8) 6 (5, 7)2
 First time heel painb 46 (58.2)3 4 (36.4) 15 (65.2) 14 (63.6)2 13 (56.5)1 26 (72.2)1 13 (61.9)1 7 (31.8)1
 Heel pain todayb 74 (90.2) 9 (81.8) 21 (91.3) 22 (91.7) 22 (91.7) 35 (94.6) 18 (81.8) 21 (91.3)
Heel(s) affectedb
 Left 23 (28.8)2 5 (45.5) 7 (31.8)1 7 (30.4)1 4 (16.7) 14 (40.0)2 2 (9.1) 7 (30.4)
 Right 24 (30.0)2 1 (9.1) 7 (31.8)1 8 (34.8)1 8 (33.3) 10 (28.6)2 9 (40.9) 5 (21.7)
 Both 33 (41.3)2 5 (45.5) 8 (36.4)1 8 (34.8)1 12 (50.0) 11 (31.4)2 11 (50.0) 11 (47.8)
Pain durationb
 < 3 months 15 (18.8)2 1 (9.1) 4 (18.2)1 5 (20.8) 5 (21.7)1 14 (38.9)1 0 (0.0)1 1 (4.4)
 3–6 months 22 (27.5)2 2 (18.2) 8 (36.4)1 5 (20.8) 7 (30.4)1 13 (36.1)1 5 (23.8)1 4 (17.4)
 6–12 months 13 (16.3)2 1 (9.1) 4 (18.2)1 5 (20.8) 3 (13.0)1 3 (8.3)1 4 (19.1)1 6 (26.1)
 > 12 months 30 (37.5)2 7 (63.6) 6 (27.3)1 9 (37.5) 8 (34.8)1 6 (16.7)1 12 (57.1)1 12 (52.2)
Ache or pain lasting one day or longer in past monthb 77 (95.1)1 11 (100.0) 21 (95.5)1 23 (95.8) 22 (91.7) 34 (91.9) 22 (100) 21 (95.5)1
FFI-Paina,g 53 (38, 67)37d 58 (44, 69)5 41 (36, 51)7 62 (38, 67)11 56 (53, 61)14 62 (41, 72)17 54 (34, 59)6 40 (34, 45)14
FFI-Disabilitya 43 (18, 57)6 35 (25, 54)1 33 (16, 47)1 48 (20, 58)2 51 (18, 62)2 49 (35, 61)3 28 (5, 58) 27 (15, 49)3
FFI-Activity Restrictiona 3 (0, 7)4 5 (2, 19)1 2 (0, 5)2 4 (0, 7) 3 (0, 5)1 4 (1, 10)1 2 (1, 6)1 2 (0, 5)2
FFI-Overalla 99 (62, 133)38 103 (86, 148)5 69 (58, 111)8 127 (66, 134)11 107 (62, 156)14 124 (75, 153)17 74 (57, 123)6 83 (64, 102)17
MFPDI-Functiona 18 (16, 22)9 19 (5, 24)1 17 (14, 22)4 19 (15, 23)2 20 (17, 22)2 20 (17, 22)1 18 (15, 21)4 16 (14, 23)4
MFPDI-Paina,h 13 (12, 16)4 13 (11, 15)1 13 (11, 14)1 15 (12, 17)2 13 (12, 16) 14 (12, 16)1 15 (11, 17)1 12 (11, 14)2
MFPDI-Personal Appearancea 3 (2, 4)30 4 (3, 5)3 4 (3, 4)9 3 (3, 4)11 3 (2, 3)7 3 (3, 4)14 3 (2, 3)7 3 (2, 4)9
MFPDI-Overalla 36 (31, 40)34 36 (30, 43)3 32 (30, 38)10 37 (33, 40)12 37 (29, 39)9 38 (32, 40)16 35 (33, 39)9 35 (28, 40)9
EQ5Da .69 (.55, .74)4 .68 (.61, .71)1 .74 (.70, .77)1 .64 (.46, .74)2 .69 (.59, .74) .65 (.46, .73)2 .72 (.65, .80)1 .70 (.64, .74)1
  1. aSummarised as median (interquartile range)
  2. bSummarised as number (percentage). 1–38 Numbers noted after summary statistics relate to the number of missing/ambiguous data (no number denotes complete 82 responses to that measure). For the multi-item measures item-completion numbers, the count × completed-items summary was as follows: FFI-Pain (1 × 1, 1 × 3, 4 × 6, 29 × 7, 2 × 8, 45 × 9); FFI-Disability (1 × 0, 1 × 4, 2 × 7, 2 × 8, 76 × 9); FFI-Activity Restriction (3 × 0, 1 × 2, 78 × 5); MFPDI-Function (1 × 1, 1 × 4, 1 × 6, 1 × 7, 2 × 8, 3 × 9, 73 × 10); MFPDI-Pain (1 × 0, 1 × 2, 2 × 5, 78 × 7); MFPDI-personal appearance (15 × 0, 15 × 1, 52 × 2)
  3. camong those answered ‘employed’
  4. dMissing data of FFI-Pain mainly due to non-response of two particular questions ‘When you walk with orthotic devices/insoles’ and ‘When you stand with orthotic devices/insoles’
  5. eEthnicity was assessed in the screening survey but not the baseline questionnaire (and was therefore not available for those identified by GP consultation who completed only the baseline questionnaire). Data were available for 45 participants (SMA 9, SMA-exercises 12, SMA-orthoses 9, SMA-combined 15; GP consultation 0, medical record review 22, population survey 23)
  6. fFor pain NRS, mean (SD) values were as follows: total sample, mean = 5.8 (SD 2.0; 1-sided 80%CIUL = 2.2; 1-sided 90%CIUL = 2.3; 1-sided 95%CIUL = 2.4); SMA, mean = 5.4 (SD 3.0); SMA-exercises, mean = 5.1 (SD 1.6); SMA-orthoses, mean = 6.5 (SD 2.1); SMA-combined, mean = 6.0 (SD = 1.7)
  7. gFor FFI-Pain, mean (SD) values were as follows: Total sample, mean = 50.7 (SD 17.3; 1-sided 80%CIUL = 19.1; 1-sided 90%CIUL = 20.1; 1-sided 95%CIUL = 21.0); SMA, mean = 57.0 (SD 13.6); SMA-exercises, mean = 43.7 (SD 13.4); SMA-orthoses, mean = 55.7 (SD 18.9); SMA-combined, mean = 51.5 (SD = 20.7)
  8. hFor MFPDI-Pain, mean (SD) values were as follows: total sample, mean = 13.7 (SD 2.6; 1-sided 80%CIUL = 2.9; 1-sided 90%CIUL = 3.0; 1-sided 95%CIUL = 3.1); SMA, mean = 13.4 (SD 3.0); SMA-exercises, mean = 13.0 (SD 2.3); SMA-orthoses, mean = 14.5 (SD 2.6); SMA-combined, mean = 13.8 (SD = 2.8)
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Pilot and Feasibility Studies

ISSN: 2055-5784

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