60
Influence of device appearance on plantar fascia
thickness
50
40
There was no statistically significant interaction ef-
fect between group and time (p = 0.402) for plantar
fascia thickness. There was a significant time effect
(p < 0.001); i.e. a significant decrease from baseline
assessment in all 3 groups. There were no significant
differences between groups (main effect) (p = 0.800)
(Fig. 7).
30
20
10
0
Basal
Group I- Standard device
1 month
2 months
4 months
Time
Group II- Sophisticated Device
14 months
Group III- Austere device
Fig. 4. Foot Function Index (FFI) over time, by device group. Time
factor p < 0.001; device factor p=0.863; device-time interaction factor
p = 0.611. **The whole analysis was adjusted, correcting for age and
sex of the patients, by means of a co-variance analysis (ANCOVA).
The adjustment showed no change in significance with respect to the
initial result.
In this clinical trial there was no loss to follow-up
after the first, second and fourth months after inter-
vention, but there were 7 patients lost to follow-up
after the 14 th month due to lack of interest or time
constraints; hence 128 patients completed the study
and were analysed.
Influence of device appearance on foot function
The data showed no significant interaction effect be
tween treatment group and time for the FFI variable
(F (6.857, 428.554) = 0.064; p = 0.863). However, there was a
significant time effect (F (3.428, 428.554) =209.31; p < 0.001);
that is, a significant decrease from baseline in all 3
groups. No significant differences were found among
groups (main effect) (F (2,125) =0.196; p = 0.611). (Fig. 4).
Influence of device appearance on pain with the first
weight-bearing step in the morning
For the VAS variable there was no significant inte-
raction effect between group and time (p = 0.910).
There was a significant time effect (p < 0.001), with a
significant decrease from baseline assessment in all 3
groups. No significant differences were found among
groups (main effect) (p = 0.623) (Fig. 5).
Influence of device appearance on adverse effects
No serious side-effects or complications were observed
in any group. Adverse effects were increased heel pain
in 19 patients and headache in 9 patients. These effects
appeared after application of rESWT and resolved
completely in 4 days without requiring treatment. No
other adverse events were observed and no significant
differences were found among groups (p = 0.473).
Regarding the discomfort perceived by patients during
the application of rESWT, there were no significant
differences between groups (p = 0.660).
DISCUSSION
Broadly, the placebo and nocebo effects consist of an
improvement or worsening of symptoms that is attribu-
table to the context of the patient-therapist relationship.
10.00
9.00
8.00
7.00
6.00
5.00
4.00
3.00
2.00
1.00
0.00
Influence of device appearance on pain during the day
205
significant decrease from baseline assessment in all 3
groups. No significant differences were found among
groups (main effect) (p = 0.599) (Fig. 6).
70
Comparison of 3 devices on clinical outcomes in plantar fasciitis
For the VAS variable there was no significant inte-
raction effect between group and time (p = 0.853).
There was a significant time effect (p < 0.001), with a
Basal
Group I- Standard device
1 month
2 months
4 months
Time
Group II- Sophisticated Device
14 months
Group III- Austere device
Fig. 5. Visual analogue scale (VAS) assessment of pain with the first
weight-bearing step in the morning, over time and by device group.
Time factor p < 0.001; device factor p = 0.910; device–time interaction
factor p = 0.623.
J Rehabil Med 51, 2019