Effects of biophysical stimulation in patients undergoing arthroscopic reconstruction of anterior cruciate ligament: prospective, randomized and double blind study.

Pre-clinical studies have shown that treatment
by pulsed electromagnetic fields (PEMFs) can limit the
catabolic effects of pro-inflammatory cytokines on articular
cartilage and favour the anabolic activity of the
chondrocytes. Anterior cruciate ligament (ACL) reconstruction
is usually performed by arthroscopic procedure
that, even if minimally invasive, may elicit an inflammatory
joint reaction detrimental to articular cartilage. In
this study the effect of I-ONE PEMFs treatment in
patients undergoing ACL reconstruction was investigated.
The study end-points were (1) evaluation of patients’functional recovery by International Knee Documentation
Committee (IKDC) Form; (2) use of non-steroidal antiinflammatory
drugs (NSAIDs), necessary to control joint
pain and inflammation. The study design was prospective,
randomized and double blind. Sixty-nine patients were
included in the study at baseline. Follow-up visits were
scheduled at 30, 60 and 180 days, followed by 2-year
follow-up interview. Patients were evaluated by IKDC
Form and were asked to report on the use of NSAIDs.
Patients were randomized to active or placebo treatments;
active device generated a magnetic field of 1.5 mT at
75 Hz. Patients were instructed to use the stimulator (IONE)
for 4 h per day for 60 days. All patients underwent
ACL reconstruction with use of quadruple hamstrings
semitendinosus and gracilis technique. At baseline there
were no differences in the IKDC scores between the two
groups. At follow-up visits the SF-36 Health Survey score
showed a statistically significant faster recovery in
the group of patients treated with I-ONE stimulator
(P\0.05). NSAIDs use was less frequent among active
patients than controls (P\0.05). Joint swelling resolution
and return to normal range of motion occurred faster in
the active treated group (P\0.05) too. The 2-year follow-
up did not shown statistically significant difference
between the two groups. Furthermore for longitudinal
analysis the generalized linear mixed effects model was
applied to calculate the group 9 time interaction coefficient;
this interaction showed a significant difference
(P\0.0001) between the active and placebo groups for
all investigated variables: SF-36 Health Survey, IKDC
Subjective Knee Evaluation and VAS. Twenty-nine
patients (15 in the active group; 14 in the placebo group)
underwent both ACL reconstruction and meniscectomy;
when they were analysed separately the differences in SF-
36 Health Survey scores between the two groups were larger then what observed in the whole study group
(P\0.05). The results of this study show that patient’s
functional recovery occurs earlier in the active group. No
side effects were observed and the treatment was well
tolerated. The use of I-ONE should always be considered
after ACL reconstruction, particularly in professional
athletes, to shorten the recovery time, to limit joint
inflammatory reaction and its catabolic effects on articular
cartilage and ultimately for joint preservation.