gms | German Medical Science

Background/research question: Postoperative edema, e.g. after knee surgery, negatively impacts wound healing, mobility and patients’ wellbeing. Decongestive measures consist of manual lymphatic drainage and compression (MLD), though kinesiotaping gains popularity. The technique has been developed by K. Kase, a Japanese chiropractor, based on the conception that taping with elastic material lifts the skin, thereby manipulating the soft tissue similar to massaging especially during movement.

A recent systematic review by Hörmann et al. (currently under review) identified only ten prospective controlled trials on the efficacy of kinesiotaping in the treatment of postoperative edema. Methodological flaws limit evidence from these studies that yield conflicting results.

Methods: We aimed at developing an RCT having the potential to provide more robust evidence taking into account the insights from the systematic review: We try to avoid the flaws observed(+) and to copy the strengths(++).

Results: Population: Patients after knee joint replacement. We choose a homogeneous group (++), although this limits the generalizability to other patient groups.

• Intervention: Kinesiotape.
• Comparator: 1) Manual lymphatic drainage as current standard(+) 2) Sham taping with non-elastic but otherwise equivalent tape(+). So far only one study used – an unconvincing – sham approach.
• Outcome: Primary endpoint of the study is the change in leg circumference at knee-level, similar to existing studies(++), and as an objective measure of morbidity and patient relevant aspect. We hesitate to use a PROM as primary outcome, as patients’ perception may be dominated by surgery. The change refers to measurements at day 1 and day 8, avoiding the use of multiple time points(+). The choice of day 8 is supported by the results of the systematic review. The leg circumference will be measured by a blinded assessor (in triplicates at the joint line, 5 cm proximal and distal), avoiding bias(+) and decreasing the measurement error(+).
• Secondary outcomes include pain(++), range of motion(++), EQ5D(+), KOOS(+), costs(+) and long term assessments after 6 and 12 weeks.
• Design: The huge variation in treatment effects observed and the short term nature of the outcome suggests a group sequential design. One study matching in the main characteristics allowed informing the sample size calculation (n=198).

Conclusion: Considering the strengths and flaws of existing studies identified in a systematic review helped designing a study providing more robust evidence.

Competing interests: none