gms | German Medical Science

Objective: Hand oedema after injury or surgery is commonly encountered by hand therapists. Whilst being part of the healing process if left untreated or poorly treated it can lead to significant and long term functional difficulties. There is a lack of high quality evidence to support interventions to reduce oedema. This study aimed to assess the trial methods, patient adherence, and inform a definitive trial.

Materials and Methods: A pilot randomized controlled trial was conducted which aimed to recruit 100 participants over 6-months. Compression, elevation and massage (treatment as usual) was compared to kinesiology tape, elevation and massage (trial treatment). The primary efficacy measure was hand volume assessed with a volumeter prior to treatment and 4 and 12 weeks by a blinded assessor. Secondary outcomes included a patient-rated oedema severity scale, function and quality of life. A treatment acceptability questionnaire was completed with participants after their final assessment. Health resource use was also collected. A general linear model was used to estimate the treatment effect.

Results: 26 patients were recruited with a range of digit, hand and wrist injuries. Complete data for 4 and 12 weeks follow-up was obtained on 14 participants. Four participants reported adverse effects. Trial treatment showed a greater improvement in hand volume, function and quality of life scores, however no statistically significant difference between groups for any outcome measure was found. Adherence ranged from 39% to 100%. Higher levels of adherence and patient acceptability were seen in the treatment as usual group.

Conclusions: This pilot trial highlights challenges with regards to recruitment and retention of patients over a 12 week trial period, treatment fidelity, and the practicalities of conducting a trial in a busy clinical department which will need to be addressed before a definitive trial.