About this trial
This planned randomized controlled trial will enroll 164 patients undergoing hemodialysis to compare the effectiveness of leg massage versus vibration therapy on muscle cramps and patient comfort. Participants will be randomly assigned to one of three groups: a massage group receiving 20-minute lower extremity massage sessions, a vibration group receiving 10-minute vibration therapy, or a control group receiving standard care only. All interventions will be administered three times per week for two weeks (six sessions). The study will evaluate cramp frequency, cramp severity using a Visual Analog Scale, sleep quality through the Pittsburgh Sleep Quality Index, and patient comfort scores. Both interventions are expected to significantly reduce cramp frequency and severity compared to standard care, with massage anticipated to show superior benefits for sleep quality and home-based cramp reduction, while vibration is expected to provide better immediate comfort during dialysis sessions. No serious adverse events are predicted. The findings will help healthcare providers offer personalized, evidence-based non-pharmacological options to improve quality of life for hemodialysis patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients on maintenance HD for ≥3 months who experienced lower extremity muscle cramps.
Disqualifiers
Exclusion criteria included acute illness, lower extremity wounds/infections, deep vein thrombosis, severe neuropathy, and cognitive impairment. All participants provided written informed consent.
Trial design
Parallel
Treatments tested in this trial
massage
Other interventionReceived a standardized 20-minute lower extremity massage (effleurage, petrissage, friction, tapotement) during each HD session, 3x/week for 2 weeks (6 sessions), administered by trained nurses (19).
vibration
Other interventionReceived 10 minutes of mechanical vibration (30-50 Hz, 2-4 mm amplitude) applied to the calf, tibialis anterior, and quadriceps muscles via a portable device during each HD session (20).
Treatment groups
Trial outcomes
Primary outcomes
primary
• Primary: Cramp frequency (episodes/week during HD and at home via daily diary) and cramp severity (10-cm Visual Analog Scale \[VAS\]) (21).
Locations
Sponsors and contacts
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