End Stage Renal Disease
Conditions
Brief summary
Primary Aim. The primary aim is to determine the effectiveness of intradialytic massage on the frequency and severity of cramping among hemodialysis patients prone to lower extremity cramping during treatment. Hypothesis: Compared to control patients, intervention patients will be significantly less likely to have intradialytic cramping that requires staff intervention or treatment termination. This is a study involving 32 (16 intervention, 16 control) hemodialysis patients with frequent lower extremity cramps during treatment. Frequent cramping during dialysis treatments is defined as 1 or more episodes of lower extremity cramps during or after dialysis over the previous 2 weeks. Cramping frequency will be determined by chart notes. Muscle cramping is defined as contraction of the large muscle group of the lower extremities sufficiently painful to require intervention by the dialysis staff for relief. The intervention group will receive a 20 minute massage of the lower extremities by a trained and licensed massage therapist during each treatment (3x per week) for 2 weeks. The control group will receive usual care by dialysis center staff.
Interventions
OTHERmassage
Sponsors
Catherine Sullivan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* \>18 years of age and \<90 years of age. * On hemodialysis greater than 6 months. * A stable dry weight for the previous month. * Frequent cramping during dialysis treatments defined as 1 or more episodes of lower extremity cramps during or after dialysis over the previous 2 weeks. * Ability to give informed consent.
Exclusion criteria
* Sores or wounds on feet or lower legs. * Dermatitis of lower legs or feet. * Edema greater than 2+. * Known history of Deep Vein Thrombosis. * Vascular access (arteriovenous (A-V) graft, A-V fistula or catheter) for hemodialysis is located in the lower extremity. * Evidence of open leg wounds, history of lower extremity amputation or documented history of peripheral vascular disease. * Acute hemodynamic or clinical instability per the dialysis nurse or tech just prior to the intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim is to determine the effectiveness of intradialytic massage on the frequency and severity of cramping among hemodialysis patients prone to lower extremity cramping during treatment. | 2 weeks |
Countries
United States
Outcome results
None listed