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Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients

NCT01944280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-10-05

No results posted yet for this study

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.

Conditions

Interventions

OTHER

massage

Sponsors & Collaborators

  • Catherine Sullivan

    lead OTHER

Principal Investigators

  • Ashwini Sehgal, MD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01944280 on ClinicalTrials.gov