Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944280
• Other study ID #: IRB12-00843
• Status: Completed
• Phase: N/A
• First received: September 12, 2013
• Last updated: October 2, 2015
• Start date: September 2013

Study information

• Verified date: October 2015
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• massage

Locations

Country	Name	City	State
United States	Centers For Dialysis Care	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Catherine Sullivan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No