Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients

NCT ID: NCT01944280

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention

The intervention group will receive a 20 minute massage during each hemodialysis treatment for 2 weeks. Most patients receive dialysis 3 times per week resulting in 6 massage sessions. The massage will include both feet and legs up to and including the knee. Massage will include general light centripetal friction and point compression to bellies and myotendinous junction of muscles of the foot and calf not to exceed a perceived pain of 6 on a scale of 1 to 10, 10 being most severe and 1 being no pain.

Group Type: EXPERIMENTAL

massage

Intervention Type: OTHER

control

usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

massage

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catherine Sullivan

OTHER

Sponsor Role: lead

Responsible Party

Catherine Sullivan

Center Manager, Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ashwini Sehgal, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Centers For Dialysis Care

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

IRB12-00843

Identifier Type: -

Identifier Source: org_study_id