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Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
massage
Sponsored by
Catherine Sullivan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centers For Dialysis Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

control

Arm Description

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.

usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2013
Last Updated
October 2, 2015
Sponsor
Catherine Sullivan
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1. Study Identification

Unique Protocol Identification Number
NCT01944280
Brief Title
Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients
Official Title
Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Catherine Sullivan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
massage
Primary Outcome Measure Information:
Title
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwini Sehgal, MD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centers For Dialysis Care
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

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Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients

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