Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Catherine Sullivan, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT01944280
First received: September 12, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Other: massage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: September 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: massage
No Intervention: control
usual care

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944280

Locations
United States, Ohio
Centers For Dialysis Care
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Catherine Sullivan
Investigators
Principal Investigator: Ashwini Sehgal, MD Case Western Reserve University
  More Information

No publications provided

Responsible Party: Catherine Sullivan, Center Manager, Research, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01944280     History of Changes
Other Study ID Numbers: IRB12-00843
Study First Received: September 12, 2013
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014