Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients

NCT01944280 | Completed

• 1 other identifier: IRB12-00843
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

intervention

EXPERIMENTAL

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

control

NO INTERVENTION

usual care

Interventions

massage OTHER

intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catherine Sullivan: lead

Study Sites (1)

Centers For Dialysis Care

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Massage

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ashwini Sehgal, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Center Manager, Research

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

US (1)