Comparative Study Between Leg Massage and Vibration on Cramps and Comfort for Patients Undergoing Hemodialysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Muscle cramps are one of the most common and distressing complications experienced by patients undergoing hemodialysis, affecting approximately 33% to 86% of this population. These involuntary, painful muscle contractions, predominantly occurring in the lower extremities, often lead to premature termination of dialysis sessions, sleep disturbances, and significant deterioration in quality of life. While pharmacological interventions such as hypertonic saline, glucose, and carnitine supplements are currently used, their effectiveness remains inconsistent and they may carry adverse effects. Consequently, there is a growing interest in non-pharmacological approaches that are safe, cost-effective, and easily integrated into routine dialysis care. Both leg massage and vibration therapy have shown individual promise in managing muscle cramps and improving patient comfort, yet no large-scale randomized controlled trial has directly compared their relative effectiveness. This study will address this critical knowledge gap by providing head-to-head comparative evidence to guide clinical decision-making.
This study will be designed as a prospective, parallel-group, randomized controlled trial conducted across three outpatient hemodialysis centers. A total of 164 adult patients undergoing maintenance hemodialysis for at least three months who experience lower extremity muscle cramps will be enrolled. After providing informed consent, participants will be stratified based on dialysis session frequency, baseline cramp frequency, age, and gender to ensure homogeneity across groups. Using a computer-generated random sequence, patients will be allocated in a 1:1:1 ratio to one of three groups: the massage group (n=61), the vibration group (n=57), or the control group (n=46). Due to the nature of the interventions, blinding of participants and intervention providers will not be feasible; however, outcome assessors and data analysts will remain blinded to group allocation to minimize detection bias.
Participants in the massage group will receive a standardized 20-minute lower extremity massage during each hemodialysis session, administered three times per week for a total of two weeks (six sessions). The massage protocol will include effleurage (gentle stroking), petrissage (kneading), friction (deep circular movements), and tapotement (rhythmic tapping) applied by trained registered nurses with certification in therapeutic massage. The vibration group will receive 10 minutes of mechanical vibration therapy using a portable device delivering vibration at a frequency of 30-50 Hz with an amplitude of 2-4 mm, applied to the posterior calf, anterior tibial, and quadriceps muscles. The control group will receive standard dialysis care without any additional interventions. The primary outcomes will be cramp frequency (recorded via daily patient diaries during dialysis and at home) and cramp severity measured using a 10-cm Visual Analog Scale (VAS). Secondary outcomes will include sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), patient comfort scores during dialysis sessions, and documentation of any adverse events.
It is hypothesized that both massage and vibration interventions will demonstrate significant superiority over standard care in reducing cramp frequency and severity, with each intervention showing distinct advantages in specific outcome domains. Specifically, the massage group is expected to exhibit greater improvement in sleep quality and more substantial reduction in home-based cramping episodes compared to both the vibration and control groups. Conversely, the vibration group is anticipated to achieve higher immediate comfort scores during dialysis sessions, reflecting the shorter intervention duration and potentially greater patient tolerability. Both interventions are predicted to be safe, with no serious adverse events expected. The findings from this trial will provide robust evidence to guide personalized, patient-centered care, enabling healthcare providers to recommend either massage or vibration based on individual patient priorities, clinical presentation, and available resources. Ultimately, integrating these evidence-based non-pharmacological interventions into routine hemodialysis protocols has the potential to substantially improve treatment adherence, patient satisfaction, and overall quality of life for the growing population of patients receiving maintenance hemodialysis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients on maintenance HD for ≥3 months who experienced lower extremity muscle cramps.
Exclusion Criteria:
- Exclusion criteria included acute illness, lower extremity wounds/infections, deep vein thrombosis, severe neuropathy, and cognitive impairment. All participants provided written informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
no intervention
|
|
|
Experimental: study
interventional
|
Received a standardized 20-minute lower extremity massage (effleurage, petrissage, friction, tapotement) during each HD session, 3x/week for 2 weeks (6 sessions), administered by trained nurses (19).
Received 10 minutes of mechanical vibration (30-50 Hz, 2-4 mm amplitude) applied to the calf, tibialis anterior, and quadriceps muscles via a portable device during each HD session (20).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
primary
Time Frame: 2 weeks
|
• Primary: Cramp frequency (episodes/week during HD and at home via daily diary) and cramp severity (10-cm Visual Analog Scale [VAS]) (21).
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Renal Insufficiency, Chronic
- Muscle Cramp
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Mechanical Phenomena
- Physical Phenomena
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Vibration
- Massage
Other Study ID Numbers
- BaghdadUN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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