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Immediate effects of electromassage for pain relief in hemato-oncological patients

Immediate effects of electromassage for pain relief in hemato-oncological patients: a randomized controlled crossover clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4qmbypq
Enrollment
Unknown
Registered
2025-08-20
Start date
2025-08-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Pain

Interventions

This is a randomized, controlled, blinded, crossover study with patients with hematologic cancer undergoing treatment at the Oncology and Hematology Unit of the Hospital de Clínicas Complex of the Fed
E02.331.800
E02.190.599.750.750
E02.779

Sponsors

Universidade Federal do Paraná
Lead Sponsor
Universidade Federal do Paraná
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients of both sexes diagnosed with hematologic cancer (leukemia, lymphoma, or multiple myeloma) undergoing active treatment (chemotherapy, immunotherapy, or radiotherapy); aged between 18 and 60 years; patients experiencing pain resulting from the tumor itself, from cancer treatment, or associated with the tumor (e.g., being bedridden or performing daily activities), regardless of location, with intensity greater than or equal to 4 on the Visual Analogue Scale, within the previous 24 hours; patients with the ability to verbally communicate in Portuguese; patients capable of providing informed consent; patients scoring between 0 and 3 on the ECOG-PS (Eastern Cooperative Oncology Group Performance Status).

Exclusion criteria

Exclusion criteria: Illiterate individuals; patients with psychiatric or cognitive disorders as determined by the opinion and/or follow-up of the attending psychologist; patients with hearing impairments that prevent comprehension of verbal instructions; pregnant or breastfeeding women; patients experiencing pain not directly or indirectly related to the tumor (i.e., chronic low back pain or pain resulting from musculoskeletal diagnoses such as arthritis or arthrosis); patients receiving other analgesic therapies such as radiation, bone cement, or nerve block therapy; individuals with known contraindications to massage therapy, including spinal tumors, known hematologic coagulation disorders (such as hemophilia, Von Willebrand disease, or thrombocytopenia), paresthesia, injuries (open wounds), post-surgical regions, catheters, and deep vein thrombosis (DVT); individuals with known contraindications to electrical stimulation, such as metallic electronic implants like pacemakers or metal at the electrode site, implanted neuromodulation devices, individuals with epilepsy or arrhythmia, dermatological conditions or fragile skin at the application site, and history of allergy to electrodes; use of analgesic or opioid medication during the intervention and data collection period (2 hours), outside of the patient’s regular prescription.

Design outcomes

Primary

MeasureTime frame
Pain reduction of 20% on the Visual Analogue Scale and 30% on the Brief Pain Inventory (BPI) scale, immediately after application, with a 1-hour follow-up

Secondary

MeasureTime frame
Change of 3 points or more in Fatigue Cancer-related fatigue, through the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), immediately after application, with a 1-hour follow-up;Change of 2 points or more in episodes of nausea, vomiting, muscle tension, stress and anxiety, through the 11-point numerical scale, immediately after application, with a 1-hour follow-up;20% reduction in analgesic and opioid consumption, recorded through patient diary and protocols, immediately after application, with a 1-hour follow-up;2-point reduction in the Satisfaction Scale, measured through the Patient Global Impression of Change (PGI-C), immediately after application, with a 1-hour follow-up 1 hour

Countries

Brazil

Contacts

Public ContactRaciele Korelo

Universidade Federal do Paraná

raciele@ufpr.br+55 (41) 99177-6161

Outcome results

None listed

Source: REBEC (via WHO ICTRP)