Effects of Massage Therapy on Peripheral Neuropathy and Quality of Life

NCT ID: NCT05433246

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-01
• Study Completion Date: 2013-05-01

Brief Summary

The aim of this randomized controlled experimental study was to determine the effect of massage applied to colorectal cancer patients receiving chemotherapy on peripheral neuropathy and quality of life.

Detailed Description

The aim of this randomized controlled experimental study was to determine the effect of massage applied to colorectal cancer patients receiving chemotherapy on peripheral neuropathy and quality of life.Investigation was carried out between February 2012- May 2013 with 52 patients meeting study criteria and receiving chemotherapy in Akdeniz University outpatient chemotherapy unit (28 study group, 24 control).

Massage therapy group:The experimental group patients were given a series of effleurage, petrissage and surface fraction types of classical massage on local parts of they're body-below, elbow-frontal arm-hand (20 minutes) and below knee-leg (lower part)-foot (20 minutes) two days of treatment of 16 times total.The patients in the massage group received 16 sessions of classical massage performed by the research nurse, who had classical massage training and certification.Baseline, patient characteristics , peripheral neuropathy symptoms, neuropathic pain, cancer and chemotherapy-related symptoms, and quality of life were completed. Peripheral neuropathy symptoms, cancer, and chemotherapy-related symptoms were assessed at each cycle (2th, 4th, 6th, 8th,10th,12th,14th, 16th. week- (two-week intervals)). Neuropathic pain and quality of life were measured at 4, 10, and 16 weeks. At week 16 (2 weeks after the intervention), the grade of peripheral sensory neuropathy was determined.

Control Group: The patients received routine care. Baseline, patient characteristics , peripheral neuropathy symptoms, neuropathic pain, cancer and chemotherapy-related symptoms, and quality of life were completed. Peripheral neuropathy symptoms, cancer, and chemotherapy-related symptoms were assessed at each cycle (2th, 4th, 6th, 8th,10th,12th,14th, 16th. week (two-week intervals)). Neuropathic pain and quality of life were measured at 4, 10, and 16 weeks. At week 16 (2 weeks after the intervention), the grade of peripheral sensory neuropathy was determined.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

The patients received routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Massage therapy group

The patients in the massage group were given classical massage for 2 consecutive days in each chemotherapy cycle (with an interval of two weeks). Massage therapy was performed with a classical massage technique using effleurage, petrissage, and superficial friction techniques for a total of 40 minutes on the areas below the elbow-forearm-hand (20 minutes), and below the knee-lower leg-foot (20 minutes). The patients in the massage group received 16 sessions of classical massage performed by the research nurse, who had classical massage training and certification.

Group Type: EXPERIMENTAL

Massage therapy group

Intervention Type: BEHAVIORAL

Massage therapy was performed with a classical massage technique using effleurage, petrissage, and superficial friction techniques for a total of 40 minutes on the areas below the elbow-forearm-hand (20 minutes), and below the knee-lower leg-foot (20 minutes). The patients in the massage group received 16 sessions of classical massage performed by the research nurse, who had classical massage training and certification.

Interventions

Massage therapy group

Massage therapy was performed with a classical massage technique using effleurage, petrissage, and superficial friction techniques for a total of 40 minutes on the areas below the elbow-forearm-hand (20 minutes), and below the knee-lower leg-foot (20 minutes). The patients in the massage group received 16 sessions of classical massage performed by the research nurse, who had classical massage training and certification.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• over 18 years old
• have a diagnosis of colorectal cancer
• receiving FOLFOX-4 chemotherapy protocol
• to receive a maximum of 4 cycles of FOLFOX-4 chemotherapy
• platelet values over -100.000/mm3
• no obstacle to massage application

Exclusion Criteria

• previously been diagnosed with polyneuropathy,
• has been diagnosed with diabetes,
• is addicted to alcohol,
• has been amputated at the extremities,
• has a skin infection and skin integrity disorder,
• has megaloblastic anemia, uses anticoagulants,
• takes drugs that hide or affect neuropathy findings
• has had massage therapy within the last month.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fatma Arikan

OTHER

Sponsor Role: lead

Responsible Party

Fatma Arikan

Assistant Professor, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Feray Gökdogan, PhD, RN

Role: STUDY_CHAIR

Cyprus International University

Other Identifiers

2011/211

Identifier Type: -

Identifier Source: org_study_id