Massage of the Trapezius Muscle and Foot in Fibromyalgia Patients

Massage Therapy Clinical Trial

Official title: Evaluation of the Effects of Classical Massage to Trapezius Muscle and Foot in Fibromyalgia Patients

Status Recruiting

Clinical Trial Summary

Objective: This study will be conducted to evaluate the effects of classical massage applied to the trapezius muscle and foot in patients with fibromyalgia on pain, effects of fibromyalgia and quality of life.

Material and Method: The research will be carried out with 75 patients with fibromyalgia who refer to Artvin State Hospital Physical Therapy and Rehabilitation outpatient clinic. The patients will be grouped in 3 through simple randomization: trapezius massage (Group A), foot massage (Group B) and control group (Group C). In the physical therapy unit, the patients in Group A will receive a total of 12 sessions of trapezius massage, 2 sessions per week for 6 weeks; the patients in Group B will receive a total of 12 sessions of foot massage, 2 sessions per week for 6 weeks and Group C will not receive massage. Patient information form, VAS pain scale, Revised Fibromyalgia Impact Questionnaire and SF 36 Quality of Life Scale will be used to collect data. Chi-square paired t test, Wilcoxon test, one-way analysis of variance and Kruskal Wallis test will be used in the analysis of data.

Clinical Trial Description

Fibromyalgia is a chronic disease characterized by widespread musculoskeletal pain associated with a range of somatic symptoms such as fatigue, sleep disturbance, and somatic and cognitive symptoms.

This study will be conducted to evaluate the effects of classical massage applied to the trapezius muscle and foot in patients with fibromyalgia on pain, effects of fibromyalgia and quality of life.

The research will be carried out with 75 patients with fibromyalgia who refer to Artvin State Hospital Physical Therapy and Rehabilitation outpatient clinic. The patients will be grouped in 3 through simple randomization: trapezius massage (Group A), foot massage (Group B) and control group (Group C). Fibromyalgia patients who are admitted to the Physical Therapy and Rehabilitation outpatient clinic will be met, informed about the research and their written consent will be obtained. Groups of patients who meet the inclusion criteria will be determined according to the randomization list.

A patient information form will be given to each patient and the pre-test Pain Scale, Fibromyalgia Impact Questionnaire and SF36 quality of life scale will be filled face-to-face.

The patients in Group A will be given classical massage to the trapezius muscle for 6 weeks, 2 sessions per week (12 sessions in total) by the researcher in the physical therapy unit.

The patients in Group B will be given foot massage for 6 weeks, 2 sessions per week (12 sessions in total) by the researcher in the physical therapy unit.

Patients in Group C will not receive massage. Patients in all three groups will be called weekly by phone throughout the study and pain will be questioned with VAS.

Pain follow-up of the patients in trapezius massage and foot massage groups will be performed 48 hours after the massage.

Pain Scale, Fibromyalgia Impact Questionnaire and SF36 Quality of Life Scale will be administered face-to-face to the patients in all groups at the end of 6 weeks (post-test). The final test measurements of the participants in trapezius massage and foot massage groups will be made 48 hours after the massage.

Statistical analyses will be performed using the SPSS (IBM SPSS Statistics 23) package program. Shapiro-Wilk or Kolmogorov-Smirnov goodness of fit tests and graphical methods will be used to test whether the distributions of numerical variables conform to the normal distribution. Descriptive statistics such as mean and standard deviation will be given for numerical variables with normal distribution. For numerical variables that do not show normal distribution, descriptive statistics such as median, interquartile distribution range, minimum and maximum will be given. Categorical variables will be presented with frequency and percentage values. Whether there is a difference between categorical variables will be examined by Chi-square (χ2) test. Whether there is a difference in terms of the measurements taken in the three groups and at the two times will be examined by repeated measures two-way ANOVA, if assumptions are met. If the terms interaction are meaningful, we need to examine them separately between groups and within the group. The difference between the groups will be examined with the appropriate ANOVA or Kruskal-Wallis tests. The difference within each group will be examined with the paired-sample t test or Wilcoxon tests, as appropriate. Measurements will be taken for 6 weeks for the VAS score. Whether there is a difference in VAS score within each group will be examined with one-way analysis of variance or Friedman tests, as appropriate.

Statistical significance level will be accepted as p<0.05. ;

Related Conditions & MeSH terms

• Fibromyalgia
• Massage Therapy

• NCT number: NCT05865522
• Study type: Interventional
• Source: Ataturk University
• Contact: Emre ERKAL, PhD Student
• Phone: 543.375.07.09
• Email: emreerkal@hotmail.de
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2023
• Completion date: May 18, 2024