Massage of the Trapezius Muscle and Foot in Fibromyalgia Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Massage Therapy

Intervention / Treatment
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* Other: Trapezius Massage
* Other: Foot Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are ≥18 years of age, are diagnosed with fibromyalgia according to ACR 2010 diagnostic criteria, have a VAS Pain score of ≥ 5, have no obstacles for receiving massage (advanced stage COPD, asthma, heart or kidney failure, malignant conditions, febrile diseases, pregnancy), have no problems (rash, lesion, temperature increase, swelling, waist and neck herniation, oedema, bone anomalies, localized infections) in the massage application area have not used any analgesics within the last 24 hours have not received physiotherapy within the last 6 months have no communication problems are willing to participate in the study Exclusion Criteria: are planned to receive physiotherapy during the research changing pharmacological treatment have undesired effects in the massage area during the application (skin bruising, etc.) wish to withdraw

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trapezius Massage Group<br>A patient information form will be given to each patient and the pre-test Pain Scale, Revise Fibromyalgia Impact Questionnaire and SF36 quality of life scale will be filled face-to-face. The patients inTrapezius Massage Group 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. Patients in Trapezius Massage Group 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 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 Trapezius Massage Group at the end of 6 weeks (post-test) | Other: Trapezius Massage<br>* The patients in Trapezius Massage Group 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.<br>|
| Experimental: Foot Massage Group<br>A patient information form will be given to each patient and the pre-test Pain Scale, Revise Fibromyalgia Impact Questionnaire and SF36 quality of life scale will be filled face-to-face. The patients in Foot Massage Group 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 Foot Massage Group will be called weekly by phone throughout the study and pain will be questioned with VAS. Pain follow-up of the patients in Foot Massage Group 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 Foot Massage Group Group at the end of 6 weeks (post-test) | Other: Foot Massage<br>* The patients in Foot Massage Group will be given foot massage for 6 weeks, 2 sessions per week (12 sessions in total) by the researcher in the physical therapy unit.<br>|
| No Intervention: Control Group<br>A patient information form will be given to each patient and the pre-test Pain Scale, Revise Fibromyalgia Impact Questionnaire and SF36 quality of life scale will be filled face-to-face. Patients in Control Group will not receive massage. Patients in Control Group will be called weekly by phone throughout the study and pain will be questioned with VAS. Pain Scale, Fibromyalgia Impact Questionnaire and SF36 Quality of Life Scale will be administered face-to-face to the patients in Control Group at the end of 6 weeks (post-test) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised Fibromyalgia Impact Questionnaire | The scale, which evaluates the effect of fibromyalgia during the last week, consists of 3 sub-dimensions: function (9 items), general effect (2 items) and symptom (10 items) and a total of 21 questions. Scale questions are scored between 0 and 10 points, with 10 indicating the worst possible situation. The total score for the function sub-dimension (between 0 and 90) is divided by 3, the total score for the impact sub-dimension (between 0 and 20) is not divided, and the total score for the symptom sub-dimension (between 0 to 100) is divided by 2 and sub-dimension scores are obtained. The function sub-dimension of the scale ranges between 0 and 30, the impact sub-dimension ranges between 0 and 20, and the symptom sub-dimension ranges between 0 and 50 points. The total scale score is obtained by adding the sub-dimensions, and it is between 0-100; higher scores indicate higher effect of fibromyalgia | six week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 Quality of Life Scale | The scale, which is widely used to evaluate the quality of life, includes 36 items and 8 dimensions (physical function, social function, pain, energy, emotional role limitation, physical role limitation, mental health and general perception of health). Each dimension score ranges between 0 and 100. Higher scores indicate higher quality of life. | six week | 
| Visual Analog Scale (VAS)-Pain | Visual Analogue Scale (VAS 0-10) is a straight line used to measure the variability of pain, showing the continuity of pain. There is no pain (0) on one end of this line, and most severe pain (10) on the other end. The intensity of pain is marked on this line. The value found by measuring the place marked on the 10 cm long line with a ruler determines the pain. | six week |