Massage of the Trapezius Muscle and Foot in Fibromyalgia Patients
Study Details
Study Description
Brief 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 72 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed 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 72 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.
Research data will be evaluated by using the SPSS package program. The data obtained will be shown with numbers, percentages, standard deviations and mean. It will be evaluated whether the data meet the normal distribution conditions to decide on the tests to be used.
Chi-square, One-Way Analysis of Variance and Kruskal-Wallis test will be used to compare patient characteristics in terms of groups. In intragroup comparisons of trapezius muscle massage, foot massage and control groups, paired t test will be used when normal distribution conditions are met, and Wilcoxon test will be used when normal conditions are not met. In intergroup comparisons of trapezius muscle massage, foot massage and control groups, one-way analysis of variance (ANOVA) will be used when normal distribution conditions are met, and Kruskall Wallis test will be used when normal conditions are not met. Statistical significance level will be taken as 5% in all statistical calculations.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Trapezius Massage Group 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
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.
|
| Experimental: Foot Massage Group 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
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.
|
| No Intervention: Control Group 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 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 Control Group at the end of 6 weeks (post-test) |
Outcome Measures
Primary Outcome Measures
- Visual Analog Scale (VAS)-Pain [six week]
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.
Secondary Outcome Measures
- Revised Fibromyalgia Impact Questionnaire [six week]
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
- SF-36 Quality of Life Scale [six week]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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are ≥18 years of age,
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are diagnosed with fibromyalgia according to ACR 2010 diagnostic criteria,
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have a VAS Pain score of ≥ 5,
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have no obstacles for receiving massage (advanced stage COPD, asthma, heart or kidney failure, malignant conditions, febrile diseases, non-pregnancy),
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have no problems (rash, lesion, temperature increase, swelling, waist and neck herniation, oedema, bone anomalies, localized infections) in the massage application area
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have not used any analgesics within the last 24 hours
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have not received physiotherapy within the last 6 months
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have no communication problems
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are willing to participate in the study
Exclusion Criteria:
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are planned to receive physiotherapy during the research
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have undesired effects in the massage area during the application (skin bruising, etc.)
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wish to withdraw
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Artvin State Hospital Physical Therapy and Rehabilitation outpatient clinic | Artvin | Turkey | 08000 |
Sponsors and Collaborators
- Emre Erkal
Investigators
- Study Director: Emine Kiyak, PhD, Ataturk University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EmreTez