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Massage of the Trapezius Muscle and Foot in Fibromyalgia Patients

Primary Purpose

Massage Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Trapezius Massage
Foot Massage
Sponsored by
Emre Erkal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Massage Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Artvin State Hospital Physical Therapy and Rehabilitation outpatient clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Trapezius Massage Group

Foot Massage Group

Control Group

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
April 25, 2023
Last Updated
September 14, 2023
Sponsor
Emre Erkal
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1. Study Identification

Unique Protocol Identification Number
NCT05865522
Brief Title
Massage of the Trapezius Muscle and Foot in Fibromyalgia Patients
Official Title
Evaluation of the Effects of Classical Massage to Trapezius Muscle and Foot in Fibromyalgia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
May 18, 2024 (Anticipated)
Study Completion Date
May 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emre Erkal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trapezius Massage Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Foot Massage Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Trapezius Massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Foot Massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)-Pain
Description
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.
Time Frame
six week
Secondary Outcome Measure Information:
Title
Revised Fibromyalgia Impact Questionnaire
Description
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
Time Frame
six week
Title
SF-36 Quality of Life Scale
Description
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.
Time Frame
six week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emre ERKAL, PhD Student
Phone
543.375.07.09
Email
emreerkal@hotmail.de
First Name & Middle Initial & Last Name or Official Title & Degree
Emre ERKAL, PhD Student
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine Kiyak, PhD
Organizational Affiliation
Ataturk University
Official's Role
Study Director
Facility Information:
Facility Name
Artvin State Hospital Physical Therapy and Rehabilitation outpatient clinic
City
Artvin
ZIP/Postal Code
08000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emre Erkal, PhD Student
Phone
543.375.07.09
Email
emreerkal@hotmail.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Massage of the Trapezius Muscle and Foot in Fibromyalgia Patients

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