Massage of the Trapezius Muscle and Foot in Fibromyalgia Patients

NCT05865522 | Completed

• 1 other identifier: EmreTez
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The aim of this study is to evaluate the effect of classical massage on pain, fibromyalgia severity and quality of life in fibromyalgia patients. 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 group , foot group and control group. In the physical therapy unit, the patients in trapezius group will receive a total of 12 sessions of trapezius massage, 2 sessions per week for 6 weeks; the patients in foot group will receive a total of 12 sessions of foot massage, 2 sessions per week for 6 weeks and control group 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.

Conditions

Massage Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• SF-36 Quality of Life Scale

  six week

Study Arms (3)

Trapezius Massage Group

EXPERIMENTAL

The patients inTrapezius 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 groups will be questioned about their pain with VAS once a week throughout the study. Pain follow-up of the patients in trapezius massage will be performed 48 hours after the massage.

Other: Trapezius Massage

Foot Massage Group

EXPERIMENTAL

The patients in Foot 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 groups will be questioned about their pain with VAS once a week throughout the study. Pain follow-up of the patients in Foot Massage Group will be performed 48 hours after the massage.

Other: Foot Massage

Control Group

NO INTERVENTION

Patients in Control Group will not receive massage. Patients in control groups will be questioned about their pain with VAS once a week throughout the study.

Interventions

Trapezius Massage OTHER

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.

Trapezius Massage Group

Foot Massage OTHER

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.

Foot Massage Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over,
• Diagnosed with fibromyalgia according to ACR 2010 diagnostic criteria
• VAS Pain score of 5 and above,
• No impediment to massage (advanced COPD, asthma, heart or kidney failure, malignant conditions, febrile diseases and pregnancy),
• The areas to be massaged are free of any problems (rash, redness, lesions, temperature increase, swelling, oedema, bone anomalies and localised infections),
• Not using any analgesic medication in the last 24 hours,
• Not receiving physiotherapy in the last 6 months,

You may not qualify if:

• Receiving physiotherapy,
• Changing pharmacological treatment regimen,
• The one who doesn't come to massage sessions,
• Patients with undesirable effects (bruising and bruising of the skin, etc.) in the massage area were excluded from the study.

Sponsors & Collaborators

• Emre Erkal: lead

Study Sites (1)

Artvin State Hospital Physical Therapy and Rehabilitation outpatient clinic

Artvin, Artvin, 08000, Turkey (Türkiye)

Location

Study Officials

• Emine Kiyak, PhD

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 19, 2023
• Study Start: May 18, 2023
• Primary Completion: October 24, 2023
• Study Completion: December 7, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)