Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05865522 |
| Other study ID # |
EmreTez |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 18, 2023 |
| Est. completion date |
May 18, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Ataturk University |
| Contact |
Emre ERKAL, PhD Student |
| Phone |
543.375.07.09 |
| Email |
emreerkal[@]hotmail.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
