Massage TherapyNCT05865522
Massage of the Trapezius Muscle and Foot in Fibromyalgia Patients
A study testing Trapezius Massage and Foot Massage in people with Massage Therapy, run by Emre Erkal at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Massage Therapy
- What is being tested?
- Trapezius Massage and Foot Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2023to 7 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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,
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- Not receiving physiotherapy in the last 6 months,
- Patients without communication problems were included. Exclusion Criteria
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Artvin State Hospital Physical Therapy and Rehabilitation outpatient clinic
Artvin, Artvin, 08000
About this study
Official title: Evaluation of the Effects of Classical Massage to Trapezius Muscle and Foot in Fibromyalgia Patients
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.
Read the 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.
The aim of this study is to evaluate the effect of classical massage on pain, fibromyalgia severity and quality of life in fibromyalgia patients.
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. Fibromyalgia patients coming to the Physical Therapy and Rehabilitation Unit will be met and informed about the research. Written informed consent will be obtained from patients who agree to participate in the study. VAS will be applied to each patient coming to the outpatient clinic and their fulfilment of the inclusion criteria will be determined. Patient information form, FIQR and SF-36 quality of life scale will be applied.
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.
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 control group will not receive massage. Patients in all three groups will be questioned about their pain with VAS once a week throughout the study.
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 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.
- Conditions
- Massage Therapy
- Being tested
- Trapezius Massage, Foot Massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trapezius MassageOther
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.
Foot MassageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: six week
Secondary outcomes (1)
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.
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start18 May 2023
- Primary completion24 Oct 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massage TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emre Erkal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Erkal, Ataturk University
- Investigators
- Emine Kiyak, PhD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865522
- Sponsor's protocol ID
- EmreTez
- Status last verified
- Dec 2024
- First submitted
- 25 Apr 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Classical Massage to Trapezius Muscle and Foot in Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT05865522
- Acronym / sponsor ID
- EmreTez
- Conditions
- Massage Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Emre ErkalUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
The aim of this study is to evaluate the effect of classical massage on pain, fibromyalgia severity and quality of life in fibromyalgia patients.
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. Fibromyalgia patients coming to the Physical Therapy and Rehabilitation Unit will be met and informed about the research. Written informed consent will be obtained from patients who agree to participate in the study. VAS will be applied to each patient coming to the outpatient clinic and their fulfilment of the inclusion criteria will be determined. Patient information form, FIQR and SF-36 quality of life scale will be applied.
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.
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 control group will not receive massage. Patients in all three groups will be questioned about their pain with VAS once a week throughout the study.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trapezius Massage Group | Experimental | Other: Trapezius MassageThe 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. |
| Foot Massage Group | Experimental | Other: Foot MassageThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 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),
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trapezius MassageThe 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. | Other | Trapezius Massage Group |
| Foot MassageThe 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. | Other | Foot Massage Group |
Primary outcome
Revised Fibromyalgia Impact Questionnaire
Time frame: 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
Visual Analog Scale (VAS)-Pain
Time frame: 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.
1 secondary outcome
SF-36 Quality of Life Scale
Time frame: six week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine Kiyak, PhD study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trapezius Massage and Foot Massage in people with Massage Therapy, run by Emre Erkal at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Fibromyalgia Impact Questionnaire (time frame: six week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.