Physiotherapy Methods for Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAnkara Yildirim Beyazıt University
About this trial
The aim of our study was to examine and compare the effects of different physiotherapy methods, namely connective tissue massage, transcutaneous auricular vagus nerve stimulation and both, on pain, health status, sleep quality, fatigue, psychosocial status, autonomic symptoms and quality of life in women with fibromyalgia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having been diagnosed with fibromyalgia
Being female between the ages of 18-65
Volunteering to participate in the study
Disqualifiers
Diagnosed neurological and infectious diseases
Uncontrolled endocrine and/or autoimmune diseases
Serious psychiatric disorders (bipolar disorder, schizophrenia, psychosis, etc.)
Pregnancy or breastfeeding
Trial design
Design model
Factorial
Treatments tested in this trial
Connective tissue massage
Other interventionConnective tissue massage (CTM) is a manual technique that involves applying specific dragging or pulling movements to the superficial and subcutaneous connective tissue layers
Transcutaneous auricular vagus nerve stimulation
Other interventionTranscutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique. It targets vagus nerve stimulation through the transcutaneous application of electrical impulses to the auricle
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: CTM GroupExperimental treatment 1 intervention
Group B: taVNS GroupExperimental treatment 1 intervention
Group C: CTM+taVNS GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Pain intensity as measured by the Visual Analog Scale (VAS)
In the VAS scale, which is a 10 cm scale, '0' represents no pain and '10' represents the worst imaginable pain. The distance from the marked point to the 0 point is measured using a ruler, and the pain intensity is recorded in centimeters.
Time frame
Baseline, 6th week (after treatment)2
Health status and disease severity as measured by the Fibromyalgia Impact Questionnaire (FIQ).
This questionnaire assesses the severity of symptoms, overall impact, and physical function. The total score for the questionnaire ranges from 0 to 100, with higher scores indicating a greater impact of the illness on patients.
Time frame
Baseline, 6th week (after treatment)Secondary outcomes
1
Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. Each question is scored on a scale of 0-3, with a total score ranging from 0 to 21.
Time frame
Baseline, 6th week (after treatment)2
Fatigue as measured by the Visual Analog Scale (VAS).
'0' means no fatigue and '10' means unbearable fatigue. Fatigue level is recorded by measuring the distance from the marked point on the VAS (a 10 cm scale) to the 0 point using a ruler.
Time frame
Baseline, 6th week (after treatment)3
Depression as measured by the Beck Depression Inventory (BDI)
The BDI measures individuals' levels of depression. The scale consists of 21 items in total. Scores range from 0 to 63, with higher scores indicating higher levels of depression.
Time frame
Baseline, 6th week (after treatment)4
Anxiety as measured by the Beck Anxiety Inventory (BAI)
The BAI measures individuals' anxiety levels. The scale consists of 21 items in total. Scores range from 0 to 63, with higher scores indicating higher anxiety levels.
Time frame
Baseline, 6th week (after treatment)Sponsors and contacts
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Source ClinicalTrials.gov