Trial · NCT04316702
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fibromyalgia Impact Questionnaire (FIQ) questionnaire | at 3 months | Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of treatment period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome |
| Primary | Fibromyalgia Impact Questionnaire (FIQ) questionnaire | at 6 months | Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of follow up period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome |
| Secondary | Widespread pain index questionnaire | at baseline, 3 months, 6 months | Fibromyalgia syndrome symptoms questionnaire named:Wide Spread Pain Index (scale 0-19, higher score means worse outcome) |
| Secondary | Symptoms severity scale questionnaire | at baseline, 3 months, 6 months | Fibromyalgia syndrome symptoms questionnaire named:Symptom Severity Scale (SSS) (scale 0-12, higher score means worse outcome) |
| Secondary | Post traumatic stress disorder (PTSD) symptoms scale (PSS) questionnaire | at baseline, 3 months, 6 months | a 17-item semi-structured interview that assesses the presence and severity of Diagnostic and Statistical Manual (DSM-IV) PTSD symptoms related to a single identified traumatic event in individuals with a known trauma history. scale 0-51, higher score means worse outcome |
| Secondary | Medical somatic dissociation questionnaire (MSDQ) | at baseline, 3 months, 6 months | assess somatic dissociation in the healthcare system setting, Scale 5-130, higher score means worse outcome |
| Secondary | Recovery promoting relationships scale (RPRS) | at baseline, 3 months, 6 months | assesses patient-therapist relationships from the patient's perspective. |
| Secondary | the brief symptom inventory (BSI-18) | at baseline, 3 months, 6 months | evaluate psychological distress, three sub-scales: depression, anxiety, and somatization. scale of 0-24, higher score means worse outcome. |
| Secondary | Beck depression inventory (BDI) | at baseline, 3 months, 6 months | a 21-question multiple choice self-report inventory, designed to measure severity of depression. scale of 0-63, higher score means worse outcome |
| Secondary | Short form health survey (sf-36) | at baseline, 3 months, 6 months | Quality of life questionnaire, scale of 0-100, higher score means better outcome |
| Secondary | patient's global impression of change PGIC questionnaire | at 3 months, at 6 months | patient's global impression of change questionnaire, scale of 1-7, higher score means better outcome |
| Secondary | draw a person (DAP) assignment | at baseline, 3 months, 6 months | self drawing tool, allows the expression of hidden or repressed thoughts and feelings in a relatively rapid and simple way by passing the censorship defensive mechanism |
| Secondary | Heat pain threshold | at baseline, 3 months | Heat pain threshold is determined as the minimum temperature causing pain. Thermal pain is induced with thermal electrode (thermode). Thermode temperature will initially be set at 32.0°C and gradually increase at a rate of 0.3°C/sec. Participants will be instructed to report when the sensation produced by the thermode changed from heat sensation to pain (heat-pain threshold). This procedure will be conducted three times for every subject and the mean of the trials will be calculated. |
| Secondary | conditioned pain modulation using Heat test-stimulus (HTS) | at baseline, 3 months | Following heat pain thresholds assessments, the thermode will be applied on the forearm for 120 seconds at constant temperature. The temperature will be individually adapted to induce a mean pain intensity of 50/100, Participant's pain intensity will be evaluated by numeric pain rating scale (NPRS) ranging from 0 (no pain) to 100 (most intense pain tolerable). The 120-second HTS will be done before and during cold water immersion of the contralateral hand in 10 Celsius degrees, using the same thermode temperature to measure conditioned pain modulation (CPM). CPM efficiency will be evaluated by computing the difference in mean pain intensity induced by the pressure stimulus and the Heat test-stimulus (HTS) before and during the Cold water immersion of the opposite hand. Thus, effective pain inhibitory mechanisms are represented by higher (positive) values |
| Secondary | Cerebral blood volume | at baseline, 3 months | Cerebral blood volume (in milliliter) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC). |
| Secondary | Cerebral blood Flow | at baseline, 3 months | Cerebral blood volume (in milliliter/min) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC). |
| Secondary | Fractional anisotropy | at baseline, 3 months | Brain microstructure imaging will evaluate fractional anisotropy (FA , scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI) |
| Secondary | Mean diffusivity | at baseline, 3 months | Brain microstructure imaging will evaluate mean diffusivity (MD, scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI). |
| Secondary | Brain function imaging | at baseline, 3 months | Resting state fMRI(rsfMRI or R-fMRI)- a method of functional brain imaging that can be used to evaluate regional interactions that occur when a subject is not performing an explicit task. This resting brain activity is observed through changes in blood flow in the brain which creates what is referred to as a blood-oxygen-level dependent (BOLD) signal that can be measured using functional Magnetic Resonance Imaging (fMRI). |
| Secondary | Metabolic Brain function imaging | at baseline, 3 months | Brain Single photon emission computed tomography (SPECT) will be conducted. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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