Fibromyalgia
Conditions
Keywords
micronutrients, nutrition, therapy, chronic disease
Brief summary
The study had two objectives. The first main aim was to analyze the effects of tryptophan and magnesium-enriched Mediterranean diet on psychological variables (trait anxiety, self-image, mood state, eating disorders) and sleep effects in women with fibromyalgia. Our hypothesis, based on previous positive effects of tryptophan and magnesium supplementation by separate in this population, may improve psychological health and regulate sleep disruptions. The second aim was to assess the effectiveness of a manual therapy technique performed with moderate digital pressure in fibromyalgia patients on the variables of fatigue, pain, sleep, anxiety and mood. It was done to provide an alternative treatment to pharmacological therapies for fibromyalgia patients and to provide new evidence on the effects of manual therapy in fibromyalgia patients.
Interventions
OTHERMediterranean-diet enriched with a higher dose of tryptophan and magnesium
That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium
OTHERIsocaloric diet
That group eaten isocaloric diet plan based on Mediterranean diet.
OTHERManual therapy
That group received moderate pressure digital manual therapy.
OTHERPlacebo therapy
That group was treated with a US (in off mode) without conductive gel.
Sponsors
University of Alicante
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
\- Women aged 40-60 with fibromialgia (officially diagnosed).
Exclusion criteria
* Women used analgesics, vitamins containing supplements, and or other drugs for the treatment of fibromyalgia symptoms, or participation in other clinical trials. * Women that be performing simultaneously to this study some other physical therapy or physical exercise treatment. Not having sufficient cognitive level to collaborate in the study or not having the possibility of attending the established sessions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mood state | 4 - 16 weeks | Mood state assessment: Profile of Mood State inventory. |
| Sleep Quality | 4 - 16 weeks | Sleep Quality assessment: Athenas Insomnia Scale. |
| Anxiety trait | 4 - 16 weeks | Anxiety trait assessment: Stay Trait Anxiety Inventory. |
| Sleep quality | 4 - 16 weeks | Sleep quality assessment: Pittsburgh Sleep Quality Index |
| Fatigue severity | 4 - 16 weeks | Fatigue severity assessment: Fatigue Severity Scale |
| Pain perception | 4 - 16 weeks | Pain perception assessment: Visual Analogical Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 4 - 16 weeks | Body composition assessment trough bioimpedance. |
Countries
Spain
Outcome results
None listed