Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Nutritional Strategies or Manual Therapies on Physical and Psychological Parameters in Women With Fybromyalgia.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Mediterranean-diet enriched with a higher dose of tryptophan and magnesium
* Other: Isocaloric diet
* Other: Manual therapy
* Other: Placebo therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPERIMENTAL DIET GROUP<br> | Other: Mediterranean-diet enriched with a higher dose of tryptophan and magnesium<br>* That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium<br>|
| Other: CONTROL GROUP<br> | Other: Isocaloric diet<br>* That group eaten isocaloric diet plan based on Mediterranean diet.<br>|
| Experimental: EXPERIMENTAL MASSAGE GROUP<br>That group received moderate pressure digital manual therapy. | Other: Manual therapy<br>* That group received moderate pressure digital manual therapy.<br>|
| Experimental: EXPERIMENTAL PLACEBO GROUP<br>That group was treated with a US (in off mode) without conductive gel. Placebo group. | Other: Placebo therapy<br>* That group was treated with a US (in off mode) without conductive gel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Sleep Quality assessment: Athenas Insomnia Scale. | 4 - 16 weeks | 
| Anxiety trait | Anxiety trait assessment: Stay Trait Anxiety Inventory. | 4 - 16 weeks | 
| Mood state | Mood state assessment: Profile of Mood State inventory. | 4 - 16 weeks | 
| Fatigue severity | Fatigue severity assessment: Fatigue Severity Scale | 4 - 16 weeks | 
| Pain perception | Pain perception assessment: Visual Analogical Scale | 4 - 16 weeks | 
| Sleep quality | Sleep quality assessment: Pittsburgh Sleep Quality Index | 4 - 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Body composition assessment trough bioimpedance. | 4 - 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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micronutrients, nutrition, therapy, chronic disease