Back to resultsEffects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mediterranean-diet enriched with a higher dose of tryptophan and magnesium
Isocaloric diet
Manual therapy
Placebo therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring micronutrients, nutrition, therapy, chronic disease
Eligibility Criteria
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.
Sites / Locations
- University of Alicante
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Experimental
Arm Label
EXPERIMENTAL DIET GROUP
CONTROL GROUP
EXPERIMENTAL MASSAGE GROUP
EXPERIMENTAL PLACEBO GROUP
Arm Description
That group received moderate pressure digital manual therapy.
That group was treated with a US (in off mode) without conductive gel. Placebo group.
Outcomes
Primary Outcome Measures
Sleep Quality
Sleep Quality assessment: Athenas Insomnia Scale.
Anxiety trait
Anxiety trait assessment: Stay Trait Anxiety Inventory.
Mood state
Mood state assessment: Profile of Mood State inventory.
Fatigue severity
Fatigue severity assessment: Fatigue Severity Scale
Pain perception
Pain perception assessment: Visual Analogical Scale
Sleep quality
Sleep quality assessment: Pittsburgh Sleep Quality Index
Secondary Outcome Measures
Body composition
Body composition assessment trough bioimpedance.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04158388
Brief Title
Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia
Official Title
Effects of Nutritional Strategies or Manual Therapies on Physical and Psychological Parameters in Women With Fybromyalgia.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 9, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alicante
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
micronutrients, nutrition, therapy, chronic disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPERIMENTAL DIET GROUP
Arm Type
Experimental
Arm Title
CONTROL GROUP
Arm Type
Other
Arm Title
EXPERIMENTAL MASSAGE GROUP
Arm Type
Experimental
Arm Description
That group received moderate pressure digital manual therapy.
Arm Title
EXPERIMENTAL PLACEBO GROUP
Arm Type
Experimental
Arm Description
That group was treated with a US (in off mode) without conductive gel. Placebo group.
Intervention Type
Other
Intervention Name(s)
Mediterranean-diet enriched with a higher dose of tryptophan and magnesium
Intervention Description
That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium
Intervention Type
Other
Intervention Name(s)
Isocaloric diet
Intervention Description
That group eaten isocaloric diet plan based on Mediterranean diet.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
That group received moderate pressure digital manual therapy.
Intervention Type
Other
Intervention Name(s)
Placebo therapy
Intervention Description
That group was treated with a US (in off mode) without conductive gel.
Primary Outcome Measure Information:
Title
Sleep Quality
Description
Sleep Quality assessment: Athenas Insomnia Scale.
Time Frame
4 - 16 weeks
Title
Anxiety trait
Description
Anxiety trait assessment: Stay Trait Anxiety Inventory.
Time Frame
4 - 16 weeks
Title
Mood state
Description
Mood state assessment: Profile of Mood State inventory.
Time Frame
4 - 16 weeks
Title
Fatigue severity
Description
Fatigue severity assessment: Fatigue Severity Scale
Time Frame
4 - 16 weeks
Title
Pain perception
Description
Pain perception assessment: Visual Analogical Scale
Time Frame
4 - 16 weeks
Title
Sleep quality
Description
Sleep quality assessment: Pittsburgh Sleep Quality Index
Time Frame
4 - 16 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
Body composition assessment trough bioimpedance.
Time Frame
4 - 16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Alicante
City
Alicante
State/Province
San Vicente Del Raspeig
ZIP/Postal Code
03690
Country
Spain
12. IPD Sharing Statement
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Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia
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