Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

NCT ID: NCT04158388

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-10-10

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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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EXPERIMENTAL DIET GROUP

Group Type EXPERIMENTAL

Mediterranean-diet enriched with a higher dose of tryptophan and magnesium

Intervention Type OTHER

That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium

CONTROL GROUP

Group Type OTHER

Isocaloric diet

Intervention Type OTHER

That group eaten isocaloric diet plan based on Mediterranean diet.

EXPERIMENTAL MASSAGE GROUP

That group received moderate pressure digital manual therapy.

Group Type EXPERIMENTAL

Manual therapy

Intervention Type OTHER

That group received moderate pressure digital manual therapy.

EXPERIMENTAL PLACEBO GROUP

That group was treated with a US (in off mode) without conductive gel. Placebo group.

Group Type EXPERIMENTAL

Placebo therapy

Intervention Type OTHER

That group was treated with a US (in off mode) without conductive gel.

Interventions

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Mediterranean-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

Intervention Type OTHER

Isocaloric diet

That group eaten isocaloric diet plan based on Mediterranean diet.

Intervention Type OTHER

Manual therapy

That group received moderate pressure digital manual therapy.

Intervention Type OTHER

Placebo therapy

That group was treated with a US (in off mode) without conductive gel.

Intervention Type OTHER

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alicante

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Alejandro Martínez-Rodríguez

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alicante

Alicante, San Vicente Del Raspeig, Spain

Site Status

Countries

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Spain

Other Identifiers

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UA-2019-04-10

Identifier Type: -

Identifier Source: org_study_id

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