Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

May 8, 2020 updated by: Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • San Vicente Del Raspeig
      • Alicante, San Vicente Del Raspeig, Spain, 03690
        • University of Alicante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERIMENTAL DIET GROUP
Other: 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
Other: CONTROL GROUP
Other: Isocaloric diet
That group eaten isocaloric diet plan based on Mediterranean diet.
Experimental: EXPERIMENTAL MASSAGE GROUP
That group received moderate pressure digital manual therapy.
Other: Manual therapy
That group received moderate pressure digital manual therapy.
Experimental: EXPERIMENTAL PLACEBO GROUP
That group was treated with a US (in off mode) without conductive gel. Placebo group.
Other: Placebo therapy
That group was treated with a US (in off mode) without conductive gel.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alicante

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

October 9, 2019

Study Completion (Actual)

October 10, 2019

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 8, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UA-2019-04-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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