Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Isocaloric diet; Other: Mediterranean-diet enriched with a higher dose of tryptophan and magnesium; Other: Placebo therapy; Other: Manual therapy

• Registration Number: NCT04158388
• Lead Sponsor: University of Alicante

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-10
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL GROUP	Isocaloric diet	-
EXPERIMENTAL DIET GROUP	Mediterranean-diet enriched with a higher dose of tryptophan and magnesium	-
EXPERIMENTAL PLACEBO GROUP	Placebo therapy	That group was treated with a US (in off mode) without conductive gel. Placebo group.
EXPERIMENTAL MASSAGE GROUP	Manual therapy	That group received moderate pressure digital manual therapy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Body composition	4 - 16 weeks	Body composition assessment trough bioimpedance.

Trial Locations

Locations (1)

University of Alicante; 🇪🇸 Alicante, San Vicente Del Raspeig, Spain