Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

University of Alicante

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Mediterranean-diet enriched with a higher dose of tryptophan and magnesium; Other: Placebo therapy; Other: Isocaloric diet; Other: Manual therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04158388

UA-2019-04-10

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 4 patient groups

EXPERIMENTAL DIET GROUP

Experimental group

Treatment:

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

CONTROL GROUP

Other group

Treatment:

Other: Isocaloric diet

EXPERIMENTAL MASSAGE GROUP

Experimental group

Description:

That group received moderate pressure digital manual therapy.

Treatment:

Other: Manual therapy

EXPERIMENTAL PLACEBO GROUP

Experimental group

Description:

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

Treatment:

Other: Placebo therapy