FibromyalgiaNCT04158388
Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia
A study testing Mediterranean-diet enriched with a higher dose of tryptophan and magnesium, Isocaloric diet and Manual therapy in people with Fibromyalgia, run by University of Alicante at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Mediterranean-diet enriched with a higher dose of tryptophan and magnesium, Isocaloric diet and Manual therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2019to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 40-60 with fibromialgia (officially diagnosed).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- Mediterranean-diet enriched with a higher dose of tryptophan and magnesium, Isocaloric diet, Manual therapy, Placebo therapy
- Keywords
- micronutrients, nutrition, therapy, chronic disease
- Medical subject headings
- Fibromyalgia, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean-diet enriched with a higher dose of tryptophan and magnesiumOther
That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium
Isocaloric dietOther
That group eaten isocaloric diet plan based on Mediterranean diet.
Manual therapyOther
That group received moderate pressure digital manual therapy.
Placebo therapyOther
That group was treated with a US (in off mode) without conductive gel.
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL DIET GROUP | Experimental | Not described Receives: Other: Mediterranean-diet enriched with a higher dose of tryptophan and magnesium |
| CONTROL GROUP | Other | Not described Receives: Other: Isocaloric diet |
| EXPERIMENTAL MASSAGE GROUP | Experimental | That group received moderate pressure digital manual therapy. Receives: Other: Manual therapy |
| EXPERIMENTAL PLACEBO GROUP | Experimental | That group was treated with a US (in off mode) without conductive gel. Placebo group. Receives: Other: Placebo therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep Quality assessment: Athenas Insomnia Scale.
Measured: 4 - 16 weeks
Anxiety trait
Anxiety trait assessment: Stay Trait Anxiety Inventory.
Measured: 4 - 16 weeks
Mood state
Mood state assessment: Profile of Mood State inventory.
Measured: 4 - 16 weeks
Fatigue severity
Fatigue severity assessment: Fatigue Severity Scale
Measured: 4 - 16 weeks
Pain perception
Pain perception assessment: Visual Analogical Scale
Measured: 4 - 16 weeks
Sleep quality
Sleep quality assessment: Pittsburgh Sleep Quality Index
Measured: 4 - 16 weeks
Secondary outcomes (1)
Body composition
Body composition assessment trough bioimpedance.
Measured: 4 - 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 May 2019
- Primary completion9 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158388
- Sponsor's protocol ID
- UA-2019-04-10
- Status last verified
- May 2020
- First submitted
- 14 Oct 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Strategies or Manual Therapies on Physical and Psychological Parameters in Women With Fybromyalgia.
- ClinicalTrials.gov ID
- NCT04158388
- Acronym / sponsor ID
- UA-2019-04-10
- Conditions
- Fibromyalgia
- Keywords
- micronutrients, nutrition, therapy, chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL DIET GROUP | Experimental | Other: Mediterranean-diet enriched with a higher dose of tryptophan and magnesium |
| CONTROL GROUP | Other | Other: Isocaloric diet |
| EXPERIMENTAL MASSAGE GROUP | Experimental | Other: Manual therapyThat group received moderate pressure digital manual therapy. |
| EXPERIMENTAL PLACEBO GROUP | Experimental | Other: Placebo therapyThat group was treated with a US (in off mode) without conductive gel. Placebo group. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 40-60 with fibromialgia (officially diagnosed).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean-diet enriched with a higher dose of tryptophan and magnesiumThat gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium | Other | EXPERIMENTAL DIET GROUP |
| Isocaloric dietThat group eaten isocaloric diet plan based on Mediterranean diet. | Other | CONTROL GROUP |
| Manual therapyThat group received moderate pressure digital manual therapy. | Other | EXPERIMENTAL MASSAGE GROUP |
| Placebo therapyThat group was treated with a US (in off mode) without conductive gel. | Other | EXPERIMENTAL PLACEBO GROUP |
Primary outcome
Sleep Quality
Time frame: 4 - 16 weeks
Sleep Quality assessment: Athenas Insomnia Scale.
Anxiety trait
Time frame: 4 - 16 weeks
Anxiety trait assessment: Stay Trait Anxiety Inventory.
Mood state
Time frame: 4 - 16 weeks
Mood state assessment: Profile of Mood State inventory.
Fatigue severity
Time frame: 4 - 16 weeks
Fatigue severity assessment: Fatigue Severity Scale
Pain perception
Time frame: 4 - 16 weeks
Pain perception assessment: Visual Analogical Scale
Sleep quality
Time frame: 4 - 16 weeks
Sleep quality assessment: Pittsburgh Sleep Quality Index
1 secondary outcome
Body composition
Time frame: 4 - 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean-diet enriched with a higher dose of tryptophan and magnesium, Isocaloric diet and Manual therapy in people with Fibromyalgia, run by University of Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 4 - 16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.