FibromyalgiaNCT05017220
Nature-based Sensory Stimulation on Pain Levels
A study testing Nature-based sensory stimuli in people with Fibromyalgia, run by Universidad de Granada at 2 sites in Spain.
Trial summary
This randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Nature-based sensory stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Jul 2021to 31 Aug 2021
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fibromyalgia syndrome (ACR criteria 2016).
- Chronic widespread musculoskeletal pain symptoms (>1 location using the Widespread Pain Index).
- High-intensity pain (VAS ≥ 4), at least 3 days a week for the previous 3 months.
- If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment
- Over 18 and less than 65 years old (labour active).
- Ability to speak and understand English or Spanish.
Who cannot join
- Acute or temporal pain
- Severe cognitive impairment, detected by the Mini-Mental State Examination (score <24 out of 30 points)
- Severe mental disorders in acute phase or symptomatic phase
- Behavioural alterations as this may interfere in their participation
- Severe intellectual disability
- Other severe or medically unstable diseases interfering with the project participation
Show all 10Show fewer
- Co-occurrence of neuropathic pain
- Other disorders that may cause pain
- Pregnant or breast-feeding
- Drug abuse within the past year.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Faculty of Health Sciences
Granada, 18008
Universidad de Granada
Granada, 18008
About this study
Official title: The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial
This randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia
Read the detailed description
All participants will continue to receive their usual pharmacological treatment as previously established by the Andalusian Public Health System. The intervention will comprise interaction tasks with biotic and abiotic agents for 30 minutes.
- Conditions
- Fibromyalgia
- Being tested
- Nature-based sensory stimuli, Control group intervention
- Keywords
- Fibromyalgia, Nature-based activities, Pain dimensions, Multisensory stimulation, Quantitative sensory testing
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based sensory stimuliOther
Also called Biogenic sensory stimuli
A program based on stimulation using nature-based sensory stimuli will be implemented
Control group interventionOther
An activity based on a placebo intervention will be implemented
| Study group | Role | What they receive |
|---|---|---|
| Nature-based stimulation program | Experimental | Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation Receives: Other: Nature-based sensory stimuli |
| Control intervention | Other | Participants will be involved in a placebo task for 30 minutes Receives: Other: Control group intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Clinical pain intensity assessed by an 11-points Numeric Rating Scale (NRS-11) ranging from 0 to 10
Measured: Change from baseline pain intensity after 30 minutes
Cold pain thresholds
Cold pressor test will be used
Measured: Change from baseline cold pain thresholds after 30 minutes
Punctate mechanical hyperalgesia
Semmes-Weinstein monofilament (Aesthesio® Precise Tactile Sensory Evaluator, DanMic Global, LLC, San Jose, CA, USA) calibrated to bend at 300 gm (2940 mN; size 6.65; 0.1143 cm in diameter) of pressure with a response-dependent method will be used
Measured: Change from baseline mechanical hyperalgesia after 30 minutes
Wind-up phenomenon
Wind-up is a frequency- and intensity-dependent increase in the excitability of dorsal horn neuron that results in a temporal summation of pain perception.
Measured: Change from baseline temporal summation of pain perception after 30 minutes
Pressure pain thresholds
The minimum pressure force which induces pain when pressure is applied on tissues is regarded as the pressure pain threshold
Measured: Change from baseline pressure pain thresholds after 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start15 Jul 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Manuel Pérez Mármol, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017220
- Sponsor's protocol ID
- NBS in chronic pain patients
- Status last verified
- Sep 2021
- First submitted
- 5 Jul 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05017220
- Acronym / sponsor ID
- NBS in chronic pain patients
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Nature-based activities, Pain dimensions, Multisensory stimulation, Quantitative sensory testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 23 Aug 2021 (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.
This randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia
Detailed description
All participants will continue to receive their usual pharmacological treatment as previously established by the Andalusian Public Health System. The intervention will comprise interaction tasks with biotic and abiotic agents for 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature-based stimulation program | Experimental | Other: Nature-based sensory stimuliParticipants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation |
| Control intervention | Other | Other: Control group interventionParticipants will be involved in a placebo task for 30 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of fibromyalgia syndrome (ACR criteria 2016).
- Chronic widespread musculoskeletal pain symptoms (>1 location using the Widespread Pain Index).
- High-intensity pain (VAS ≥ 4), at least 3 days a week for the previous 3 months.
- If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment
- Over 18 and less than 65 years old (labour active).
Key exclusion criteria (10 listed)
- Acute or temporal pain
- Severe cognitive impairment, detected by the Mini-Mental State Examination (score <24 out of 30 points)
- Severe mental disorders in acute phase or symptomatic phase
- Behavioural alterations as this may interfere in their participation
- Severe intellectual disability
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 |
|---|---|---|
| Nature-based sensory stimuliAlso: Biogenic sensory stimuliA program based on stimulation using nature-based sensory stimuli will be implemented | Other | Nature-based stimulation program |
| Control group interventionAn activity based on a placebo intervention will be implemented | Other | Control intervention |
Primary outcome
Pain intensity
Time frame: Change from baseline pain intensity after 30 minutes
Clinical pain intensity assessed by an 11-points Numeric Rating Scale (NRS-11) ranging from 0 to 10
Cold pain thresholds
Time frame: Change from baseline cold pain thresholds after 30 minutes
Cold pressor test will be used
Punctate mechanical hyperalgesia
Time frame: Change from baseline mechanical hyperalgesia after 30 minutes
Semmes-Weinstein monofilament (Aesthesio® Precise Tactile Sensory Evaluator, DanMic Global, LLC, San Jose, CA, USA) calibrated to bend at 300 gm (2940 mN; size 6.65; 0.1143 cm in diameter) of pressure with a response-dependent method will be used
Wind-up phenomenon
Time frame: Change from baseline temporal summation of pain perception after 30 minutes
Wind-up is a frequency- and intensity-dependent increase in the excitability of dorsal horn neuron that results in a temporal summation of pain perception.
Pressure pain thresholds
Time frame: Change from baseline pressure pain thresholds after 30 minutes
The minimum pressure force which induces pain when pressure is applied on tissues is regarded as the pressure pain threshold
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 8 Oct 2021.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-based sensory stimuli in people with Fibromyalgia, run by Universidad de Granada at 2 sites 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 6 inclusion and 10 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 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pain intensity (time frame: Change from baseline pain intensity after 30 minutes). The study lists 5 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 8 Oct 2021.