Fibromyalgia
Conditions
Keywords
Fibromyalgia, Nature-based activities, Pain dimensions, Multisensory stimulation, Quantitative sensory testing
Brief 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
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.
Interventions
OTHERNature-based sensory stimuli
A program based on stimulation using nature-based sensory stimuli will be implemented
An activity based on a placebo intervention will be implemented
Sponsors
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Co-occurrence of neuropathic pain * Other disorders that may cause pain * Pregnant or breast-feeding * Drug abuse within the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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 | Change from baseline cold pain thresholds after 30 minutes | Cold pressor test will be used |
| Punctate mechanical hyperalgesia | 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 | 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 | 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 |
Countries
Spain
Outcome results
None listed