Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nature-based stimulation program | Experimental | Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation |
|
| Control intervention | Other | Participants will be involved in a placebo task for 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nature-based sensory stimuli | Other | A program based on stimulation using nature-based sensory stimuli will be implemented |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Clinical pain intensity assessed by an 11-points Numeric Rating Scale (NRS-11) ranging from 0 to 10 | Change from baseline pain intensity after 30 minutes |
| Cold pain thresholds | Cold pressor test will be used | 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 | 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. | 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 | Change from baseline pressure pain thresholds after 30 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Sciences | Granada | 18008 | Spain | |||
| Universidad de Granada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control group intervention | Other | An activity based on a placebo intervention will be implemented |
|
| Granada |
| 18008 |
| Spain |
| D009422 |
| Nervous System Diseases |