NCT05017220

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

July 5, 2021

Last Update Submit

September 30, 2021

Conditions

Fibromyalgia

Keywords

FibromyalgiaNature-based activitiesPain dimensionsMultisensory stimulationQuantitative sensory testing

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Nature-based stimulation program

EXPERIMENTAL

Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation

Other: Nature-based sensory stimuli

Control intervention

OTHER

Participants will be involved in a placebo task for 30 minutes

Other: Control group intervention

Interventions

Nature-based sensory stimuliOTHER

A program based on stimulation using nature-based sensory stimuli will be implemented

Also known as: Biogenic sensory stimuli
Nature-based stimulation program
Control group interventionOTHER

An activity based on a placebo intervention will be implemented

Control intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Health Sciences

Granada, 18008, Spain

Location

Universidad de Granada

Granada, 18008, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator / Associate professor

Study Record Dates

First Submitted

July 5, 2021

First Posted

August 23, 2021

Study Start

July 15, 2021

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)