Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome

Completed · Not applicable

Conditions studied: Amplified Musculoskeletal Pain Syndrome, Reflex Sympathetic Dystrophy, Complex Regional Pain Syndromes

In brief

A pilot randomized controlled trial to assess feasibility, acceptability and generate outcome domains for a future RCT testing the efficacy of immersive virtual reality on pain intensity in pediatric amplified musculoskeletal pain syndrome.

Key facts

Study ID

NCT03762213

Run by

Tufts Medical Center

People needed

30

Starts

2018-12-20

Expected to finish

2019-08-29

Last updated by the study team

2021-01-26

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of AMPS, including CRPS, or localized or diffuse amplified pain syndrome as determined by the primary pediatric rheumatologist and coded in EMR.
• Informed consent for caregivers and child assent for participants.

You may not qualify if…

• An underlying organic cause can explain the pain including inflammatory, infectious, traumatic or malignant etiologies as determined by the primary pediatric rheumatologist.
• Participant or caregiver report of any history of motion sickness, underlying epilepsy, severe headaches in the participant or other conditions where the use of visual exposures to stimuli is contraindicated.
• Inability to report a pain score and/or incapacity to give assent due to intellectual deficit.
• Blindness.
• Non-English-speaking subjects will be excluded due to the unavailability of the content of the VR application used in this study in languages other than English.
• Any other condition that the investigators think can compromise the integrity of the study or subject safety.

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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