Clinical trial NCT05512650: Virtual Reality and Meditation for Fibromyalgia
Official title: Use of Virtual Reality for Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Virtual Reality
Meditation
Pain
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Rheumatology Research Foundation
First posted: 2022-08-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Fibromyalgia (FM) is a particularly debilitating rheumatological syndrome which affects millions of adults in the United States. The condition presents with widespread chronic muscular pain and reduced pain thresholds, fatigue, insomnia, and negative affect. Chronic pain that is caused by FM can have significant effects on physical function, psychological parameters, and overall quality of life. Currently, there is a need for safe and effective non-pharmacologic pain-management strategies for FM, and research has shown that virtual reality (VR) may be a useful tool for some of these clients. The literature has suggested improvements in pain scores on a visual analog scale (VAS) for adults with a variety of rheumatological issues, including FM. Additional research has demonstrated that affect was improved for clients with FM who participated in a 10-minute VR mindfulness session. Such findings highlight the potential benefits of VR and mindfulness meditation for clients with FM. However, there is a great deal that remains unknown about the effectiveness of these pain management techniques. Therefore, this pilot study will examine and compare the effectiveness of combining VR and meditation for improving symptoms of FM in adults. We hypothesize that a VR meditation session will facilitate greater improvements in pain, affect, and physiological vital stats as compared to a non-immersive meditation intervention.

Detailed description: Current treatments for fibromyalgia (FM) include pharmaceutical pain medications (ranging from over the counter to prescription opioids) as well as psychological programs with components of relaxation, cognitive therapy, and activity management. However, pain medications are not fully effective, can be addictive, and can cause hyperalgesia, and there is little research on psychological interventions for FM.

One treatment that has demonstrated some efficacy for reducing chronic pain is meditation. Various studies have demonstrated that there are generally reductions in affective pain for those who practice meditation. Another promising treatment option for FM is virtual reality (VR). VR is an immersive 3D experience during which the participant wears a headset or helmet which simulates the sensation of being elsewhere. There is evidence which shows that VR can be an effective treatment for pain reduction. However, most studies which utilize VR as a method of pain reduction focus on acute pain and studies looking at VR for chronic pain are scarce.

One preliminary study examined the utility of VR in treating FM. Results from this study showed that positive affect increased after participants engaged in a 10-minute meditation and mindfulness VR session. Further, they found a slight reduction in the negative impact of FM on overall life and wellbeing, as measured by the FM Impact Questionnaire (FIQ). However, small sample sizes and the addition of other adjunctive therapies limit the significance of these study results. Additional research on VR and meditation for the treatment of FM and other rheumatological conditions also demonstrated reductions in pain scores, offering promising data on meditation and VR being used in combination.

Given the promising literature on VR and meditation, this study will aim to further the field of knowledge surrounding use of VR meditation for reducing pain and increasing affect for adults with FM. Despite the encouraging data on using these interventions for FM, it is unknown whether the immersive aspect of the VR is helping to improve results. This pilot study will aim to address this question by comparing an immersive VR meditation session with a non-immersive, typical meditation for FM patients.

Eligibility criteria: Inclusion Criteria:

1. Adults ages 18 and older (no upper limit)
2. Diagnosis of fibromyalgia with a minimum average pain level of 3 over the last week
3. English-speaking
4. Willing and able to visit the Brigham and Women's Pain Management Center site on two separate occasions to participate in the study

Exclusion Criteria:

1. Unwilling to put on VR headset
2. Experience a seizure in the last 5 years
3. Cognitive impairment
4. Hearing/visual deficit
5. Active, contagious skin infection
6. Eye infections
7. Has a pacemaker or defibrillator
8. Has a hearing aid
9. History of myocardial infarction or other serious cardiovascular condition
10. Current peripheral neuropathy

Primary outcomes:
measure: Pain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention)
timeFrame: 20 minutes after the 10 minute intervention
Secondary outcomes:
measure: Positive and Negative Affect Scale [PANAS]
timeFrame: 20 minutes post the 10 minute meditation intervention
measure: Quantitative Sensory Testing (QST) - Pain Threshold
timeFrame: 20 minutes post the 10 minute meditation intervention
measure: Blood Pressure
timeFrame: Immediately after a 10 minute meditation intervention
measure: Heart Rate
timeFrame: Immediately after a 10 minute meditation intervention
measure: Quantitative Sensory Testing (QST) - Temporal Summation
timeFrame: 20 minutes post the 10 minute meditation intervention
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Pain Management Center
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Nancy A Baker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Venuturupalli RS, Chu T, Vicari M, Kumar A, Fortune N, Spielberg B. Virtual Reality-Based Biofeedback and Guided Meditation in Rheumatology: A Pilot Study. ACR Open Rheumatol. 2019 Nov 11;1(10):667-675. doi: 10.1002/acr2.11092. eCollection 2019 Dec.
citation: Botella C, Garcia-Palacios A, Vizcaino Y, Herrero R, Banos RM, Belmonte MA. Virtual reality in the treatment of fibromyalgia: a pilot study. Cyberpsychol Behav Soc Netw. 2013 Mar;16(3):215-23. doi: 10.1089/cyber.2012.1572.
citation: Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12.
citation: Herrero R, Garcia-Palacios A, Castilla D, Molinari G, Botella C. Virtual reality for the induction of positive emotions in the treatment of fibromyalgia: a pilot study over acceptability, satisfaction, and the effect of virtual reality on mood. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):379-84. doi: 10.1089/cyber.2014.0052.
citation: Hennard J. A protocol and pilot study for managing fibromyalgia with yoga and meditation. Int J Yoga Therap. 2011;(21):109-21.
citation: Ngian GS, Guymer EK, Littlejohn GO. The use of opioids in fibromyalgia. Int J Rheum Dis. 2011 Feb;14(1):6-11. doi: 10.1111/j.1756-185X.2010.01567.x. Epub 2010 Aug 23.