The Use of Virtual Reality for Lumbar Pain Management in an Outpatient Spine Clinic

NCT03819907 | Completed

• 1 other identifier: 2018P003042Final
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The management of chronic pain is a significant public health issue related to escalating treatment costs, lost productivity, disability and medication use. The prevalence of chronic pain is rising alarmingly across all subpopulations with chronic low back pain (LBP) being labeled as one of the 15 most expensive medical conditions. Both study investigators are involved in the medical treatment of these patients. The investigators are interested in testing the effectiveness of alternative treatment strategies that address the complexity of chronic pain that is often mediated not only by physiologic variables, but also psychosocial issues. There is emerging evidence that Virtual Reality (VR) may be an effective pain management tool to augment care in this population, reducing medical costs, decreasing medication use, improving outcomes and empowering patients to take more control over their own health and management of chronic pain. Less is known about the use of this technology delivered in the context of care delivered in an outpatient clinical setting.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change is being assessed between two time points by The Numeric Pain Rating Scale

  Self-report current pain rating on a 0-10 scale with 0 being no pain and 10 being the worst pain imaginable

  First time point: At the beginning of the injection clinic visit, prior to receiving the injection. Second time point: approximately 1 hour later, at the conclusion of the injection clinic visit, after receiving the injection

Secondary Outcomes (2)

• Change is being assessed between two time points by The Anxiety Thermometer

  First time point: At the beginning of the injection clinic visit, prior to receiving the injection. Second time point: approximately 1 hour later, at the conclusion of the injection clinic visit, after receiving the injection

• Virtual Reality Symptom Questionnaire

  Measured at one time point approximately 1 hour from the time of randomization

Other Outcomes (1)

• Interest questions about the guided relaxation content

  Measured at one time point approximately 1 hour from the time of randomization

Study Arms (3)

Control

NO INTERVENTION

15 participants will be randomly assigned to the control group. They will receive no intervention other than the injection (which is not a part of the trial). Pre-injection they will receive all baseline measures and questionnaires. Post injection they will receive the primary outcome measures: 1) Numeric Pain Rating Scale and 2) Anxiety thermometer

Audiovisual (AV) Guided Relaxation

ACTIVE COMPARATOR

Combination Product: Audiovisual Guided Relaxation Five-minute guided relaxation delivered via a computer screen and speakers

Combination Product: Audiovisual Guided Relaxation

Virtual Reality (VR) Guided Relaxation

EXPERIMENTAL

Combination Product: Virtual Reality Guided Relaxation Five-minute guided relaxation delivered via a Samsung Galaxy 7s and the Samsung adaptable VR headset. Other Names: • Samsung Galaxy 7s/Samsung adaptable VR headset

Combination Product: Virtual Reality Guided Relaxation

Interventions

Audiovisual Guided Relaxation COMBINATION_PRODUCT

Five-minute guided relaxation delivered via a computer screen and speakers

Audiovisual (AV) Guided Relaxation

Virtual Reality Guided Relaxation COMBINATION_PRODUCT

Five-minute guided relaxation delivered via a Samsung Galaxy 7s and the Samsung adaptable VR headset.

Virtual Reality (VR) Guided Relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients attending an appointment to receive a lumbar spinal injection.
• Patients meeting the definition of chronic LBP as established by the NIH task force: Back pain problem that has persisted at least 3 months, and has resulted in pain on at least half the days in the past 6 months

You may not qualify if:

• Age younger than 18 years
• Not being fluent and literate in English
• Patients receiving injections in areas other than the lumbar or pelvic region

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

• Ames SL, Wolffsohn JS, McBrien NA. The development of a symptom questionnaire for assessing virtual reality viewing using a head-mounted display. Optom Vis Sci. 2005 Mar;82(3):168-76. doi: 10.1097/01.opx.0000156307.95086.6.

  PMID: 15767873 BACKGROUND

• Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.

  PMID: 24787228 BACKGROUND

• Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.

  PMID: 30052655 BACKGROUND

• Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

  PMID: 15928561 BACKGROUND

• Dascal J, Reid M, IsHak WW, Spiegel B, Recacho J, Rosen B, Danovitch I. Virtual Reality and Medical Inpatients: A Systematic Review of Randomized, Controlled Trials. Innov Clin Neurosci. 2017 Feb 1;14(1-2):14-21. eCollection 2017 Jan-Feb.

  PMID: 28386517 BACKGROUND

• Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

  PMID: 11690728 BACKGROUND

• Houtman IL, Bakker FC. The anxiety thermometer: a validation study. J Pers Assess. 1989 Fall;53(3):575-82. doi: 10.1207/s15327752jpa5303_14.

  PMID: 2778618 BACKGROUND

• Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.

  PMID: 29485536 BACKGROUND

• Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. 2015 Feb 18;350:h444. doi: 10.1136/bmj.h444.

  PMID: 25694111 BACKGROUND

• Westenberg RF, Zale EL, Heinhuis TJ, Ozkan S, Nazzal A, Lee SG, Chen NC, Vranceanu AM. Does a Brief Mindfulness Exercise Improve Outcomes in Upper Extremity Patients? A Randomized Controlled Trial. Clin Orthop Relat Res. 2018 Apr;476(4):790-798. doi: 10.1007/s11999.0000000000000086.

  PMID: 29480886 BACKGROUND

Related Links

• Institute of Medicine (US) Committee on Advancing Pain Research,Care, and Education. (2011). Relieving {Pain} in {America}: {A} {Blueprint} for{Transforming} {Prevention}, {Care}, {Education}, and {Research}.
• Kamper, S. J., Apeldoorn, A. T., Chiarotto, A., Smeets, R. J. E. M.,Ostelo, R. W. J. G., Guzman, J., \& Tulder, M. W. V. (2015). Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ

Study Officials

• David S Binder, MD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Innovation

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 29, 2019
• Study Start: April 8, 2019
• Primary Completion: July 9, 2019
• Study Completion: September 1, 2019
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)