NCT01899508

Brief Summary

This study is looking at whether virtual reality combined with pain coping skills training helps reduce pain in people who suffer from OA of the knee. Eligible participants will be asked to come into the study offices for one visit where they will fill out a couple of questionnaires, do some low impact performance tasks and be taught pain coping skills while looking into a 3D virtual reality viewer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

June 26, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2015

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

June 26, 2013

Last Update Submit

August 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Virtual Reality in Pain Coping

    The primary objective of this study is to examine the feasibility and acceptability of a new virtual reality (VR) protocol that uses an iPod Touch/iPhone (or similar smartphone) to deliver virtual reality (VR). Feasibility will be assessed by examining overall accrual, attrition, and adherence to the study protocol. Ratings on a standardized measure of treatment credibility will be examined as well as a Treatment Attitude Questionnaire to assess acceptability.

    1.5 hours

Secondary Outcomes (1)

  • Change in self reported pain

    1.5 hours

Study Arms (1)

Pain Coping Training with 3D viewer

EXPERIMENTAL

All participants will receive a 1 and a half hour pain coping training while using the virtual reality viewer. We are testing the feasability of using the 3D viewer in collaboration with Pain Coping training to see if people who suffer from Osteoarthritis of the knee experience some pain relief.

Procedure: Virtual Reality Training SessionDevice: 3D viewer with iPod Touch/iPhone (or similar smartphone)

Interventions

The participant will meet with an interventionist for an hour and a half long session. During this session OA knee pain will be assessed (using self report questionnaires) prior to and post a 10 minute session using the 3D viewer and having a brief pain coping skills training.

Pain Coping Training with 3D viewer

The participant will meet with an interventionist for an hour and a half long session. During this session OA knee pain will be assessed (using self report questionnaires) prior to and post a 10 minute session using the 3D viewer and having a brief pain coping skills training.

Pain Coping Training with 3D viewer

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18-85 years old
  • Have a clinical diagnosis of OA of the knee
  • Be able to read and write English

You may not qualify if:

  • Can't have rheumatoid arthritis, fibromyalgia, or other chronic pain condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center department Psychiatry

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Franicis Keefe, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 15, 2013

Study Start

January 1, 2015

Primary Completion

August 17, 2015

Study Completion

August 17, 2015

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations