Rheumatoid Arthritis Clinical Trial
Official title:
Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Verified date | June 2021 |
Source | Karuna Labs Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs. In phase 1, we will investigate the feasibility, safety, and side effects related to this treatment by assessing simulator sickness. In phase 2, which in contingent on successful completion of phase 1, we will assess symptoms of pain specific to the region treated, fear and avoidance behavior, and depression symptoms before and after 8 sessions of treatment with Virtual Embodiment Therapy in order to assess efficacy. This study will be single-blinded, because the participation of the clinician is necessary to ensure proper administration of the therapy, as well as to monitor in the event of adverse reactions.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Able to understand the English language 2. Have had a chronic central pain of the lower back or upper limbs diagnosis for 3 months or longer 3. Can attend sessions at the study center twice a week for 4 weeks 4. Able to wear a VR HMD (head-mounted display) and move head in cervical rotation, extension, and flexion Exclusion Criteria: 1. Individuals with a history of Severe Mental Illness, including schizophrenia, bipolar disorder I or II, or PTSD 2. History of susceptibility to seizures per subject's reporting 3. Pregnant woman |
Country | Name | City | State |
---|---|---|---|
United States | Remedy Medical Group | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Karuna Labs Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | Safety and feasibility | 1-2 months | |
Primary | Simulator Sickness Questionnaire | The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). The scale measures susceptibility to nausea, general discomfort, stomach awareness, sweating, increased salivation, vertigo, burping, dizziness with eyes open, fullness of head, dizziness with eyes closed, difficulty focusing, headache, blurred vision, fatigue, and eye strain | 1-2 months | |
Primary | Visual Analogue Scale (VAS) | The pain Visual Analogue Scale is a unidimensional measure of pain intensity. Patients are asked to rate the intensity of their pain using a horizontal line 10 centimeters (100 mm) in length. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) | 1-2 months | |
Secondary | Fear and Avoidance Beliefs Questionnaire | The Fear and Avoidance Beliefs Questionnaire is a questionnaire based on the Fear-Avoidance Model of Exaggerated Pain Perception. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear-avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24) | 1-2 months | |
Secondary | OSWESTRY Disability Index Questionnaire | A patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those with low back pain. Questionnaire examines perceived level of disability in 10 everyday activities of daily living concerning the intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. | 1-2months | |
Secondary | Pain Catastrophizing Scale | The Pain Catastrophizing Scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is broken into three subscales being magnification, rumination, and helplessness. The scale was developed as a self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations | 1-2 months | |
Secondary | Patient Health Questionnaire | The Patient Health Questionnaire is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 consists of 9 items of DSM-IV criteria as "0" (not at all) to "3" (nearly every day) | 1-2 months |
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