Osteo Arthritis Knee
Conditions
Keywords
catastrophizing, cognitive-behavior therapy
Brief summary
This study proposes to experimentally manipulate pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain among non-Hispanic Blacks (NHBs) and non- Hispanic Whites (NHWs) with knee osteoarthritis (OA). Therefore, participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.
Interventions
BEHAVIORALCognitive-Behavioral Intervention
This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.
BEHAVIORALPain Education
General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.
Sponsors
National Institute on Aging (NIA)
National Institute of Neurological Disorders and Stroke (NINDS)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* symptomatic knee OA
Exclusion criteria
* Younger than 45 years of age or older than 85 years of age * Prosthetic knee replacement or other clinically significant surgery to the arthritic knee * uncontrolled hypertension (\>150/95) * Heart disease including heart failure * Peripheral neuropathy in which pain testing was contraindicated * Systemic rheumatic disorders including rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia * Neurological diseases such as Parkinson's, multiple sclerosis, stroke with loss of sensory or motor function, or uncontrolled seizures * Significantly greater pain in body sites other than in the knee * Daily opioid use * Hospitalization within the preceding year for psychiatric illness * Currently pregnant or nursing/breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale (PCS) at Day 2 | Day 2 | 13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing (Thinking back to your experience during the laboratory pain testing). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pain Catastrophizing Reduction Group This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.
Cognitive-Behavioral Intervention: This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise. | 5 |
| Pain Education Group This group will receive general information about the neurobiology of pain and knee OA.
Pain Education: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Pain Education Group | Total | Pain Catastrophizing Reduction Group |
|---|---|---|---|
| Age, Continuous | 64.20 years STANDARD_DEVIATION 6.14 | 60.50 years STANDARD_DEVIATION 7.26 | 56.80 years STANDARD_DEVIATION 6.83 |
| Race/Ethnicity, Customized non-Hispanic Black | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized non-Hispanic White | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Pain Catastrophizing Scale (PCS) at Day 2
13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing (Thinking back to your experience during the laboratory pain testing). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome.
Time frame: Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Catastrophizing Reduction Group | Pain Catastrophizing Scale (PCS) at Day 2 | 20.40 score on a scale | Standard Deviation 25.38 |
| Pain Education Group | Pain Catastrophizing Scale (PCS) at Day 2 | 15.25 score on a scale | Standard Deviation 16.03 |