Trial Outcomes & Findings for Study of Pain Catastrophizing (NCT NCT03836586)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Day 2

Results posted on

2024-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Pain Catastrophizing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pain Catastrophizing Reduction Group n=5 Participants 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.	Pain Education Group n=5 Participants 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.	Total n=10 Participants Total of all reporting groups
Age, Continuous	56.80 years STANDARD_DEVIATION 6.83 • n=5 Participants	64.20 years STANDARD_DEVIATION 6.14 • n=7 Participants	60.50 years STANDARD_DEVIATION 7.26 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized non-Hispanic Black	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized non-Hispanic White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pain Catastrophizing Reduction Group n=5 Participants 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.	Pain Education Group n=5 Participants 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.
Pain Catastrophizing Scale (PCS) at Day 2	20.40 score on a scale Standard Deviation 25.38	15.25 score on a scale Standard Deviation 16.03

Adverse Events

Pain Catastrophizing Reduction Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pain Education Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ellen Terry

University of Florida

Phone: 352-273-6441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place