Trial Outcomes & Findings for Mind-body Treatments for Chronic Back Pain (NCT NCT03294148)

NCT ID: NCT03294148

Last Updated: 2023-03-22

Results Overview

1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 151 participants
• Primary outcome timeframe: At post-treatment fMRI session, approximately 1 month after randomization
• Results posted on: 2023-03-22

Participant Flow

Participant milestones

Measure	Pain Reprocessing Therapy (PRT) Received psychological treatment	Placebo Open-label placebo	Usual Care Continue usual care
Overall Study STARTED	50	51	50
Overall Study COMPLETED	44	44	47
Overall Study NOT COMPLETED	6	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mind-body Treatments for Chronic Back Pain

Baseline characteristics by cohort

Measure	Pain Reprocessing Therapy (PRT) n=50 Participants Received psychological treatment	Placebo n=51 Participants Open-label placebo	Usual Care n=50 Participants Continue usual care	Total n=151 Participants Total of all reporting groups
Age, Continuous	42.6 years STANDARD_DEVIATION 16.2 • n=5 Participants	39.4 years STANDARD_DEVIATION 14.9 • n=7 Participants	41.3 years STANDARD_DEVIATION 15.9 • n=5 Participants	41.1 years STANDARD_DEVIATION 15.6 • n=4 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	25 Participants n=7 Participants	27 Participants n=5 Participants	81 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	26 Participants n=7 Participants	23 Participants n=5 Participants	70 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	49 Participants n=7 Participants	48 Participants n=5 Participants	147 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	45 Participants n=7 Participants	43 Participants n=5 Participants	134 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Brief Pain Inventory-Short Form (BPI-SF)	1.18 units on a scale Standard Deviation 1.24	2.84 units on a scale Standard Deviation 1.64	3.13 units on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Positive Affect Scale Short Form (PANAS-SF)	17.89 score on a scale Standard Deviation 3.38	15.20 score on a scale Standard Deviation 5.60	14.98 score on a scale Standard Deviation 3.50

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
PROMIS- Depression	12.23 score on a scale Standard Deviation 4.94	11.75 score on a scale Standard Deviation 4.05	11.81 score on a scale Standard Deviation 4.45

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. Scores range from 11-44 with higher scores indicating greater fear of pain, movement, and injury.

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Tampa Scale of Kinesiophobia (TSK)	16.41 score on a scale Standard Deviation 5.37	22.16 score on a scale Standard Deviation 4.94	22.51 score on a scale Standard Deviation 6.30

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire used to help quantify an individual's pain experience. Measured 0-52. A higher score means a higher level of catastrophizing.

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Pain Catastrophizing Questionnaire (PCS)	8.30 score on a scale Standard Deviation 3.04	7.70 score on a scale Standard Deviation 2.44	8.19 score on a scale Standard Deviation 2.75

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks)

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Timeline Follow-Back Measure for Alcohol (TLFB)	11.63 Drinks Standard Deviation 10.83	12.88 Drinks Standard Deviation 14.30	8.02 Drinks Standard Deviation 10.63

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Post-treatment-only outcome measure depicting a patient's subjective rating of overall improvement. Score ranges from 1-7 with a higher score indicating a higher level of change and improvement

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Patient Global Impression of Change (PGIC)	6.14 score on a scale Standard Deviation 0.88	3.61 score on a scale Standard Deviation 1.62	2.06 score on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Post-treatment-only outcome measure depicting the patient's satisfaction with the treatment. Measured 0 - 100. A higher score means higher satisfaction with treatment/

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Treatment Satisfaction Questionnaire	92.40 score on a scale Standard Deviation 8.01	57.61 score on a scale Standard Deviation 23.05	36.86 score on a scale Standard Deviation 23.01

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability.

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Oswestry Disability Index	10.14 score on a scale Standard Deviation 10.63	19.00 score on a scale Standard Deviation 11.07	20.68 score on a scale Standard Deviation 10.68

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire to rate negative affect, scores range from 5 - 25, with a higher score meaning a stronger negative affect

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Negative Affect Scale Short Form (PANAS-SF)	8.30 score on a scale Standard Deviation 3.04	7.70 score on a scale Standard Deviation 2.44	8.19 score on a scale Standard Deviation 2.75

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger.

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
PROMIS Anger	9.52 score on a scale Standard Deviation 3.91	9.89 score on a scale Standard Deviation 3.81	10.45 score on a scale Standard Deviation 3.86

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
PROMIS Sleep	17.73 score on a scale Standard Deviation 6.75	20.50 score on a scale Standard Deviation 6.17	20.89 score on a scale Standard Deviation 6.02

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire measuring anxiety (8 items). Scores range from 8-40 with a higher score meaning more severe levels of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal.

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
PROMIS Anxiety	15.02 score on a scale Standard Deviation 6.16	13.89 score on a scale Standard Deviation 5.78	14.11 score on a scale Standard Deviation 6.99

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks)

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Timeline Follow-Back Measure for Opioid Use (TLFB)	1.29 Opioid pills Standard Deviation 4.50	0.36 Opioid pills Standard Deviation 2.11	1.77 Opioid pills Standard Deviation 8.99

SECONDARY outcome

Timeframe: At post-treatment fMRI session, approximately 1 month after randomization

Population: all available participants analyzed

Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks)

Outcome measures

Measure	Pain Reprocessing Therapy (PRT) n=44 Participants Psychological treatment	Placebo n=44 Participants Open-label placebo	Usual Care n=47 Participants Continue usual care
Timeline Follow-Back Measure for Cannabis (TLFB)	6.76 Grams of cannabis Standard Deviation 25.32	3.31 Grams of cannabis Standard Deviation 6.72	1.49 Grams of cannabis Standard Deviation 3.20

Adverse Events

Pain Reprocessing Therapy (PRT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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. Yoni Ashar

Weill Cornell Medicine

Phone: (646) 962-2820

Email: joa9188@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place