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Trial Outcomes & Findings for Treating Chronic Pain in Gulf War Illness (NCT NCT02378025)

NCT ID: NCT02378025

Last Updated: 2020-06-11

Results Overview

Model - estimated change in the Pain Severity subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

Week 10 minus Week 0

Results posted on

2020-06-11

Participant Flow

Participant milestones

Participant milestones
Measure
Yoga Group
Postures, meditation, breathing exercises Yoga Group: A 10-week yoga course designed to treat pain.
Pain Management Wellness Group
Behavioral medicine Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain.
Overall Study
STARTED
39
36
Overall Study
COMPLETED
26
15
Overall Study
NOT COMPLETED
13
21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treating Chronic Pain in Gulf War Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Yoga Group
n=39 Participants
Postures, meditation, breathing exercises Yoga Group: A 10-week yoga course designed to treat pain.
Pain Management Wellness Group
n=36 Participants
Behavioral medicine Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain.
Total
n=75 Participants
Total of all reporting groups
Age, Continuous
53.8 years
STANDARD_DEVIATION 7.2 • n=5 Participants
52.0 years
STANDARD_DEVIATION 6.8 • n=7 Participants
53.0 years
STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
10 Participants
n=7 Participants
18 Participants
n=5 Participants
Sex: Female, Male
Male
31 Participants
n=5 Participants
26 Participants
n=7 Participants
57 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants
n=5 Participants
29 Participants
n=7 Participants
60 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
Asian
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 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
Race (NIH/OMB)
Black or African American
7 Participants
n=5 Participants
4 Participants
n=7 Participants
11 Participants
n=5 Participants
Race (NIH/OMB)
White
16 Participants
n=5 Participants
20 Participants
n=7 Participants
36 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
Region of Enrollment
United States
39 participants
n=5 Participants
36 participants
n=7 Participants
75 participants
n=5 Participants

PRIMARY outcome

Timeframe: Week 10 minus Week 0

Model - estimated change in the Pain Severity subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment

Outcome measures

Outcome measures
Measure
Yoga Group
n=39 Participants
Postures, meditation, breathing exercises Yoga Group: A 10-week yoga course designed to treat pain.
Pain Management Wellness Group
n=36 Participants
Behavioral medicine Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain.
Pain (Brief Pain Inventory - Short Form) - Pain Severity
-.87 units on a scale
Standard Deviation 2.49
-.24 units on a scale
Standard Deviation 2.40

PRIMARY outcome

Timeframe: Week 10 minus Week 0

Population: Note: One participant was not included in this analysis because he discontinued participation in the study before completing this portion of the baseline assessment.

Model - estimated change in the Pain Interference subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment.

Outcome measures

Outcome measures
Measure
Yoga Group
n=39 Participants
Postures, meditation, breathing exercises Yoga Group: A 10-week yoga course designed to treat pain.
Pain Management Wellness Group
n=35 Participants
Behavioral medicine Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain.
Pain (Brief Pain Inventory - Short Form) - Pain Interference
-1.60 units on a scale
Standard Deviation 2.32
-.59 units on a scale
Standard Deviation 2.36

SECONDARY outcome

Timeframe: Week 0, Week 10

Population: Three participants did not complete this assessment at baseline, therefore 72 participants are included in this analysis.

Increase from baseline to end of treatment in distance walked during 6-Minute Walk Test. Greater values indicate more increase and therefore a more positive outcome.

Outcome measures

Outcome measures
Measure
Yoga Group
n=38 Participants
Postures, meditation, breathing exercises Yoga Group: A 10-week yoga course designed to treat pain.
Pain Management Wellness Group
n=34 Participants
Behavioral medicine Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain.
Fatigue (6-Minute Walk Test)
46.4 meters
Standard Deviation 119.0
14.5 meters
Standard Deviation 96.7

SECONDARY outcome

Timeframe: Week 0, Week 10

Population: Week 0 data reflects all participants who responded to the item; some participants left the item blank. Some participants stated that they could not recall all the medications they were taking. Week 10 reflects all participants who completed the Week 10 assessment and answered the item.

Change in number of participants who self-reported use of analgesic medication(s) from Week 0 to Week 10.

Outcome measures

Outcome measures
Measure
Yoga Group
n=35 Participants
Postures, meditation, breathing exercises Yoga Group: A 10-week yoga course designed to treat pain.
Pain Management Wellness Group
n=31 Participants
Behavioral medicine Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain.
Change in Number of Participants Who Used Analgesic Medication
Used at Week 0
2 participants
7 participants
Change in Number of Participants Who Used Analgesic Medication
Used at Week 10
4 participants
5 participants

SECONDARY outcome

Timeframe: Week 0, Week 10

Population: Week 0 data reflects all participants who responded to the item; some participants left the item blank. Some participants stated that they could not recall all the medications they were taking. Week 10 reflects all participants who completed the Week 10 assessment and answered the item.

Change in number of participants who self-reported use of Nonsteroidal Anti-inflammatory Drug(s) from Week 0 to Week 10.

Outcome measures

Outcome measures
Measure
Yoga Group
n=35 Participants
Postures, meditation, breathing exercises Yoga Group: A 10-week yoga course designed to treat pain.
Pain Management Wellness Group
n=31 Participants
Behavioral medicine Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain.
Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs
Used at Week 0
14 Participants
15 Participants
Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs
Used at Week 10
12 Participants
11 Participants

SECONDARY outcome

Timeframe: Week 0, Week 10

Population: Week 0 data reflects all participants who responded to the item; some participants left the item blank. Some participants stated that they could not recall all the medications they were taking. Week 10 reflects all participants who completed the Week 10 assessment and answered the item.

Change in number of participants who self-reported use of Opiate Medication(s) from Week 0 to Week 10.

Outcome measures

Outcome measures
Measure
Yoga Group
n=35 Participants
Postures, meditation, breathing exercises Yoga Group: A 10-week yoga course designed to treat pain.
Pain Management Wellness Group
n=31 Participants
Behavioral medicine Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain.
Change in Number of Participants Who Used Opiate Medication
Participants who used opiates at Week 0
4 Participants
4 Participants
Change in Number of Participants Who Used Opiate Medication
Participants who used opiates at Week 10
5 Participants
5 Participants

Adverse Events

Yoga Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Pain Management Wellness 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. Peter Bayley

Veterans Affairs Palo Alto Healthcare System

Phone: 650 493-5000

Results disclosure agreements

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