Trial Outcomes & Findings for Treatment of Veterans With Chronic Low Back Pain (NCT NCT00361270)
NCT ID: NCT00361270
Last Updated: 2018-08-27
Results Overview
The change score measures the difference between Pre-Treatment Brief Pain Inventory Pain Intensity Scale scores (Numerical Rating Scale (NRS): 0 no pain - 10 worst pain) and the 1-week Post--Treatment Brief Pain Inventory-Pain Intensity Scale scores for 4 items. Change is calculated as pre-treatment minus post treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
161 participants
Primary outcome timeframe
Subjects change on this scale from Pre-Treatment to 1 week post treatment
Results posted on
2018-08-27
Participant Flow
Participant milestones
| Measure |
Hypnosis-8
8 sessions of hypnosis with no practice cds
|
Hypnosis-Practice 8
8 sessions hypnosis with practice cds
|
Hypnosis Practice 2
2 sessions of hypnosis with practice cds
|
Biofeedback - 8
8 sessions biofeedback
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
39
|
35
|
38
|
|
Overall Study
COMPLETED
|
25
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
24
|
14
|
10
|
13
|
Reasons for withdrawal
| Measure |
Hypnosis-8
8 sessions of hypnosis with no practice cds
|
Hypnosis-Practice 8
8 sessions hypnosis with practice cds
|
Hypnosis Practice 2
2 sessions of hypnosis with practice cds
|
Biofeedback - 8
8 sessions biofeedback
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
9
|
4
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
3
|
7
|
|
Overall Study
Afraid of Hypnosis
|
1
|
2
|
0
|
0
|
|
Overall Study
Problems with Transportation
|
4
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Treatment of Veterans With Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Arm 1
n=49 Participants
Single-site study at MEDVA-Houston
Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis
|
Arm 2
n=39 Participants
Single-site study at MEDVA-Houston
Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis with home practice with hypnosis CDs
|
Arm 3
n=35 Participants
Single-site study at MEDVA-Houston
Home practice with hypnosis CDs: 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
|
Arm 4
n=38 Participants
Single-site study at MEDVA-Houston
EMG Biofeedback without hypnotic suggestion: 8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
136 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
130 Participants
n=36 Participants
|
|
BPI Pain Intensity
|
24.28 units on a scale
STANDARD_DEVIATION 5.44 • n=93 Participants
|
24.50 units on a scale
STANDARD_DEVIATION 5.52 • n=4 Participants
|
21.08 units on a scale
STANDARD_DEVIATION 5.14 • n=27 Participants
|
25.50 units on a scale
STANDARD_DEVIATION 6.05 • n=483 Participants
|
24.37 units on a scale
STANDARD_DEVIATION 6.26 • n=36 Participants
|
|
BPI Interference
|
61.20 units on a scale
STANDARD_DEVIATION 17.55 • n=93 Participants
|
52.06 units on a scale
STANDARD_DEVIATION 19.62 • n=4 Participants
|
49.60 units on a scale
STANDARD_DEVIATION 20.65 • n=27 Participants
|
11.36 units on a scale
STANDARD_DEVIATION 3.55 • n=483 Participants
|
56.15 units on a scale
STANDARD_DEVIATION 20.15 • n=36 Participants
|
|
PSQI
|
11.36 units on a scale
STANDARD_DEVIATION 3.55 • n=93 Participants
|
11.80 units on a scale
STANDARD_DEVIATION 4.08 • n=4 Participants
|
9.68 units on a scale
STANDARD_DEVIATION 4.15 • n=27 Participants
|
10.24 units on a scale
STANDARD_DEVIATION 4.02 • n=483 Participants
|
11.16 units on a scale
STANDARD_DEVIATION 4.17 • n=36 Participants
|
PRIMARY outcome
Timeframe: Subjects change on this scale from Pre-Treatment to 1 week post treatmentThe change score measures the difference between Pre-Treatment Brief Pain Inventory Pain Intensity Scale scores (Numerical Rating Scale (NRS): 0 no pain - 10 worst pain) and the 1-week Post--Treatment Brief Pain Inventory-Pain Intensity Scale scores for 4 items. Change is calculated as pre-treatment minus post treatment.
Outcome measures
| Measure |
Hypnosis-8
n=25 Participants
8 1-hour sessions of hypnosis without audio recordings
|
Hypnosis-Practice 8
n=25 Participants
8 1-hour sessions of hypnosis with audio recordings
|
Hypnosis Practice 2
n=25 Participants
2 1-hour sessions of hypnosis with audio recordings
|
Biofeedback - 8
n=25 Participants
8 1-hour sessions of EMG biofeedback
|
|---|---|---|---|---|
|
Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale
|
17.52 units on a scale
Standard Deviation 10.24
|
14.16 units on a scale
Standard Deviation 8.78
|
13.78 units on a scale
Standard Deviation 9.04
|
21.18 units on a scale
Standard Deviation 9.22
|
SECONDARY outcome
Timeframe: Subjects change on this scale from Pre-Treatment to 1-week post treatmentThe change score measures the difference between pre-treatment scores on the Brief Pain Inventory-Interference Scale (NRS: 0 no interference - 10 complete interference) and 1- week post treatment scores for the 10 items. Change is calculated as pre-treatment minus post treatment.
Outcome measures
| Measure |
Hypnosis-8
n=25 Participants
8 1-hour sessions of hypnosis without audio recordings
|
Hypnosis-Practice 8
n=25 Participants
8 1-hour sessions of hypnosis with audio recordings
|
Hypnosis Practice 2
n=25 Participants
2 1-hour sessions of hypnosis with audio recordings
|
Biofeedback - 8
n=25 Participants
8 1-hour sessions of EMG biofeedback
|
|---|---|---|---|---|
|
Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale
|
39.08 units on a scale
Standard Deviation 29.39
|
31.88 units on a scale
Standard Deviation 25.66
|
29.00 units on a scale
Standard Deviation 25.99
|
45.4 units on a scale
Standard Deviation 23.67
|
SECONDARY outcome
Timeframe: Subjects change on this scale from Pre-treatment to 1-week post treatmentThe change score is the difference between pre-treatment scores on the Pittsburgh Sleep Quality Index (PSQI) and the 1-week post-treatment scores. Positive values indicate a reduction in sleep problems. The PSQI was scored on 19 items with 7 component scores ranging from 0 no difficulty falling asleep to 3 severe difficulty, then component scores added to create global score ranging from 0 no difficulty falling asleep to 21 severe difficulty falling asleep.
Outcome measures
| Measure |
Hypnosis-8
n=25 Participants
8 1-hour sessions of hypnosis without audio recordings
|
Hypnosis-Practice 8
n=25 Participants
8 1-hour sessions of hypnosis with audio recordings
|
Hypnosis Practice 2
n=25 Participants
2 1-hour sessions of hypnosis with audio recordings
|
Biofeedback - 8
n=25 Participants
8 1-hour sessions of EMG biofeedback
|
|---|---|---|---|---|
|
Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)
|
9.96 units on a scale
Standard Deviation 4.37
|
8.72 units on a scale
Standard Deviation 4.31
|
7.8 units on a scale
Standard Deviation 4.92
|
8.88 units on a scale
Standard Deviation 3.99
|
Adverse Events
Hypnosis-8
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypnosis-Practice 8
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Hypnosis Practice 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Biofeedback - 8
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hypnosis-8
n=49 participants at risk
8 1-hour sessions with hypnotherapist
|
Hypnosis-Practice 8
n=39 participants at risk
8 1-hour sessions with hypnotherapist with audio recordings
|
Hypnosis Practice 2
n=35 participants at risk
2 1-hour sessions with hypnotherapist with audio recordings
|
Biofeedback - 8
n=38 participants at risk
8 1-hour sessions of EMG biofeedback without recordings
|
|---|---|---|---|---|
|
Nervous system disorders
Nightmares
|
0.00%
0/49
|
0.00%
0/39
|
2.9%
1/35 • Number of events 1
|
0.00%
0/38
|
|
Nervous system disorders
Disturbing Images
|
0.00%
0/49
|
2.6%
1/39 • Number of events 1
|
0.00%
0/35
|
0.00%
0/38
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place