A Phase 2 interventional study of cognitive behavioral therapy and desipramine hydrochloride in Back Pain, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-11-29.
Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment
This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.
This is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low concentration desipramine (\< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration desipramine + cognitive behavioral therapy; and 4) placebo medication (benzotropine mesylate).
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 142 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
desipramine hydrochloride
Drug: desipramine hydrochloride
cognitive behavioral therapy
Behavioral: cognitive behavioral therapy
desipramine hydrochloride and cognitive behavioral therapy
Drug: desipramine hydrochloride · Behavioral: cognitive behavioral therapy
anticholinergic medication; active placebo
Drug: benztropine mesylate 0.125 mg daily
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Also known as: Anafranil
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
Also known as: Cogentin
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Also known as: Anafranil
Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity
The DDS is self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values.
Time frame: 12 weeks after baseline (or last observation carried forward)
Roland and Morris Disability Questionnaire
This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values.
Time frame: 12 weeks after baseline (or last observation carried forward)
| Milestone | Arm 1 | Arm 2 | Arm 3 | Arm 4 |
|---|---|---|---|---|
| Started | 38 | 34 | 37 | 33 |
| Completed | 27 | 27 | 21 | 24 |
| Not completed | 11 | 7 | 16 | 9 |
| Withdrew: Lost to follow-up | 2 | 2 | 6 | 4 |
| Withdrew: Withdrawal by subject | 6 | 2 | 5 | 3 |
| Withdrew: Adverse event | 3 | 1 | 5 | 2 |
| Withdrew: Protocol violation | 0 | 2 | 0 | 0 |
The DDS is self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values.
| units on a scale | Arm 1 + Arm 3 | Arm 2 + Arm 4 |
|---|---|---|
| Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity | 8.3 ± 0.5 | 8.1 ± 0.6 |
This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values.
| Units on a scale. | Arm 1 + Arm 3 | Arm 2 + Arm 4 |
|---|---|---|
| Roland and Morris Disability Questionnaire | 8.7 ± 0.5 | 8.9 ± 0.5 |
The DDS is self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values.
| units on a scale | Arm 2 + Arm 3 | Arm 1 + Arm 4 |
|---|---|---|
| Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity | 8.0 ± 0.6 | 8.4 ± 0.6 |
This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values.
| Units on a scale. | Arm 2 + Arm 3 | Arm 1 + Arm 4 |
|---|---|---|
| Roland and Morris Disability Questionnaire | 8.7 ± 0.5 | 8.9 ± 0.5 |
Collected over Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 1/38 (2.6%) | 12/17 (70.6%) |
| Arm 2 | — | 0/34 (0%) | 8/20 (40%) |
| Arm 3 | — | 1/37 (2.7%) | 7/16 (43.8%) |
| Arm 4 | — | 0/33 (0%) | 6/17 (35.3%) |
| Event | Arm 1 | Arm 2 | Arm 3 | Arm 4 |
|---|---|---|---|---|
| fallCardiac disorders | 0/38 | 0/34 | 1/37 | 0/33 |
| urosepsisRenal and urinary disorders | 1/38 | 0/34 | 0/37 | 0/33 |
| Event | Arm 1 | Arm 2 | Arm 3 | Arm 4 |
|---|---|---|---|---|
| dry mouthGastrointestinal disorders | 5/17 | 3/20 | 4/16 | 1/17 |
| difficulty urinatingRenal and urinary disorders | 4/17 | 1/20 | 1/16 | 1/17 |
| constipationGastrointestinal disorders | 4/17 | 1/20 | 1/16 | 1/17 |
| erectile dysfunctionRenal and urinary disorders | 3/17 | 0/20 | 0/16 | 3/17 |
| decreased libidoNervous system disorders | 1/17 | 0/20 | 0/16 | 3/17 |
| accomodation disturbanceEye disorders | 2/17 | 0/20 | 2/16 | 1/17 |
| sedationNervous system disorders | 0/17 | 1/20 | 2/16 | 0/17 |
| ejaculatory dysfunctionRenal and urinary disorders | 2/17 | 0/20 | 0/16 | 1/17 |
| orgasm dysfunctionRenal and urinary disorders | 2/17 | 0/20 | 0/16 | 1/17 |
| increased dreamingNervous system disorders | 1/17 | 2/20 | 0/16 | 1/17 |
Demographic characteristics of participants randomized at baseline to one of the four study arms (selected information on three participants missing)
| Age, Continuous(years) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total |
|---|---|---|---|---|---|
| Mean | 56.5 ± 11.7 | 57.8 ± 9.2 | 51.5 ± 13.7 | 57.9 ± 10.9 | 55.8 ± 11.7 |
| Gender(Participants) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total |
|---|---|---|---|---|---|
| Female | 5 | 4 | 3 | 3 | 15 |
| Male | 32 | 29 | 34 | 28 | 123 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 6 | 10 | 5 | 4 | 25 |
| Not Hispanic or Latino | 29 | 22 | 28 | 24 | 103 |
| Unknown or Not Reported | 2 | 1 | 4 | 4 | 11 |
| Race (NIH/OMB)(Participants) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 1 | 0 | 3 |
| Asian | 1 | 1 | 2 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 | 2 |
| Black or African American | 6 | 6 | 4 | 5 | 21 |
| White | 25 | 18 | 21 | 20 | 84 |
| More than one race | 4 | 2 | 7 | 3 | 16 |
| Unknown or Not Reported | 1 | 3 | 1 | 2 | 7 |
| Region of Enrollment(participants) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total |
|---|---|---|---|---|---|
| United States | 37 | 33 | 37 | 32 | 139 |
| Pain Intensity and Back Pain Disability(units on a scale) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total |
|---|---|---|---|---|---|
| Pain Intensity (Descriptor Differential Scale) | 9.9 ± 4.9 | 11.9 ± 4.3 | 11.9 ± 5.1 | 12.1 ± 4.6 | 11.4 ± 4.0 |
| Back Pain Disability (Roland and Morris) | 8.7 ± 5.4 | 13.0 ± 4.3 | 11.7 ± 5.4 | 12.6 ± 3.8 | 11.8 ± 4.9 |
Plan to share: Yes — Available in SPSS format from the investigators.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development