Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Back Pain, Depression, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 6/9/2017 |
| Start Date: | February 2009 |
| End Date: | January 2013 |
Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness,
such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic
pain patients (and is termed comorbid negative affect [NA]). The purpose of the study is to
determine whether CLBP patients with either a high vs. a low or moderate degree of NA have
different pain relief responses to oral opioids.
such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic
pain patients (and is termed comorbid negative affect [NA]). The purpose of the study is to
determine whether CLBP patients with either a high vs. a low or moderate degree of NA have
different pain relief responses to oral opioids.
The level of high, moderate or low NA was determined based on the participant's score on the
Hospital Anxiety and Depression Scale (HADS). The HADS is a self-reported questionnaire that
has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression
subscale (7 questions). Each item on the questionnaire is scored from 0 (least amount of
anxiety/depression) to 3 (greatest amount of anxiety/depression), with total score between 0
and 21 for either anxiety or depression. Participants were assigned to high, moderate or low
NA groups using the following HADS score criteria:
- High NA = HADS score ≥9 on each subscale
- Moderate NA = HADS score ≥6 to ≤8 on each subscale
- Low NA = HADS score ≤5 on each subscale
Hospital Anxiety and Depression Scale (HADS). The HADS is a self-reported questionnaire that
has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression
subscale (7 questions). Each item on the questionnaire is scored from 0 (least amount of
anxiety/depression) to 3 (greatest amount of anxiety/depression), with total score between 0
and 21 for either anxiety or depression. Participants were assigned to high, moderate or low
NA groups using the following HADS score criteria:
- High NA = HADS score ≥9 on each subscale
- Moderate NA = HADS score ≥6 to ≤8 on each subscale
- Low NA = HADS score ≤5 on each subscale
Inclusion Criteria:
- Low Back Pain > 3/10
- Pain > 1 year
- Degenerative disc disease as seen on magnetic resonance imaging (MRI), which must
meet minimum disc grading criteria: at least a grade III disc degeneration, a
hyperintense zone, or abnormal disc morphology.
- Patients who may have had back surgery will be included.
- No epidural steroids or other nerve blocks for back pain either two weeks before or
during the study period.
- No opioids or on short-acting opioids only (max. daily amount=120 mg morphine
equivalents). It is not feasible to recruit only opioid naive patients.
- Must agree to 2-week washout for those on opioids.
- No active substance abuse.
- No intention to take new pain or psychiatric treatments during the study, including
chiropractic, physical therapy, or complementary or alternative treatments (CAM). It
is not feasible to take participants off of any other pain medications, such as
nonsteroidal anti-inflammatory drugs (NSAIDS).
- No pregnancy or the intent to become pregnant during the study, and no nursing
mothers.
- Women, who are able to bear children, must agree to use contraceptives throughout the
study.
- In men, normal baseline testosterone levels.
Exclusion Criteria:
- Patients with pain due to disorders not including a component of disc degeneration,
or those with unknown causes of pain will be excluded.
- Patients with the intent to undergo back surgery will be excluded.
- Patients with a history of recent or ongoing alcohol or other drug addiction
disorders will be excluded.
- Patients with any history of substance abuse of opioids will be excluded.
- Patients whose diagnosis cannot be firmly established according to criteria described
above would not be included.
- Patients whose medical and psychiatric comorbidities are not well controlled, or who
are currently experiencing an acute exacerbation of the medical comorbidity, will be
excluded.
- Males with abnormal testosterone levels will be excluded (normal range is 1800-6650
pg/ml).
- Female patients who nursing will be excluded.
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