Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

Depression Clinical Trial

Official title:

Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502644
• Other study ID #: 2007P-001047
• Secondary ID: 5K23DA020681-05
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2011
• Last updated: June 7, 2017
• Start date: February 2009
• Est. completion date: January 2013

Study information

• Verified date: June 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Back Pain
• Chronic Low Back Pain
• Degenerative Disc Disease
• Depression
• Intervertebral Disc Degeneration
• Low Back Pain

Intervention

Drug:
• Oxycodone
Daily dosage up to 120 mg
• Morphine
Daily dosage up to 90 mg immediate release or 180 mg extended release
• Placebo
Placebo-matching oxycodone, placebo-matching morphine

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Arthritis Foundation, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Average Daily Pain Score	Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary. The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks. Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data. For the LMM model, group, group × week, average baseline pain, and opioid use at baseline (yes/no) were entered as fixed effects using an autoregressive covariance structure. Participant, intercept, and week were entered as random effects, using a compound symmetry covariance structure. A positive change from baseline indicates an improvement.	Baseline and Week 20