From the Guidelines
For a 150-pound patient with chronic lower back pain, moderate disc herniation, and degenerative changes, a multimodal treatment approach is recommended, prioritizing non-pharmacologic therapies with proven benefits, such as spinal manipulation and intensive interdisciplinary rehabilitation, as suggested by the American College of Physicians and the American Pain Society 1.
Initial Treatment Approach
The initial treatment should focus on non-surgical interventions, including physical therapy that emphasizes core strengthening, flexibility, and proper body mechanics. Typically, this involves 2-3 sessions per week for 6-8 weeks.
Pain Management
Pain management may include the use of NSAIDs such as ibuprofen (400-600mg three times daily with food) or naproxen (500mg twice daily with food) for 2-3 weeks. For muscle spasms, muscle relaxants like cyclobenzaprine (5-10mg at bedtime) can be considered. However, it's crucial to note that benzodiazepines, although sometimes used for short-term pain relief, are associated with risks for abuse, addiction, and tolerance, and their use should be limited to a time-limited course of therapy if deemed necessary 1.
Additional Therapies
Activity modification is crucial and includes proper ergonomics, avoiding prolonged sitting, and incorporating gentle movement throughout the day. Heat therapy (20 minutes, 3-4 times daily) and cold packs for acute flare-ups can provide relief. Herbal therapies, such as devil's claw, willow bark, and capsicum, may be considered for acute exacerbations of chronic low back pain, given their safety profile and small to moderate benefits 1.
Advanced Treatment Options
If conservative measures fail after 6-8 weeks, further interventions such as epidural steroid injections may be considered. However, systemic corticosteroids are not recommended for the treatment of low back pain with or without sciatica due to their lack of efficacy compared to placebo 1. Surgery is typically reserved for cases with progressive neurological deficits or failure of conservative treatment over 3-6 months.
Ongoing Management
It's essential to continuously assess the patient's response to treatment and adjust the therapeutic plan as needed. Given the limited evidence on the long-term benefits and risks of medications for low back pain, extended courses of medications should be reserved for patients clearly showing continued benefits from therapy without major adverse events 1.
From the FDA Drug Label
A total of 354 patients (234 duloxetine delayed-release capsules, 120 placebo) were enrolled in Study FM-1 and a total of 520 patients (376 duloxetine delayed-release capsules, 144 placebo) were enrolled in Study FM-2 (5% male, 95% female). The patients had a baseline pain score of 6. 5 on an 11-point scale ranging from 0 (no pain) to 10 (worse possible pain). Studies FM-1 and FM-2 compared duloxetine delayed-release capsules 60 mg once daily or 120 mg daily (given in divided doses in Study FM-1 and as a single daily dose in Study FM-2) with placebo Study FM-2 additionally compared duloxetine delayed-release capsules 20 mg with placebo during the initial three months of a six-month trial. Treatment with duloxetine delayed-release capsules 60 mg or 120 mg daily statistically significantly improved the endpoint mean pain scores from baseline and increased the proportion of patients with at least a 50% reduction in pain score from baseline Pain reduction was observed in patients both with and without comorbid MDD. However, the degree of pain reduction may be greater in patients with comorbid MDD. For various degrees of improvement in pain from baseline to study endpoint, Figures 5 and 6 show the fraction of patients achieving that degree of improvement in Studies FM-1 and FM-2, respectively The figures are cumulative so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the trial were assigned 0% improvement. Some patients experienced a decrease in pain as early as week 1, which persisted throughout the trial Improvement was also demonstrated on measures of function (Fibromyalgia Impact Questionnaires) and patient global impression of change (PGI). Neither trial demonstrated a benefit of 120 mg compared to 60 mg, and a higher dosage was associated with more adverse reactions and premature discontinuations of treatment Figure 5: Percentage of Adult Fibromyalgia Patients Achieving Various Levels of Pain Relief at Study Endpoint as Measured by 24-Hour Average Pain Severity (Study FM-1) Figure 6: Percentage of Adult Fibromyalgia Patients Achieving Various Levels of Pain Relief at Study Endpoint as Measured by 24-Hour Average Pain Severity (Study FM-2) Additionally, the benefit of up-titration in non-responders to duloxetine delayed-release capsules at 60 mg/day was evaluated in a separate trial (Study FM-3). Adult patients were initially treated with duloxetine delayed-release capsules 60 mg once daily for eight weeks in open-label fashion. Subsequently, completers of this phase were randomized to double-blind treatment with duloxetine delayed-release capsules at either 60 mg once daily or 120 mg once daily Responders were defined as patients who had at least a 30% reduction in pain score from baseline at the end of the 8-week treatment Patients who were non-responders at 8 weeks were no more likely to meet response criteria at the end of 60 weeks of treatment if blindly titrated to duloxetine delayed-release capsules 120 mg as compared to those who were blindly continued on duloxetine delayed-release capsules 60 mg. 14. 6 Chronic Musculoskeletal Pain in Adults Duloxetine delayed-release capsules are indicated for the treatment of chronic musculoskeletal pain in adults. This has been established in trials in adult patients with chronic low back pain and chronic pain due to osteoarthritis Trials in Chronic Low Back Pain in Adults The efficacy of duloxetine delayed-release capsules in chronic low back pain (CLBP) in adults was assessed in two double-blind, placebo-controlled, randomized clinical trials of 13-weeks duration (Studies CLBP-1 and CLBP-2), and one of 12-weeks duration (CLBP-3) Studies CLBP-1 and CLBP-3 demonstrated efficacy of duloxetine delayed-release capsules in the treatment of CLBP. Patients in all trials had no signs of radiculopathy or spinal stenosis. Study CLBP-1: Two hundred thirty-six adult patients (N=115 on duloxetine delayed-release capsules, N=121 on placebo) enrolled and 182 (77%) completed 13-week treatment phase After 7 weeks of treatment, duloxetine delayed-release capsules-treated patients with less than 30% reduction in average daily pain and who were able to tolerate 60 mg once daily had their duloxetine delayed-release capsules dosage, in a double-blinded fashion, increased to 120 mg once daily for the remainder of the trial Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). After 13 weeks of treatment, patients taking duloxetine delayed-release capsules 60 to 120 mg daily had a significantly greater pain reduction compared to patients taking placebo. Randomization was stratified by the patients’ baseline NSAIDs use status Subgroup analyses did not indicate that there were differences in treatment outcomes as a function of NSAIDs use Study CLBP-2: Four hundred and four patients were randomized to receive fixed dosages of duloxetine delayed-release capsules daily or a matching placebo (N=59 on duloxetine delayed-release capsules 20 mg, N=116 on duloxetine delayed-release capsules 60 mg, N=112 on duloxetine delayed-release capsules 120 mg, N=117 on placebo) and 267 (66%) completed the entire 13-week trial After 13 weeks of treatment, none of the three duloxetine delayed-release capsules dosages showed a statistically significant difference in pain reduction compared to placebo Study CLBP-3: Four hundred and one patients were randomized to receive fixed doses of duloxetine delayed-release capsules 60 mg daily or placebo (N=198 on duloxetine delayed-release capsules, N=203 on placebo), and 303 (76%) completed the trial. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain) After 12 weeks of treatment, patients taking duloxetine delayed-release capsules 60 mg daily had significantly greater pain reduction compared to patients taking placebo. For various degrees of improvement in pain from baseline to study endpoint, Figures 8 and 9 show the fraction of patients in Studies CLBP-1 and CLBP-3 achieving that degree of improvement, respectively The figures are cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the trial were assigned the value of 0% improvement
The recommended treatment for a 150-pound patient with chronic lower back pain, moderate disc herniation, and degenerative changes is duloxetine delayed-release capsules 60 mg daily.
- The patient's weight is not a factor in determining the dosage.
- Duloxetine delayed-release capsules 60 mg daily has been shown to be effective in reducing pain in patients with chronic low back pain.
- The dosage may be increased to 120 mg daily if the patient does not respond to the initial dosage and can tolerate it.
- It is essential to monitor the patient's response to treatment and adjust the dosage as needed.
- The patient should be informed of the potential benefits and risks of treatment with duloxetine delayed-release capsules 2.
From the Research
Recommended Treatment for a 150-pound Patient with Chronic Lower Back Pain
The patient's weight is not a significant factor in determining the treatment for chronic lower back pain, moderate disc herniation, and degenerative changes. The following are general recommendations for treatment:
- A history and physical examination should be conducted to identify red flags that may indicate serious conditions that warrant immediate intervention or yellow flags that indicate risk of disability 3, 4, 5.
- Nonpharmacologic treatment is first-line management and may include therapies such as counseling, exercise therapy, spinal manipulation, massage, heat, dry needling, acupuncture, transcutaneous electrical nerve stimulation, and physical therapy 3, 4, 5.
- Pharmacologic interventions are second-line treatment, with nonsteroidal anti-inflammatory drugs being the initial medication of choice 3, 4, 5.
- Epidural corticosteroid injections are not recommended except for short-term symptom relief in patients with radicular pain 3, 4, 5.
- Surgery may be considered in patients with persistent functional disabilities and pain from progressive spinal stenosis, worsening spondylolisthesis, or herniated disk 3, 4, 5.
Considerations for Patients with Moderate Disc Herniation and Degenerative Changes
- Patients with moderate disc herniation and degenerative changes may benefit from targeted treatment strategies, such as physical therapy and activity modification 6.
- Lifting-specific behavior modifications focused on improved technique and correcting mobility and muscular imbalances are important aspects of management in patients who want to continue lifting weights 6.
- Validated tools, such as the Oswestry Disability Index, can help assess symptom severity and functional change in patients with chronic low back pain 5.