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Section 2. Medical science
Akilov Djakhangir Khabibulaevich, assistant of Department of Neurorehabilitation E-mail: akilov.dj@gmail.com Mirdjuraev Elbek Mirshovkatovich, MD., professor, Head of Department of Neurorehabilitaion, Tashkent Institute of Postgraduate Medical Education
E-mail: emmir@bk.ru
EFFICACY OF TRAZODONE IN NON-SPECIFIC BACK PAIN: A RANDOMIZED CONTROLLED TRIAL
Abstract: Antidepressants have been prescribed for the treatment of depression and management of chronic low back pain. However, there is no evidence for their efficacy in non-specific low back pain. This study aimed to examine the efficacy of antidepressant compared with the standard treatments in reducing pain, depression level caused by pain in individuals with non-specific back pain. A randomized controlled trial with 6 weeks follow up of adults with chronic non-specific back pain. Total of 40 patients were recruited, randomized and equally divided into 2 arms: control group and study group. The control group received standard therapy while the study group received an addition of antidepressant trazodone. At 6 weeks, it was found that there was a significant reduction of pain (VAS scale) and a significant decrease in depression(Hamilton rating scale for depression). Hence, this study suggests that Trazodone (Trittico), an antidepressant may be an effective treatment for chronic non-specific back pain.
Keywords: non-specific back pain, depression, lumbalgia, chronic back pain, trazodone, serotonin reuptake inhibitors.
Back pain has contributed to a significant proportion in neurological disorders cases. Among these cases, non-specific low back pain has been reported that it affects people of all ages and is a leading contributor to disease burden worldwide. It is also the second most frequent (after respiratory symptoms) reason for seeking medical attention in developed countries.
Chronic pain is a very costly medical phenomenon. The pain treatments including medical care, employee compensations, and loss of productivity involve more than $100 billion a yearin the United States [1; 5]. Apart from that, depression which leads to loss of productivity, substance abuse and/or suicide has contributedto the society about $43 billion a year. The frequency of depression in the general population ranges from 4% to 8%. When there is chronic pain in individuals, the depression can be 3-4 times higher [3].
Back pain is the most common occurrence among all causes of chronic pain. Non-specific back pain is pain that is not caused by any specific pathology, such as infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammation, radicular syndrome and horsetail syndrome. The episodes of non-specific musculoskeletal pain disturb 60-85% of the population during life [2,3].Generally, the painwears off by itself. About 90% of patients will recover within 6 weeks, however, 7-10% of cases that this pain becomes chronic. It has been established that 25-60% of patients may experience
reoccurrence of chronic back pain within a year after the initial episode. At the same time, over one year, 3-4% of the population is temporarily disabled, and 1% of people ofworking age become disabled due to chronic back pain [1].
Depression in combination with chronic pain may be higher as compared to depression with any other chronic illness. Up to 57% of patients with chronic pain were diagnosed with depression.Persistent or chronic pain seems to be reciprocally associated with depression and anxiety disorders as the chronic pain can lead to long lasting emotional disturbances, low mood state such as depression and anxiety [3].
Depression is a virtually universal complication of intractable pain. When pain prevents patients from doing the things that give them satisfaction and purpose in life, depression is unavoidable. Hence, antidepressants have become a routine adjunctive therapy for most forms of chronic pain. The antidepressants may inhibit of amines, norepinephrine and serotonin in the CNS, which consistently leads to an increase in the activity of the anti-nociceptive system, causing an increase in the pain threshold, mood modification, and lastly providing a reduction in pain.
The effectiveness of antidepressants for the treatment of major depression is well documented; however, the analgesic properties of this class of medication are yet to be indicated. It is important for the patient to understand for which of these
EFFICACY OF TRAZODONE IN NON-SPECIFIC BACK PAIN: A RANDOMIZED CONTROLLED TRIAL
applications an antidepressant is being prescribed. Likewise, it is important that the physician understand that antidepressants can treat both pain and depression [4].
The aim of our study was to determine the effectiveness of modern antidepressants in chronic nonspecific back pain as a comprehensive treatment. Hence, Trazodone, a serotonin reuptake inhibitor was chosen as it has evidence in treating chronic pain, but its effectiveness in non-specific back pain has not been sufficiently studied.
Materials and methods. The study was conducted in the outpatient setting in 1st Tashkent city clinical hospital and Medical Center "Neyrohelp", Tashkent.All adults over 18 years with chronic (> 12 weeks) back pain at the time of inspection with concomitant depression were recruited. According to the criteria of the Cochrane spinal group 2005, patients with concomitant specific diseases of the spine, including ankylosing spondylitis, osteoporosis, spondylo-arthropathy, the presence of radicular compression syndrome, or diseases accompanied by destruction, osteoporosis of the vertebra, severe spinal deformity, the presence of a hernia of an intervertebral disk measuring 1.0 cm or more, sequestered hernias, pseudo-spondilolisthesis above II degree, with signs of myelopathy (according to CT, MRI), infections, tumors, fractures, rheumatoid arthritis, autoimmune processes, rheumatic and other neurological diseases were excluded for this study.
The patients (N = 40) were randomly assigned to either standard treatment with NSAIDs, muscle relaxants, vitamin B complex for 10 days (control group) or standard treatment with addition of Trazodone (Trittico) (study group). The dose of Trazodone (Trittico) was prescribed on a taper-up scale with 50 mg once daily for 7 days followed by 100 mg once daily for 14 days and continue with 150mg once daily for 21 days in order to minimize the side effects.
The primary outcome parameters were mean VAS score for pain assessment and the mean of the Hamilton scale for the depression severity at the end of each week throughout the 6 weeks of treatment.
Both group of patients were comparable as they were matched for age, sex, and clinical indicators. The average age in the recruited patients were 57.2 ± 1.3 years.
Results and discussions. According to the pain score using VAS scale, there was a decrease in both groups at first week. However, the VAS score increased gradually in control group while the score continued to decrease in study group. At 6th week, the VAS score in study group (2.9) showed halved of the score presented in control group (6.05) (Figure 1). Besides, all patients in the study group reported there was an improvement in quality of life throughout the study period.
Weeks i Study ■ Control Figure 1. Pain score (VAS scale)
The assessment of depression using Hamilton scale showed a significant improvement in the mental state in patients of the main group (Figure 2). In patients in the control group, improvement was only observed at the beginning of the examination while receiving standard therapy.
In study group, 45% of the patients (n = 9) experienced some side effects including nausea, headache, weekness,
and drowsiness within first 2 weeks of treatment. 5 patients with drew from the study in between period while the other 4 patients continued the treatment as they have noted the disappearance or significant reduction of the symptomsafter second week of treatment.
Section 2. Medical science
o
o t/5
17,05 16,95 16,35 15,7 15,65 14,25
15,65 13,95 ^^ 13,35 12,95
6,25 5,4
Weeks
-•-Study -«-Control Figure 2. Depression score (Hamilton scale)
Conclusion:
This study showed a reasonable and expedient use of antidepressants as a complex treatment of chronic nonspecific back painas it reduces the pain and the depression symptoms,
providing a long-lasting effect. Hence, this study suggests the use of trazodone in treating nonspecific back pain, in the presence of chronic depression and the absence of intolerance in the patient.
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3. Fishbain D. A., Cutler R., RosomoffH. L., RosomoffR. S. Clin J Chronic pain-associated depression: antecedent or consequence of chronic pain? A review // Clin J Pain, 1997. - Jun. - 13(2). - P. 116-37.
4. Rodieux F., Piguet V., Berney B. et al. Pharmacogenetics and Analgesic Effects of Antidepressants in Chronic Pain Management // Per Med. 2015. - Mar. - 12 (2). - P. 163-75. doi: 10.2217/pme.14.61.
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