THU0600 Value of Mesotherapy for Treatment of Chronic Low Back Pain: A Randomized Trial

Managing Nontraumatic Acute Back Pain

Cross-cultural translation, adaptation, and psychometric testing. To cross-culturally translate and adapt the Roland-Morris Disability Questionnaire (RMDQ) into Modern Standard Arabic and examine its validity with Arabic-speaking patients with low back pain (LBP). The English RMDQ is valid, reliable, and commonly used to assess LBP disability in clinical practice and research. There is no valid and reliable version of the RMDQ in Modern Standard Arabic. The RMDQ was forward translated and back translated. An expert committee of musculoskeletal physiotherapists reviewed the translation. Eight patients with LBP evaluated item-by-item comprehensibility. Ten patients piloted the RMDQ for overall comprehensibility and acceptability. Seventeen bilingual patients tested the agreement of the Arabic and English RMDQs. Two-hundred one patients completed the RMDQ and the visual analogue scale. Sixty-four patients were followed-up for test-retest reliability. Translation of most items was uncontroversial. The expert committee found the Arabic RMDQ clinically and culturally appropriate. They reviewed item 11, addressing bending and kneeling, because this has a clinical significance and cultural/religious implication regarding prayer positions. All patients reported that it was easy to understand and complete. The Arabic RMDQ had high overall agreement with the English RMDQ for the global score (intraclass correlation coefficient [ICC] = 0.925; 0.811-0.972). Kappa statistics showed good item-by-item agreement (none ≤0.30). Mean (SD) RMDQ and visual analog scale scores of 201 patients were 10.53 (4.80) and 5.11 (2.28), respectively. The RMDQ had a low correlation against pain intensity (r = 0.259; P < 0.01). A Cronbach α of 0.729 showed high internal consistency. Test-retest reliability of the Arabic RMDQ was good (ICC = 0.900; 95% confidence interval, 0.753-0.951). Kappa statistics were high for 18 items and fair for 6. The Arabic version of the RMDQ has good comprehensibility and acceptability, high internal consistency and reliability, low correlation against pain intensity, and good agreement with the English RMDQ. We recommend its use with Arabic-speaking patients with LBP. 3.

Acupuncture has been widely used for acute low back pain (LBP), yet there remains continued controversy regarding its efficacy. Therefore, we aimed to critically evaluate the evidence for acupuncture as an effective treatment for acute LBP. English and Chinese databases were searched for randomized controlled trials (RCTs) that involved acupuncture for acute LBP published up to May 2020. Data on the outcomes of pain intensity, functional status, and analgesic use were extracted. The meta-analysis was performed using the Cochrane Collaboration's RevMan 5.3, and pooled data were expressed as mean differences (MD) with 95% confidence intervals (CIs). Of the 13 eligible RCTs identified, 11 RCTs (involving 707 patients) provided moderate-quality evidence that acupuncture has a statistically significant association with improvements in VAS (visual analog scale) score [MD: -1.75 (95% CI: -2.39, -1.12)]. Two studies indicated that acupuncture did not influence the RMDQ (Roland-Morris Disability Questionnaire) scores more than the control treatment [MD: -2.34 (95% CI: -5.34, 0.67)]. Three studies suggested that acupuncture influenced the ODI (Oswestry Disability Index) scores more than the control treatment [MD: -12.84 (95% CI: -23.94, -1.74)]. Two studies suggested that acupuncture influenced the number of pills more than the control treatment [MD: -3.19 (95% CI: -3.45, -2.92)]. Acupuncture treatment of acute LBP was associated with modest improvements in the VAS score, ODI score, and the number of pills, but not the RMDQ score. Our findings should be considered with caution due to the low power original studies. High-quality trials are needed to assess further the role of acupuncture in the treatment of acute LBP.

Fluoroscopy-guided caudal epidural steroid injection (EDSI) is an option for conservative treatment of low back pain and sciatica; however, repeated exposure to radiation is a concern. With the blind technique, the needle misplacement rate is 30%; hence, ultrasound-guided caudal EDSI is a favored option. To determine the efficacy of ultrasound-guided EDSI for low back pain and sciatica. One hundred and ten patients with low back pain and sciatica who were unresponsive to conservative treatment, were prospectively recruited. Ultrasound-guided caudal EDSI was administered at 0, 3, and 6 weeks. Visual Analog Scale (VAS) score was recorded at 0, 2, 4, 12, and 24 weeks. Patients completed the Roland-Morris Disability Questionnaire (RMDQ) at pre-injection and 24 weeks post-injection. VAS was significantly reduced at 2, 4, 12, and 24 weeks (p< 0.01). At 2, 4, 12, and 24 weeks after injection, 20%, 26%, 74%, and 83% of patients displayed > 50% VAS reduction, respectively. The mean pre-injection RMDQ score was 15 and that post-injection at 24 weeks was 7 (p< 0.01). The majority of patients had > 50% reduction in the RMDQ score. Ultrasound-guided EDSI was safe and efficacious for low back pain and sciatica treatment at the intermediate follow-up.

BackgroundMany methods have been used in to treat low back pain. In this study, we aimed to investigate the efficacy of dexketoprofen alone and in combination with methylprednisolone in the treatment of low back pain in the emergency department using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI).MethodsThis prospective, randomized, single-blind study included 150 patients admitted to the emergency department of a university hospital. Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group D) and those receiving dexketoprofen + methylprednisolone treatment (Group DM). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.ResultsThe VAS scores decreased in both groups at all follow-up evaluations performed throughout the treatment (p = 0.000). The mean VAS score evaluated 48 h after treatment was 1.69 ± 1.71 (Median:1) cm in Group DM and 4.13 ± 2.27 (Median:4) cm in Group D (p = 0.000). The decrease in the ODI score was greater in Group DM than in Group D (p = 0.000).ConclusionDexketoprofen showed analgesic efficacy in the treatment of non-traumatic low back pain and decreased disability. When combined with methylprednisolone, dexketoprofen treatment exhibit a greater analgesic effect and further reduced disability.Trial registrationCurrent Controlled Trials NCT06932367 (Retrospectively registered).Clinical trial numberNot applicable.

62. The use of primary sacroiliac joint fusion for lower back pain due to sacroiliac joint pathology: a systematic review and meta-analysis

BackgroundEffective and cost-effective primary care treatments for low back pain (LBP) are required to reduce the burden of the world’s most disabling condition. This study aimed to compare the clinical effectiveness and cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach to LBP (intervention) with usual general practitioner (GP) care (control).Methods and findingsThis pragmatic, cluster-randomised controlled trial with process evaluation and parallel economic evaluation was conducted in the Hutt Valley, New Zealand. Eight general practices were randomly assigned (stratified by practice size) with a 1:1 ratio to intervention (4 practices; 34 GPs) or control group (4 practices; 29 GPs). Adults presenting to these GPs with LBP as their primary complaint were recruited. GPs in the intervention practices were trained in the FREE approach, and patients presenting to these practices received care based on the FREE approach. The FREE approach restructures LBP consultations to prioritise early identification and management of barriers to recovery. GPs in control practices did not receive specific training for this study, and patients presenting to these practices received usual care. Between 23 September 2016 and 31 July 2017, 140 eligible patients presented to intervention practices (126 enrolled) and 110 eligible patients presented to control practices (100 enrolled). Patient mean age was 46.1 years (SD 14.4), and 46% were female. The duration of LBP was less than 6 weeks in 88% of patients. Primary outcome was change from baseline in patient participant Roland Morris Disability Questionnaire (RMDQ) score at 6 months. Secondary patient outcomes included pain, satisfaction, and psychosocial indices. GP outcomes included attitudes, knowledge, confidence, and GP LBP management behaviour. There was active and passive surveillance of potential harms. Patients and outcome assessors were blind to group assignment. Analysis followed intention-to-treat principles. A total of 122 (97%) patients from 32 GPs in the intervention group and 99 (99%) patients from 25 GPs in the control group were included in the primary outcome analysis. At 6 months, the groups did not significantly differ on the primary outcome (adjusted mean RMDQ score difference 0.57, 95% CI −0.64 to 1.78; p = 0.354) or secondary patient outcomes. The RMDQ difference met the predefined criterion to indicate noninferiority. One control group participant experienced an activity-related gluteal tear, with no other adverse events recorded. Intervention group GPs had improvements in attitudes, knowledge, and confidence compared with control group GPs. Intervention group GP LBP management behaviour became more guideline concordant than the control group. In cost-effectiveness, the intervention dominated control with lower costs and higher Quality-Adjusted Life Year (QALY) gains. Limitations of this study were that although adequately powered for primary outcome assessment, the study was not powered for evaluating some employment, healthcare use, and economic outcomes. It was also not possible for research nurses (responsible for patient recruitment) to be masked on group allocation for practices.ConclusionsFindings from this study suggest that the FREE approach improves GP concordance with LBP guideline recommendations but does not improve patient recovery outcomes compared with usual care. The FREE approach may reduce unnecessary healthcare use and produce economic benefits. Work participation or health resource use should be considered for primary outcome assessment in future trials of undifferentiated LBP.Trial registrationACTRN12616000888460

In this premarket clinical study, we evaluated the efficacy and safety of a novel Hydrogel (HYADD4-G) for reducing low back pain (LBP) in patients with degenerative disc disease (DDD). Twenty-three patients with chronic LBP were enrolled. All patients presented with up to three lumbar black discs (Pfirrmann grade III or IV), LBP of at least 40 mm on the Visual Analogue Scale (VAS), and a Roland-Morris Disability Questionnaire (RMDQ) score of at least 9. Patients received a single 1.5 ml intradiscal injection of HYADD4-G (8 mg/ml), guided by X-ray. Our primary endpoint was the change in VAS score from baseline (day 0) to 4, 12, and 24 weeks. Our secondary endpoints were black disc hydration by Magnetic Resonance Imaging (MRI); the patient's therapeutic response according to the RMDQ; the quality of life, as determined by the EuroQol-5 Dimension (EQ-5D) Index; and a global assessment of patient health status, safety, and local tolerability. Compared with baseline values, VAS score showed a significant reduction at each time point, and across the overall 24-week follow-up period (p < 0.0001). MRI scanning observed a significant reduction in Pfirrmann grade from baseline, by at least one grade, at both week 4 (p = 0.0039) and week 24 (p = 0.0010). Furthermore, compared with baseline values, there was a significant reduction in RMDQ score at each timepoint, and across the entire study period (p < 0.0001). The EQ-5D index increased significantly from baseline to week 24 (p = 0.0001). Finally, mean VAS scores for Patient Global Assessment (PTGA), and Clinical Observer Global Assessment (COGA), decreased significantly at each time point (p < 0.0001), except for week 4. HYADD4-G proved to be an efficient reliever of low back pain due to DDD.

Effects of valdecoxib in the treatment of chronic low back pain: results of a randomized, placebo-controlled trial

ObjectiveTo assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes).DesignDouble blind,...

ObjectivesTo investigate the efficacy of non-surgical and non-interventional treatments for adults with low back pain compared with placebo.Eligibility criteriaRandomised controlled trials evaluating non-surgical and non-interventional treatments compared with placebo or...

Background: To compare the efficiency of transcutaneous electrical nerve stimulation (TENS) with those of exercise and acetaminophen for the treatment of pregnancy-related low back pain (LBP) during the third trimester of pregnancy. Methods: This prospective study included 79 subjects (≥32 gestational weeks) with visual analog scale (VAS) pain scores ≥5. Participants were divided randomly into a control group (n = 21) and three treatment groups [exercise (n = 19); acetaminophen (n = 19); TENS (n = 20)]. The VAS and the Roland-Morris disability questionnaire (RMDQ) were completed before and 3 weeks after treatment to assess the impact of pain on daily activities. Results: During the study period, pain intensity increased in 57% of participants in the control group, whereas pain decreased in 95% of participants in the exercise group and in all participants in the acetaminophen and TENS groups. Post-treatment VAS and RMDQ values were significantly lower in the treatment groups (p < 0.001). VAS and RMDQ scores indicated a significantly greater degree of pain relief in the TENS group than in the exercise and acetaminophen groups (p < 0.001). No adverse effect of TENS application on pregnant women was observed during the study. Conclusion: TENS is an effective and safe treatment modality for LBP during pregnancy. TENS improved LBP more effectively than did exercise and acetaminophen.

For symptomatic relief of low back pain, non-steroidal antiinflammatory drugs (NSAIDs) and analgesics are often in used in combination with muscle relaxants. However adverse effects, especially sedation, limit the use of some muscle relaxants. Thiocolchicoside (TCC) is a non-sedating muscle relaxant that has been shown to be safe and effective as monotherapy in the treatment of this problem. The present study was carried out to determine if the combination of thiocolchicoside and standard treatment is more effective than standard treatment alone. Ninety-three Turkish centers recruited adults presenting with acute and subacute low back pain. Each physician included four patients. Patients were randomized to receive either a NSAID or an analgesic for 5 to 7 days (referred to as “standard treatment”) or standard treatment plus 8 mg TCC (Muscoril) twice daily for 5 to 7 days. On inclusion and again on day 7, low back pain was evaluated with a visual analogue scale (VAS) and disability was evaluated with the Roland-Morris disability questionnaire. Pain and disability were evaluated again on day 31. A total of 155 patients were randomized to receive standard treatment alone and 174 received standardtreatment and TCC. The vast majority (98.2%) of the patients received a NSAID as standard treatment. The mean VAS and disability questionnaire scores of the two groups were equivalent at inclusion. At day 7, patients in both groups were improved but patients receiving TCC had significantly less pain (p<0.003) and disability (p=0.0005) than patients on standard treatment alone; this was also true at day 31. (p<0.005 and p=0.0005, respectively). The addition of TCC to NSAID standard treatment resulted more effective for the symptomatic treatment of low back pain than the NSAID alone. In addition, the combination was well tolerated and produced no more adverse effects than the NSAID alone.

Study DesignRetrospective study.PurposeTo determine whether low-dose tramadol plus non-steroidal anti-inflammatory drug combination therapy could prevent the transition of acute low back pain to chronic low back pain.Overview of LiteratureInadequately treated early low back pain transitions to chronic low back pain occur in approximately 30% of affected individuals. The administration of non-steroidal anti-inflammatory drugs is effective for treatment of low back pain in the early stages. However, the treatment of low back pain that is resistant to non-steroidal anti-inflammatory drugs is challenging.MethodsPatients who presented with acute low back pain at our hospital were considered for inclusion in this study. After the diagnosis of acute low back pain, non-steroidal anti-inflammatory drug administration was started. Forty patients with a visual analog scale score of >5 for low back pain 1 month after treatment were finally enrolled. The first 20 patients were included in a non-steroidal anti-inflammatory drug group, and they continued non-steroidal anti-inflammatory drug therapy for 1 month. The next 20 patients were included in a combination group, and they received low-dose tramadol plus non-steroidal anti-inflammatory drug combination therapy for 1 month. The incidence of adverse events and the improvement in the visual analog scale score at 2 months after the start of treatment were analyzed.ResultsNo adverse events were observed in the non-steroidal anti-inflammatory drug group. In the combination group, administration was discontinued in 2 patients (10%) due to adverse events immediately following the start of tramadol administration. At 2 months, the improvement in the visual analog scale score was greater in the combination group than in the non-steroidal anti-inflammatory drug group (p<0.001).ConclusionsLow-dose tramadol plus non-steroidal anti-inflammatory drug combination therapy might decrease the incidence of adverse events and prevent the transition of acute low back pain to chronic low back pain.

BACKGROUND AND OBJECTIVES: Low back pain is defined as a painful disorder located between the first and the fifth lumbar vertebra, and it is considered to be an important public health problem. In Brazil, approximately 10 million people are disabled as a result of this condition. The objective this study was to assess the effects of the Pilates method on the treatment of chronic low back pain. METHODS: The present study is based on a randomized, controlled clinical trial involving 16 individuals, aged 30-60 years, of both gender, with chronic low back pain, divided into control group and experimental group, with eight individuals each. Twelve sessions of 40 minutes were performed, in which nine positions of the Pilates method were applied within the experimental group. The control group performed kinesiotherapeutic conventional exercises. The visual analog scale and the Oswestry Disability Questionnaire were used before and after the study period in both groups. RESULTS: The assessment of pain and disability in the pre- and post-evaluation periods showed no statistically significant difference. The control group also showed no statistical difference for the visual analog scale and Oswestry scores between the pre- and post-evaluation periods, whereas the experimental group showed a significant difference between the scores obtained in these two different periods for the Oswestry and visual analog scores. CONCLUSION: It is suggested that the method was effective for the group studied and proved to be suitable for the treatment of low back pain, but it did not prove superior to conventional physical therapy.