BACKGROUND: This is an update of a Cochrane Review published in 2014. Chronic non-specific low back pain (LBP) has become one of the main causes of disability in the adult population around the world. Although therapeutic ultrasound is not recommended in recent clinical guidelines, it is frequently used by physiotherapists in the treatment of chronic LBP.
OBJECTIVES: The objective of this review was to determine the effectiveness of therapeutic ultrasound in the management of chronic non-specific LBP. A secondary objective was to determine the most effective dosage and intensity of therapeutic ultrasound for chronic LBP.
SEARCH METHODS: We performed electronic searches in CENTRAL, MEDLINE, Embase, CINAHL, PEDro, Index to Chiropractic Literature, and two trials registers to 7 January 2020. We checked the reference lists of eligible studies and relevant systematic reviews and performed forward citation searching.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) on therapeutic ultrasound for chronic non-specific LBP. We compared ultrasound (either alone or in combination with another treatment) with placebo or other interventions for chronic LBP.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the risk of bias of each trial and extracted the data. We performed a meta-analysis when sufficient clinical and statistical homogeneity existed. We determined the certainty of the evidence for each comparison using the GRADE approach.
MAIN RESULTS: We included 10 RCTs involving a total of 1025 participants with chronic LBP. The included studies were carried out in secondary care settings in Turkey, Iran, Saudi Arabia, Croatia, the UK, and the USA, and most applied therapeutic ultrasound in addition to another treatment, for six to 18 treatment sessions. The risk of bias was unclear in most studies. Eight studies (80%) had unclear or high risk of selection bias; no studies blinded care providers to the intervention; and only five studies (50%) blinded participants. There was a risk of selective reporting in eight studies (80%), and no studies adequately assessed compliance with the intervention. There was very low-certainty evidence (downgraded for imprecision, inconsistency, and limitations in design) of little to no difference between therapeutic ultrasound and placebo for short-term pain improvement (mean difference (MD) -7.12, 95% confidence interval (CI) -17.99 to 3.75; n = 121, 3 RCTs; 0-to-100-point visual analogue scale (VAS)). There was also moderate-certainty evidence (downgraded for imprecision) of little to no difference in the number of participants achieving a 30% reduction in pain in the short term (risk ratio 1.08, 95% CI 0.81 to 1.44; n = 225, 1 RCT). There was low-certainty evidence (downgraded for imprecision and limitations in design) that therapeutic ultrasound has a small effect on back-specific function compared with placebo in the short term (standardised mean difference -0.29, 95% CI -0.51 to -0.07 (MD -1.07, 95% CI -1.89 to -0.26; Roland Morris Disability Questionnaire); n = 325; 4 RCTs), but this effect does not appear to be clinically important. There was moderate-certainty evidence (downgraded for imprecision) of little to no difference between therapeutic ultrasound and placebo on well-being (MD -2.71, 95% CI -9.85 to 4.44; n = 267, 2 RCTs; general health subscale of the 36-item Short Form Health Survey (SF-36)). Two studies (n = 486) reported on overall improvement and satisfaction between groups, and both reported little to no difference between groups (low-certainty evidence, downgraded for serious imprecision). One study (n = 225) reported on adverse events and did not identify any adverse events related to the intervention (low-certainty evidence, downgraded for serious imprecision). No study reported on disability for this comparison. We do not know whether therapeutic ultrasound in addition to exercise results in better outcomes than exercise alone because the certainty of the evidence for all outcomes was very low (downgraded for imprecision and serious limitations in design). The estimate effect for pain was in favour of the ultrasound plus exercise group (MD -21.1, 95% CI -27.6 to -14.5; n = 70, 2 RCTs; 0-to-100-point VAS) at short term. Regarding back-specific function (MD - 0.41, 95% CI -3.14 to 2.32; n = 79, 2 RCTs; Oswestry Disability Questionnaire) and well-being (MD -2.50, 95% CI -9.53 to 4.53; n = 79, 2 RCTs; general health subscale of the SF-36), there was little to no difference between groups at short term. No studies reported on the number of participants achieving a 30% reduction in pain, patient satisfaction, disability, or adverse events for this comparison.
AUTHORS' CONCLUSIONS: The evidence from this systematic review is uncertain regarding the effect of therapeutic ultrasound on pain in individuals with chronic non-specific LBP. Whilst there is some evidence that therapeutic ultrasound may have a small effect on improving low back function in the short term compared to placebo, the certainty of evidence is very low. The true effect is likely to be substantially different. There are few high-quality randomised trials, and the available trials were very small. The current evidence does not support the use of therapeutic ultrasound in the management of chronic LBP.
OBJECTIVE: To evaluate the effectiveness of Pilates exercise in people with chronic low back pain (CLBP) through a systematic review of randomised controlled trials (RCTs).
DATA SOURCES: A search for RCTs was undertaken using Medical Search Terms and synonyms for "Pilates" and "low back pain" within the maximal date range of 10 databases. Databases included the Cumulative Index to Nursing and Allied Health Literature; Cochrane Library; Medline; Physiotherapy Evidence Database; ProQuest: Health and Medical Complete, Nursing and Allied Health Source, Dissertation and Theses; Scopus; Sport Discus; Web of Science.
STUDY SELECTION: Two independent reviewers were involved in the selection of evidence. To be included, relevant RCTs needed to be published in the English language. From 152 studies, 14 RCTs were included.
DATA EXTRACTION: Two independent reviewers appraised the methodological quality of RCTs using the McMaster Critical Review Form for Quantitative Studies. The author(s), year of publication, and details regarding participants, Pilates exercise, comparison treatments, and outcome measures, and findings, were then extracted.
DATA SYNTHESIS: The methodological quality of RCTs ranged from "poor" to "excellent". A meta-analysis of RCTs was not undertaken due to the heterogeneity of RCTs. Pilates exercise provided statistically significant improvements in pain and functional ability compared to usual care and physical activity between 4 and 15 weeks, but not at 24 weeks. There were no consistent statistically significant differences in improvements in pain and functional ability with Pilates exercise, massage therapy, or other forms of exercise at any time period.
CONCLUSIONS: Pilates exercise offers greater improvements in pain and functional ability compared to usual care and physical activity in the short term. Pilates exercise offers equivalent improvements to massage therapy and other forms of exercise. Future research should explore optimal Pilates exercise designs, and whether some people with CLBP may benefit from Pilates exercise more than others.
BACKGROUND: Low back pain (LBP) is responsible for considerable personal suffering worldwide. Those with persistent disabling symptoms also contribute to substantial costs to society via healthcare expenditure and reduced work productivity. While there are many treatment options, none are universally endorsed. The idea that chronic LBP is a condition best understood with reference to an interaction of physical, psychological and social influences, the 'biopsychosocial model', has received increasing acceptance. This has led to the development of multidisciplinary biopsychosocial rehabilitation (MBR) programs that target factors from the different domains, administered by healthcare professionals from different backgrounds.
OBJECTIVES: To review the evidence on the effectiveness of MBR for patients with chronic LBP. The focus was on comparisons with usual care and with physical treatments measuring outcomes of pain, disability and work status, particularly in the long term.
SEARCH METHODS: We searched the CENTRAL, MEDLINE, EMBASE, PsycINFO and CINAHL databases in January and March 2014 together with carrying out handsearches of the reference lists of included and related studies, forward citation tracking of included studies and screening of studies excluded in the previous version of this review.
SELECTION CRITERIA: All studies identified in the searches were screened independently by two review authors; disagreements regarding inclusion were resolved by consensus. The inclusion criteria were published randomised controlled trials (RCTs) that included adults with non-specific LBP of longer than 12 weeks duration; the index intervention targeted at least two of physical, psychological and social or work-related factors; and the index intervention was delivered by clinicians from at least two different professional backgrounds.
DATA COLLECTION AND ANALYSIS: Two review authors extracted and checked information to describe the included studies, assessed risk of bias and performed the analyses. We used the Cochrane risk of bias tool to describe the methodological quality. The primary outcomes were pain, disability and work status, divided into the short, medium and long term. Secondary outcomes were psychological functioning (for example depression, anxiety, catastrophising), healthcare service utilisation, quality of life and adverse events. We categorised the control interventions as usual care, physical treatment, surgery, or wait list for surgery in separate meta-analyses. The first two comparisons formed our primary focus. We performed meta-analyses using random-effects models and assessed the quality of evidence using the GRADE method. We performed sensitivity analyses to assess the influence of the methodological quality, and subgroup analyses to investigate the influence of baseline symptom severity and intervention intensity.
MAIN RESULTS: From 6168 studies identified in the searches, 41 RCTs with a total of 6858 participants were included. Methodological quality ratings ranged from 1 to 9 out 12, and 13 of the 41 included studies were assessed as low risk of bias. Pooled estimates from 16 RCTs provided moderate to low quality evidence that MBR is more effective than usual care in reducing pain and disability, with standardised mean differences (SMDs) in the long term of 0.21 (95% CI 0.04 to 0.37) and 0.23 (95% CI 0.06 to 0.4) respectively. The range across all time points equated to approximately 0.5 to 1.4 units on a 0 to 10 numerical rating scale for pain and 1.4 to 2.5 points on the Roland Morris disability scale (0 to 24). There was moderate to low quality evidence of no difference on work outcomes (odds ratio (OR) at long term 1.04, 95% CI 0.73 to 1.47). Pooled estimates from 19 RCTs provided moderate to low quality evidence that MBR was more effective than physical treatment for pain and disability with SMDs in the long term of 0.51 (95% CI -0.01 to 1.04) and 0.68 (95% CI 0.16 to 1.19) respectively. Across all time points this translated to approximately 0.6 to 1.2 units on the pain scale and 1.2 to 4.0 points on the Roland Morris scale. There was moderate to low quality evidence of an effect on work outcomes (OR at long term 1.87, 95% CI 1.39 to 2.53). There was insufficient evidence to assess whether MBR interventions were associated with more adverse events than usual care or physical interventions.
Sensitivity analyses did not suggest that the pooled estimates were unduly influenced by the results from low quality studies. Subgroup analyses were inconclusive regarding the influence of baseline symptom severity and intervention intensity.
AUTHORS' CONCLUSIONS: Patients with chronic LBP receiving MBR are likely to experience less pain and disability than those receiving usual care or a physical treatment. MBR also has a positive influence on work status compared to physical treatment. Effects are of a modest magnitude and should be balanced against the time and resource requirements of MBR programs. More intensive interventions were not responsible for effects that were substantially different to those of less intensive interventions. While we were not able to determine if symptom intensity at presentation influenced the likelihood of success, it seems appropriate that only those people with indicators of significant psychosocial impact are referred to MBR.
OBJECTIVES: Although acupuncture has been frequently used for acute nonspecific low back pain (LBP), relevant systematic reviews indicate sparse and inconclusive evidence. This systematic review aimed at critically evaluating the evidence for/against acupuncture for acute LBP.
METHODS: We searched Medline, Central, Embase, 2 Chinese databases, relevant journals, and trial registries for the randomized-controlled trials of acupuncture that involved needling for acute/subacute LBP. Risk of bias was assessed using the assessment tool from the Cochrane Back Review Group and the adequacy of acupuncture intervention was evaluated by 2 independent reviewers. The studies according to the control types were combined using a random-effects model.
RESULTS: A total of 11 randomized-controlled trials (n=1139) were included. Compared with nonsteroidal anti-inflammatory drugs, acupuncture may more effectively improve symptoms of acute LBP (5 studies; risk ratio, 1.11; 95% confidence interval: 1.06, 1.16). For pain, there exists inconsistent evidence that acupuncture is more effective than medication. Compared with sham acupuncture, acupuncture may more effectively relieve pain (2 studies; mean difference, -9.38; 95% confidence interval: -17.00, -1.76) but not function/disability. Acupuncture appears to be associated with few side effects but the evidence is limited.
DISCUSSION: The current evidence is encouraging in that acupuncture may be more effective than medication for symptom improvement or relieve pain better than sham acupuncture in acute LBP. The present findings should be confirmed by future studies that overcome the methodological limitations of the studies evaluated in our review.
STUDY DESIGN: A systematic review and meta-analysis of randomized controlled trials (RCTs). OBJECTIVE: To evaluate the totality of evidence in relation to the effectiveness of acupuncture for nonspecific chronic low back pain (NSCLBP). SUMMARY OF BACKGROUND DATA: Acupuncture has become a popular alternative for treating clinical symptoms of NSCLBP. A number of RCTs have examined the effectiveness of acupuncture in the treatment of NSCLBP. METHODS: A systematic literature search was completed without date or language restrictions up to May 2012. Studies included in the review were RCTs that examined all forms of acupuncture that adhered to the Traditional Acupuncture Theory for treating NSCLBP. Outcome measures included impairment, activity limitation, and participation restriction. The methodological quality of the studies was examined using the Cochrane risk of bias tool. RESULTS: Thirty-two studies were included in the systematic review, of which 25 studies presented relevant data for the meta-analysis. Acupuncture had a clinically meaningful reduction in levels of self-reported pain (mean difference =-16.76 [95% confidence interval, -33.33 to -0.19], P = 0.05, I = 90%) when compared with sham, and improved function (standard mean difference =-0.94 [95% confidence interval, -1.41 to -0.47], P < 0.00, I = 78%) when compared with no treatment immediately postintervention. Levels of function also clinically improved when acupuncture in addition to usual care, or electroacupuncture was compared with usual care alone. When acupuncture was compared with medications (NSAIDs, muscle relaxants, and analgesics) and usual care, there were statistically significant differences between the control and the intervention groups but these differences were too small to be of any clinical significance. There was no evidence in support of acupuncture over transcutaneous electrical nerve stimulation. CONCLUSION: This systematic review demonstrates that acupuncture may have a favorable effect on self-reported pain and functional limitations on NSCLBP. However, the results should be interpreted in the context of the limitations identified, particularly in relation to the heterogeneity in the study characteristics and the low methodological quality in many of the included studies.Level of Evidence: 1.
BACKGROUND: Traction has been used to treat low-back pain (LBP), often in combination with other treatments. We included both manual and machine-delivered traction in this review. This is an update of a Cochrane review first published in 1995, and previously updated in 2006.
OBJECTIVES: To assess the effects of traction compared to placebo, sham traction, reference treatments and no treatment in people with LBP.
SEARCH METHODS: We searched the Cochrane Back Review Group Specialized Register, the Cochrane Central Register of Controlled Trials (2012, Issue 8), MEDLINE (January 2006 to August 2012), EMBASE (January 2006 to August 2012), CINAHL (January 2006 to August 2012), and reference lists of articles and personal files. The review authors are not aware of any important new randomized controlled trial (RCTs) on this topic since the date of the last search.
SELECTION CRITERIA: RCTs involving traction to treat acute (less than four weeks' duration), subacute (four to 12 weeks' duration) or chronic (more than 12 weeks' duration) non-specific LBP with or without sciatica.
DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. As there were insufficient data for statistical pooling, we performed a descriptive analysis. We did not find any case series that identified adverse effects, therefore we evaluated adverse effects that were reported in the included studies.
MAIN RESULTS: We included 32 RCTs involving 2762 participants in this review. We considered 16 trials, representing 57% of all participants, to have a low risk of bias based on the Cochrane Back Review Group's 'Risk of bias' tool.
For people with mixed symptom patterns (acute, subacute and chronic LBP with and without sciatica), there was low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status, global improvement or return to work when compared to placebo, sham traction or no treatment. Similarly, when comparing the combination of physiotherapy plus traction with physiotherapy alone or when comparing traction with other treatments, there was very-low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status or global improvement.
For people with LBP with sciatica and acute, subacute or chronic pain, there was low- to moderate-quality evidence that traction probably has no impact on pain intensity, functional status or global improvement. This was true when traction was compared with controls and other treatments, as well as when the combination of traction plus physiotherapy was compared with physiotherapy alone. No studies reported the effect of traction on return to work.
For chronic LBP without sciatica, there was moderate-quality evidence that traction probably makes little or no difference in pain intensity when compared with sham treatment. No studies reported on the effect of traction on functional status, global improvement or return to work.
Adverse effects were reported in seven of the 32 studies. These included increased pain, aggravation of neurological signs and subsequent surgery. Four studies reported that there were no adverse effects. The remaining studies did not mention adverse effects.
AUTHORS' CONCLUSIONS: These findings indicate that traction, either alone or in combination with other treatments, has little or no impact on pain intensity, functional status, global improvement and return to work among people with LBP. There is only limited-quality evidence from studies with small sample sizes and moderate to high risk of bias. The effects shown by these studies are small and are not clinically relevant.
BACKGROUND: The use of opioids in the long-term management of chronic low-back pain (CLBP) has increased dramatically. Despite this trend, the benefits and risks of these medications remain unclear. This review is an update of a Cochrane review first published in 2007.
OBJECTIVES: To determine the efficacy of opioids in adults with CLBP.
SEARCH METHODS: We electronically searched the Cochrane Back Review Group's Specialized Register, CENTRAL, CINAHL and PsycINFO, MEDLINE, and EMBASE from January 2006 to October 2012. We checked the reference lists of these trials and other relevant systematic reviews for potential trials for inclusion.
SELECTION CRITERIA: We included randomized controlled trials (RCTs) that assessed the use of opioids (as monotherapy or in combination with other therapies) in adults with CLBP that were at least four weeks in duration. We included trials that compared non-injectable opioids to placebo or other treatments. We excluded trials that compared different opioids only.
DATA COLLECTION AND ANALYSIS: Two authors independently assessed the risk of bias and extracted data onto a pre-designed form. We pooled results using Review Manager (RevMan) 5.2. We reported on pain and function outcomes using standardized mean difference (SMD) or risk ratios with 95% confidence intervals (95% CI). We used absolute risk difference (RD) with 95% CI to report adverse effects.
MAIN RESULTS: We included 15 trials (5540 participants). Tramadol was examined in five trials (1378 participants); it was found to be better than placebo for pain (SMD -0.55, 95% CI -0.66 to -0.44; low quality evidence) and function (SMD -0.18, 95% CI -0.29 to -0.07; moderate quality evidence). Transdermal buprenorphine (two trials, 653 participants) may make little difference for pain (SMD -2.47, 95%CI -2.69 to -2.25; very low quality evidence), but no difference compared to placebo for function (SMD -0.14, 95%CI -0.53 to 0.25; very low quality evidence). Strong opioids (morphine, hydromorphone, oxycodone, oxymorphone, and tapentadol), examined in six trials (1887 participants), were better than placebo for pain (SMD -0.43, 95%CI -0.52 to -0.33; moderate quality evidence) and function (SMD -0.26, 95% CI -0.37 to -0.15; moderate quality evidence). One trial (1583 participants) demonstrated that tramadol may make little difference compared to celecoxib (RR 0.82, 95% CI 0.76 to 0.90; very low quality evidence) for pain relief. Two trials (272 participants) found no difference between opioids and antidepressants for either pain (SMD 0.21, 95% CI -0.03 to 0.45; very low quality evidence), or function (SMD -0.11, 95% -0.63 to 0.42; very low quality evidence). The included trials in this review had high drop-out rates, were of short duration, and had limited interpretability of functional improvement. They did not report any serious adverse effects, risks (addiction or overdose), or complications (sleep apnea, opioid-induced hyperalgesia, hypogonadism). In general, the effect sizes were medium for pain and small for function.
AUTHORS' CONCLUSIONS: There is some evidence (very low to moderate quality) for short-term efficacy (for both pain and function) of opioids to treat CLBP compared to placebo. The very few trials that compared opioids to non-steroidal anti-inflammatory drugs (NSAIDs) or antidepressants did not show any differences regarding pain and function. The initiation of a trial of opioids for long-term management should be done with extreme caution, especially after a comprehensive assessment of potential risks. There are no placebo-RCTs supporting the effectiveness and safety of long-term opioid therapy for treatment of CLBP.
STUDY DESIGN: Meta-analysis of randomized, controlled trials.
OBJECTIVE: To determine the short-term, intermediate, and long-term effectiveness of MCE, with regard to pain and disability, in patients with chronic and recurrent low-back pain.
SUMMARY OF BACKGROUND DATA: Previous meta-analyses have shown no difference between the effects of MCE and general exercise in the treatment of low back pain. Several high quality studies on this topic have been published lately, warranting a new meta-analysis.
METHODS: We searched electronic databases up to October 2011 for randomized controlled trials clearly distinguishing MCE from other treatments. We extracted pain and disability outcomes and converted them to a 0 to 100 scale. We used the RevMan5 (Nordic Cochrane Centre, Copenhagen, Denmark) software to perform pooled analyses to determine the weighted mean differences (WMDs) between MCE and 5 different control interventions.
RESULTS: Sixteen studies were included. The pooled results favored MCE compared with general exercise with regard to disability during all time periods (improvement in WMDs ranged from -4.65 to -4.86), and with regard to pain in the short and intermediate term (WMDs were -7.80 and -6.06, respectively). Compared with spinal manual therapy, MCE was superior with regard to disability during all time periods (the WMDs ranged between -5.27 and -6.12), but not with regard to pain. Furthermore, MCE was superior to minimal intervention during all time periods with regard to both pain (the WMDs ranged between -10.18 and -13.32) and disability (the WMDs ranged between -5.62 and -9.00).
CONCLUSION: In patients with chronic and recurrent low back pain, MCE seem to be superior to several other treatments. More studies are, however, needed to investigate what subgroups of patients experiencing LBP respond best to MCE.
OBJECTIVES: : To systematically review and meta-analyze the effectiveness of yoga for low back pain. METHODS: : MEDLINE, the Cochrane Library, EMBASE, CAMBASE, and PsycINFO, were screened through January 2012. Randomized controlled trials comparing yoga to control conditions in patients with low back pain were included. Two authors independently assessed risk of bias using the risk of bias tool recommended by the Cochrane Back Review Group. Main outcome measures were pain, back-specific disability, generic disability, health-related quality of life, and global improvement. For each outcome, standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated. RESULTS: : Ten randomized controlled trials with a total of 967 chronic low back pain patients were included. Eight studies had low risk of bias. There was strong evidence for short-term effects on pain (SMD=-0.48; 95% CI, -0.65 to -0.31; P<0.01), back-specific disability (SMD=-0.59; 95% CI, -0.87 to -0.30; P<0.01), and global improvement (risk ratio=3.27; 95% CI, 1.89-5.66; P<0.01). There was strong evidence for a long-term effect on pain (SMD=-0.33; 95% CI, -0.59 to -0.07; P=0.01) and moderate evidence for a long-term effect on back-specific disability (SMD=-0.35; 95% CI, -0.55 to -0.15; P<0.01). There was no evidence for either short-term or long-term effects on health-related quality of life. Yoga was not associated with serious adverse events. DISCUSSION: : This systematic review found strong evidence for short-term effectiveness and moderate evidence for long-term effectiveness of yoga for chronic low back pain in the most important patient-centered outcomes. Yoga can be recommended as an additional therapy to chronic low back pain patients.
BACKGROUND: Many therapies exist for the treatment of low-back pain including spinal manipulative therapy (SMT), which is a worldwide, extensively practised intervention. This report is an update of the earlier Cochrane review, first published in January 2004 with the last search for studies up to January 2000.
OBJECTIVES: To examine the effects of SMT for acute low-back pain, which is defined as pain of less than six weeks duration.
SEARCH METHODS: A comprehensive search was conducted on 31 March 2011 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PEDro, and the Index to Chiropractic Literature. Other search strategies were employed for completeness. No limitations were placed on language or publication status.
SELECTION CRITERIA: Randomized controlled trials (RCTs) which examined the effectiveness of spinal manipulation or mobilization in adults with acute low-back pain were included. In addition, studies were included if the pain was predominantly in the lower back but the study allowed mixed populations, including participants with radiation of pain into the buttocks and legs. Studies which exclusively evaluated sciatica were excluded. No other restrictions were placed on the setting nor the type of pain. The primary outcomes were back pain, back-pain specific functional status, and perceived recovery. Secondary outcomes were return-to-work and quality of life. SMT was defined as any hands-on therapy directed towards the spine, which includes both manipulation and mobilization, and includes studies from chiropractors, manual therapists, and osteopaths.
DATA COLLECTION AND ANALYSIS: Two review authors independently conducted the study selection and risk of bias (RoB) assessment. Data extraction was checked by the second review author. The effects were examined in the following comparisons: SMT versus 1) inert interventions, 2) sham SMT, 3) other interventions, and 4) SMT as an additional therapy. In addition, we examined the effects of different SMT techniques compared to one another. GRADE was used to assess the quality of the evidence. Authors were contacted, where possible, for missing or unclear data. Outcomes were evaluated at the following time intervals: short-term (one week and one month), intermediate (three to six months), and long-term (12 months or longer). Clinical relevance was defined as: 1) small, mean difference (MD) < 10% of the scale or standardized mean difference (SMD) < 0.4; 2) medium, MD = 10% to 20% of the scale or SMD = 0.41 to 0.7; and 3) large, MD > 20% of the scale or SMD > 0.7.
MAIN RESULTS: We identified 20 RCTs (total number of participants = 2674), 12 (60%) of which were not included in the previous review. Sample sizes ranged from 36 to 323 (median (IQR) = 108 (61 to 189)). In total, six trials (30% of all included studies) had a low RoB. At most, three RCTs could be identified per comparison, outcome, and time interval; therefore, the amount of data should not be considered robust. In general, for the primary outcomes, there is low to very low quality evidence suggesting no difference in effect for SMT when compared to inert interventions, sham SMT, or when added to another intervention. There was varying quality of evidence (from very low to moderate) suggesting no difference in effect for SMT when compared with other interventions, with the exception of low quality evidence from one trial demonstrating a significant and moderately clinically relevant short-term effect of SMT on pain relief when compared to inert interventions, as well as low quality evidence demonstrating a significant short-term and moderately clinically relevant effect of SMT on functional status when added to another intervention. In general, side-lying and supine thrust SMT techniques demonstrate a short-term significant difference when compared to non-thrust SMT techniques for the outcomes of pain, functional status, and recovery.
AUTHORS' CONCLUSIONS: SMT is no more effective in participants with acute low-back pain than inert interventions, sham SMT, or when added to another intervention. SMT also appears to be no better than other recommended therapies. Our evaluation is limited by the small number of studies per comparison, outcome, and time interval. Therefore, future research is likely to have an important impact on these estimates. The decision to refer patients for SMT should be based upon costs, preferences of the patients and providers, and relative safety of SMT compared to other treatment options. Future RCTs should examine specific subgroups and include an economic evaluation.
This is an update of a Cochrane Review published in 2014. Chronic non-specific low back pain (LBP) has become one of the main causes of disability in the adult population around the world. Although therapeutic ultrasound is not recommended in recent clinical guidelines, it is frequently used by physiotherapists in the treatment of chronic LBP.
OBJECTIVES:
The objective of this review was to determine the effectiveness of therapeutic ultrasound in the management of chronic non-specific LBP. A secondary objective was to determine the most effective dosage and intensity of therapeutic ultrasound for chronic LBP.
SEARCH METHODS:
We performed electronic searches in CENTRAL, MEDLINE, Embase, CINAHL, PEDro, Index to Chiropractic Literature, and two trials registers to 7 January 2020. We checked the reference lists of eligible studies and relevant systematic reviews and performed forward citation searching.
SELECTION CRITERIA:
We included randomised controlled trials (RCTs) on therapeutic ultrasound for chronic non-specific LBP. We compared ultrasound (either alone or in combination with another treatment) with placebo or other interventions for chronic LBP.
DATA COLLECTION AND ANALYSIS:
Two review authors independently assessed the risk of bias of each trial and extracted the data. We performed a meta-analysis when sufficient clinical and statistical homogeneity existed. We determined the certainty of the evidence for each comparison using the GRADE approach.
MAIN RESULTS:
We included 10 RCTs involving a total of 1025 participants with chronic LBP. The included studies were carried out in secondary care settings in Turkey, Iran, Saudi Arabia, Croatia, the UK, and the USA, and most applied therapeutic ultrasound in addition to another treatment, for six to 18 treatment sessions. The risk of bias was unclear in most studies. Eight studies (80%) had unclear or high risk of selection bias; no studies blinded care providers to the intervention; and only five studies (50%) blinded participants. There was a risk of selective reporting in eight studies (80%), and no studies adequately assessed compliance with the intervention. There was very low-certainty evidence (downgraded for imprecision, inconsistency, and limitations in design) of little to no difference between therapeutic ultrasound and placebo for short-term pain improvement (mean difference (MD) -7.12, 95% confidence interval (CI) -17.99 to 3.75; n = 121, 3 RCTs; 0-to-100-point visual analogue scale (VAS)). There was also moderate-certainty evidence (downgraded for imprecision) of little to no difference in the number of participants achieving a 30% reduction in pain in the short term (risk ratio 1.08, 95% CI 0.81 to 1.44; n = 225, 1 RCT). There was low-certainty evidence (downgraded for imprecision and limitations in design) that therapeutic ultrasound has a small effect on back-specific function compared with placebo in the short term (standardised mean difference -0.29, 95% CI -0.51 to -0.07 (MD -1.07, 95% CI -1.89 to -0.26; Roland Morris Disability Questionnaire); n = 325; 4 RCTs), but this effect does not appear to be clinically important. There was moderate-certainty evidence (downgraded for imprecision) of little to no difference between therapeutic ultrasound and placebo on well-being (MD -2.71, 95% CI -9.85 to 4.44; n = 267, 2 RCTs; general health subscale of the 36-item Short Form Health Survey (SF-36)). Two studies (n = 486) reported on overall improvement and satisfaction between groups, and both reported little to no difference between groups (low-certainty evidence, downgraded for serious imprecision). One study (n = 225) reported on adverse events and did not identify any adverse events related to the intervention (low-certainty evidence, downgraded for serious imprecision). No study reported on disability for this comparison. We do not know whether therapeutic ultrasound in addition to exercise results in better outcomes than exercise alone because the certainty of the evidence for all outcomes was very low (downgraded for imprecision and serious limitations in design). The estimate effect for pain was in favour of the ultrasound plus exercise group (MD -21.1, 95% CI -27.6 to -14.5; n = 70, 2 RCTs; 0-to-100-point VAS) at short term. Regarding back-specific function (MD - 0.41, 95% CI -3.14 to 2.32; n = 79, 2 RCTs; Oswestry Disability Questionnaire) and well-being (MD -2.50, 95% CI -9.53 to 4.53; n = 79, 2 RCTs; general health subscale of the SF-36), there was little to no difference between groups at short term. No studies reported on the number of participants achieving a 30% reduction in pain, patient satisfaction, disability, or adverse events for this comparison.
AUTHORS' CONCLUSIONS:
The evidence from this systematic review is uncertain regarding the effect of therapeutic ultrasound on pain in individuals with chronic non-specific LBP. Whilst there is some evidence that therapeutic ultrasound may have a small effect on improving low back function in the short term compared to placebo, the certainty of evidence is very low. The true effect is likely to be substantially different. There are few high-quality randomised trials, and the available trials were very small. The current evidence does not support the use of therapeutic ultrasound in the management of chronic LBP.
