Background
It is common for people to feel pain in their lower back. When the cause of pain is unknown, we say that the pain is ‘non-specific’. Pain that lasts for more than three months is considered to be 'chronic'.
Chronic non-specific low back pain can be disabling. It can cause people to miss work. Often, people with chronic non-specific back pain seek medical care.
Ultrasound therapy is the use of sound waves (vibrations) to treat medical problems. It is commonly used to treat low back pain. A healthcare provider rubs a hand-held machine against the skin on the lower back. The machine produces vibrations that go through the skin. The aim is to deliver heat and energy to body parts under the skin, to reduce pain and speed up recovery.
This Cochrane Review aimed to find out whether ultrasound is effective for treating chronic non-specific low back pain, and whether it causes any unwanted effects. Specifically, we wanted to know if ultrasound affected the following outcomes: pain, people feeling restricted in their daily life by pain, satisfaction with the treatment, well-being, disability, and other unwanted effects.
What did we look for?
We looked for studies published up to January 2020 that:
• were randomised controlled trials, medical studies where people are randomly put into one of two or more treatment groups. This type of study provides the most reliable evidence about whether a treatment makes a difference;
• included people with chronic non-specific low back pain who were aged 18 years or older;
• compared ultrasound (either alone or with another treatment) with a placebo (fake treatment) or other treatments for chronic non-specific low back pain.
What did we find?
We found 10 studies that included a total of 1025 people treated for chronic non-specific low back pain.
Most people in the studies had mild to moderate back pain, which means they may have found daily activities painful. They were treated in outpatient hospital departments or clinics, where they typically had six to 18 sessions of ultrasound therapy. Study participants were then followed for a period of time after the treatment (usually a few days or weeks).
Studies compared ultrasound to one or more of the following: placebo (five studies), no treatment (one study), electrical pulses (one study), manipulation of the spine (one study), osteopathy (one study), and laser therapy (one study). Three studies compared ultrasound with exercise to exercise alone. None of the studies was commercially funded.
Key results
There is little to suggest that ultrasound is an effective treatment for people with non-specific chronic low back pain.
Ultrasound compared with placebo
We do not know whether ultrasound reduces average pain intensity because this has been studied in too few people, in studies that gave varying answers and were poorly conducted. Ultrasound probably makes little or no difference to the number of people in whom pain is reduced by 30% or more in the short term (i.e. less than three months after the start of the study).
Ultrasound probably makes little or no difference to people’s well-being. It may make little or no difference to how much people feel restricted by their back pain in daily life, or to how satisfied people are with their treatment.
Ultrasound may have little or no impact on unwanted effects. We do not know whether ultrasound affects disability since no studies investigated this.
Ultrasound with exercise compared with exercise alone
We do not know whether ultrasound affects the outcomes of interest in this review because either no studies investigated them, or because the studies that did were imprecise or poorly conducted.
Certainty of the evidence
Based on the studies we found, there was mostly low- to very low-certainty evidence that ultrasound makes little or no difference to pain and well-being compared to placebo. For all the other outcomes and comparisons, we are less confident in the results we reported. This is because studies were too imprecise or were poorly conducted.
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.
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.
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.
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.
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.
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.
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.