Pragmatic Evidence Based Review The efficacy of acupuncture in the management of musculoskeletal pain Reviewer Natalie Hardaker and Mark Ayson Date Report Completed August 2011 Important Note: • This report is not intended to replace clinical judgement, or be used as a clinical protocol. • A robust evidence-based review of clinical guidelines, systematic reviews and high quality primary evidence relevant to the focus of this report was carried out. This does not however claim to be exhaustive. • The document has been prepared by the staff of the research team, ACC. The content does not necessarily represent the official view of ACC or represent ACC policy. • This report is based upon information supplied up to 31st July 2011 Purpose The purpose of the report is to; • Briefly describe traditional Chinese medicine (TCM) acupuncture and western medical acupuncture • Report the efficacy of acupuncture for the treatment of injury-related spine, shoulder, knee & ankle conditions • Report the comparative efficacy of acupuncture when considering alternative conservative treatment interventions for the spine, shoulder, knee & ankle • Report any adverse reactions cited in the literature. Scope This report will be restricted to acupuncture involving various modes of needling (including electroacupuncture) for musculoskeletal pain from knee, spine, shoulder and ankle injuries. Treatment modalities of TCM like cupping, scraping, Chinese massage, and herbalism will not be addressed. A c c ide nt Co m p ens a t io n Co rp o rat io n Page 1 No distinction will be made between traditional Chinese medical acupuncture and western medical acupuncture Summary Message The evidence for the effectiveness of acupuncture is most convincing for the treatment of chronic neck and shoulder pain. In terms of other injuries, the evidence is either inconclusive or insufficient. The state of the evidence on the effectiveness of acupuncture is not dissimilar to other physical therapies such as physiotherapy, chiropractic and osteopathy. Key findings General • There is insufficient evidence to make a recommendation for the use of acupuncture in the management of acute neck, back or shoulder pain • There is emerging evidence that acupuncture may enhance/facilitate other conventional therapies (including physiotherapy & exercise-based therapies) • There is a paucity of research for the optimal dosage of acupuncture treatment for treating shoulder, knee, neck and lower back pain • Studies comparing effective conservative treatments (including simple analgesics, physical therapy, exercise, heat & cold therapy) for (sub) acute and chronic non- specific low back pain (LBP) have been largely inconclusive Lower back • The evidence for the use of acupuncture in (sub)acute LBP is inconclusive • There is limited evidence to support the use of acupuncture for pain relief in chronic LBP in the short term (up to 3 months) • The evidence is inconclusive for the use of acupuncture for long term (beyond 3 months) pain relief in chronic LBP • There is no evidence to recommend the use of acupuncture for lumbar disc herniation related radiculopathy (LDHR) Neck • There is good evidence that acupuncture is effective for short term pain relief in the treatment of chronic neck pain • There is moderate evidence that real acupuncture is more effective than sham acupuncture for the treatment of chronic neck pain • There is limited evidence that acupuncture has a long term effect on chronic neck pain Shoulder • There is good evidence from one pragmatic trial that acupuncture improves pain and mobility in chronic shoulder pain • There is limited evidence for the efficacy of acupuncture for frozen shoulder • There is contradictory evidence for the efficacy of acupuncture for subacromial impingement syndrome A c c ide nt Co m p ens a t io n Co rp o rat io n Page 2 Knee • There is no evidence to recommend the use of acupuncture for injury-related knee pain Ankle • There is no evidence to recommend the use of acupuncture for ankle pain A c c ide nt Co m p ens a t io n Co rp o rat io n Page 3 Background Acupuncture has roots in ancient Chinese philosophy. Traditional Chinese Medicine (TCM) acupuncture is based on a number of philosophical concepts, one of which is that any manifestation of pain/dysfunction is a sign of imbalance of energy flow within the body. It is in this context that the TCM acupuncturist uses a holistic treatment approach. TCM acupuncture involves inserting needles into traditional meridian points with the intention on influencing energy flow within that meridian1. Acupuncture has been adopted into western medicine and treatments; many physicians currently practicing acupuncture reject such pre- scientific notions described above, using unnamed tender or trigger points to stimulate nerves or muscles1. Further to this acupuncture is also now regularly practiced globally by a specialist sub-group of physiotherapists and some other health professionals. New Zealand physiotherapists have been practicing acupuncture since 19722. As a technique acupuncture includes the invasive or non-invasive stimulation of specific anatomical locations by means of needles or other thermal, electrical, light, mechanical or manual methods3. Acupuncture is most commonly used to treat chronic pain4 5 and is currently used for a variety of conditions, including; spinal cord injury6, visceral dysfunction The other two studies compared 'traditional acupuncture' with suprascapular nerve block and acupuncture 'according to Jing Luo' respectively*6, headaches4, addictions6 emesis developing after surgery or chemotherapy in adults The other two studies compared 'traditional acupuncture' with suprascapular nerve block and acupuncture 'according to Jing Luo' respectively†, nausea associated with pregnancy6 and dental pain7; all of which fall outside the scope of this report. Acupuncture is also used to treat a number of musculoskeletal conditions, including shoulder6, wrist, and lower back pain4 6 7 The other two studies compared 'traditional acupuncture' with suprascapular nerve block and acupuncture 'according to Jing Luo' respectively‡, knee pain4 6, neck pain, tennis/golfers elbow and ankle pain6. Modern acupuncture includes manual stimulation of needles that are inserted into the skin. Various adjuncts are often used including: electrical acupuncture (electrical stimulator connected to acupuncture needle), injection acupuncture (herbal extracts injected into acupuncture points), heat lamps, and moxibustion with acupuncture (the moxa herb, Artemesia vulgaris, is burned at the end of a needle). Dry needling is a technique used to treat myofascial pain in any part of the body8, by definition trigger point dry needling (TDN) and Intramuscular manual therapy (IMT) are acupuncture techniques3. Dry needling involves the insertion of a needle at specific trigger points, the needle being a solid acupuncture needle or a dry injection needle. 1. Methodology Comprehensive literature searching was carried out focused on the efficacy of acupuncture for spine, knee, shoulder and ankle pain. The databases accessed for the search were, Medline®, CINAHL, EMBASE, AMED, PsychINFO, PubMed and Medline-in-process and Google. These databases will capture most, if not all, of the more robust clinical studies that may have been reported in the TCM-specific databases. In addition, the databases used here are used routinely in evidence-based research for complementary and alternative medicines. Of note, the TCM-specific databases contain many case series studies and other study designs that would be excluded from this report. * see Green 200537. Green S, et al. Acupuncture for shoulder pain. Cochrane Database Syst Rev 2005(2):CD005319. for more details † see Green 200537. Green S, et al. Acupuncture for shoulder pain. Cochrane Database Syst Rev 2005(2):CD005319. for more details ‡ see Green 200537. Green S, et al. Acupuncture for shoulder pain. Cochrane Database Syst Rev 2005(2):CD005319. for more details A c c ide nt Co m p ens a t io n Co rp o rat io n Page 4 The search was run on the 31st July 2011 for the period 2000 to present. Manual searching of reference lists was also carried out. A pragmatic approach was taken initially searching for randomised controlled trials (RCTs), systematic reviews and meta-analyses, as the highest levels of evidence. RCT’s are also the trial design of choice when investigating treatment efficacy. The literature was critically appraised using SIGN9 (see below) grading system for systematic reviews and RCTs. SIGN – LEVELS OF EVIDENCE 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias 2++ High quality systematic reviews of case control or cohort or studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g. case reports, case series 4 Expert opinion 3. Review of the Literature Neck pain and lower back pain (LBP) are two conditions that can be problematic to treat. Studies examining effective conservative treatments for (sub)acute and chronic non-specific low back pain have been largely inconclusive. This is also true of neck and thoracic spine pain. A lot of the literature focuses on chronic spinal pain; there are no high quality trials for the treatment of acute spinal pain. There is limited evidence to suggest that acupuncture is not an appropriate treatment for any spinal condition with suspected neurological involvement10 11. 3.1 Lower Back Pain Chronic spinal pain presents a diagnostic and treatment challenge ,reaching a specific diagnosis is often difficult. Effective conservative treatments for (sub)acute and chronic non- specific LBP have been largely inconclusive12. Differing patient populations and methodologies make direct comparison of studies problematic often resulting in inconclusive findings. Studies comparing spinal manipulation, medication, and acupuncture for chronic spinal pain revealed that spinal manipulation produced the greatest benefit both in the short13 and long term 12; within these studies acupuncture produced ‘consistent’ improvement in outcomes although this did not reach statistical significance. Outcome measures addressed both pain and function (Oswestrey scale, Visual Analogue Scale (VAS), lumbar flexion in sitting and standing); overall recovery was 27% of the patients receiving spinal manipulation, 9.4% of those receiving acupuncture and only 5% of those receiving medication. It is noteworthy A c c ide nt Co m p ens a t io n Co rp o rat io n Page 5 here that spinal manipulation is not appropriate for all LBP patients and a range of conservative treatment options must always be considered. In this study it was not possible to blind the patient and the therapist to the treatment allocation due to the ‘hands on’ nature of manipulation and acupuncture, therefore the placebo effect cannot be discounted. In a study14 comparing 3 different acupuncture approaches (individualised, standardised & sham) to standard care (inclusive of medications, primary care and physical therapy, non- study related), all groups treated with acupuncture demonstrated greater improvement in dysfunction than standard care14. The acupuncture groups included in this study all used different needle locations and depths, which suggests that this is unimportant in eliciting a therapeutic effect and may in-fact represent a placebo or non-specific effect. This was the only study reporting on function; the literature more frequently reports pain relieving effects. Itoh et al15 reported that a study group receiving trigger point acupuncture recorded significantly less pain (VAS) than a sham control group. This finding remained true when the groups were crossed over following a 3 week washout period. As acknowledged by the authors, the 3 week washout may have been insufficient and therefore a carry over treatment effect could not be discounted. This study does however support the notion that both sham and real acupuncture exert positive therapeutic effects on chronic LBP and that real acupuncture is more effective than sham. A systematic review of acupuncture for chronic LBP16 returned only 5 RCT’s. A meta- analysis was not performed due to the wide disparities in design, groups, needling points, control groups and how & when pain relief outcomes were measured in these studies. The trials were examined individually, and did not provide definitive evidence to support or refute acupuncture as an effective treatment for chronic LBP. Closer examination of the articles included in the review reveals that the results of the RCT’s show a trend towards study groups receiving some form of acupuncture intervention show improvement/positive treatment effects. However in agreement with the review author there are some methodological issues within the studies that prevent the drawing of definitive conclusions. A systematic review8 concluded that in chronic LBP acupuncture is more effective than no treatment or sham treatment at up to 3 month follow up. It was also reported that acupuncture as an adjunct to conventional therapies is more effective than conventional therapies alone. Dry needling is also considered in this review and reported as a useful adjunct to other therapies for chronic LBP. A larger systematic review 1 inclusive of both acute and chronic LBP focused on the primary outcome of short term pain relief reports that acupuncture is described as statistically significantly and clinically important and is more effective than sham acupuncture and concludes that acupuncture effectively relieves chronic LBP. It is noteworthy that of the 33 RCTs included in the review only 22 could be included in the meta-analysis due to the heterogeneity across the study samples and methodologies in the remaining 11 RCTs, 4 of which were related to chronic LBP. The quality of the studies included in the meta-analysis is variable, as such the findings from this review should only be considered as somewhat preliminary. Future publication of larger trials would have an impact on the evidence overall. A more recent systematic review17 inclusive of 6 RCTs not published when previous reviews1 8 were carried out reported that there is moderate evidence that acupuncture is more effective than no treatment and strong evidence of no significant difference between acupuncture and sham acupuncture for short term pain relief for chronic LBP. Considering 3 systematic reviews1 8 17 of reasonable quality the evidence shows a trend towards acupuncture being more effective than no treatment, however the evidence remains limited. There are inconsistent findings for acupuncture versus sham acupuncture. There is consistent evidence that acupuncture is a useful adjunct to other conservative treatments A c c ide nt Co m p ens a t io n Co rp o rat io n Page 6 (physiotherapy, exercise based therapy, education, osteopathy). It remains unclear whether acupuncture is more effective than other aforementioned conservative treatments and this requires further investigation. Six12-14 18-22 RCT’s of reasonable quality consistently reported that acupuncture has ‘minimal’ or ‘some’ positive effect on chronic LBP. Due to the differences in study population and methodologies it is difficult to compare these studies, therefore the evidence to support acupuncture for chronic LBP is limited. There were only 2 studies which included (sub)acute LBP; 1 RCT22 and 1 systematic review8. The RCT included a sham group and an acupuncture treatment group, the treatment group reported statistically significant improvement in pain at 3 months post treatment and reported taking less pain control medication. However this study is underpowered and alone offers little towards a definitive conclusion around the efficacy of acupuncture for (sub)acute LBP. The systematic review8 reports that there is insufficient evidence to support the efficacy of acupuncture or dry needling in acute LBP. Based on this evidence it is not possible to draw definitive conclusions about the effect of acupuncture for treating (sub)acute LBP. When considering back pain associated with lumbar disc herniation radiculopathy (LDHR) there is no evidence for the use of acupuncture10. As such acupuncture is not recommended as a treatment for this pathology. Lower back Author/Study Level of evidence Findings/Adverse effects 1a. Lynton et al (2003) 1+ Acupuncture minimally Chronic Spinal Pain: A effective Randomized Clinical Trial Manipulation gives greater Comparing Medication, pain relief in short term Acupuncture and Spinal Manipulation Adverse effects – none reported for acupuncture 1b. Muller et al (2005) Long- 1+ Acupuncture minimally term follow-up of a effective randomized clinical trial Manipulation gives greater assessing the efficacy of pain relief in long term medication, acupuncture, and spinal manipulation for Adverse effects - none chronic mechanical spinal reported pain syndromes 2a. Cherkin et al (2008) 1- Acupuncture produced short & Efficacy of acupuncture for long term improvement in chronic low back pain: function but not symptoms protocol for a randomized Acupuncture more effective controlled trial than ‘usual care’ 2b. Cherkin et al (2009) A Site & depth of penetration Randomised Trial Comparing appear unimportant in eliciting Acupuncture and Usual Care therapeutic benefit. A c c ide nt Co m p ens a t io n Co rp o rat io n Page 7 Lower back for Chronic Low Back Pain May represent placebo or non-specific effects Adverse effects – none reported 3. Itoh et al (2006) Effects of 1+ Trigger point acupuncture trigger point acupuncture on effective for short term relief of chronic low back pain in low back pain in elderly elderly patients -- a sham- patients controlled randomised trial Trigger point acupuncture more effective than sham Adverse effects – none reported 4. Itoh et al (2004) Trigger 1+ Deep needling to trigger point acupuncture treatment points more effective in the of chronic low back pain in treatment of low back pain in elderly patients -- a blinded elderly patients than standard randomized control trial acupuncture or superficial needling to trigger points Adverse effects – None reported 5. Kennedy et al (2008) 1- Acupuncture more effective Acupuncture for acute non- than sham treatment for pain specific low back pain: a pilot relief randomised non-penetrating Adverse effects – none sham controlled trial reported 6. Brinkhaus et al 2006 1+ Acupuncture is more effective Acupuncture in patients with in improving pain than chronic low back pain: a minimal§ acupuncture and no randomized controlled trial acupuncture treatment in patients with chronic low back pain Duration of treatment effects is unclear Adverse effects – none reported 7. Hahne et al (2010) 1++ Search returned no studies Conservative management of including acupuncture lumbar disc herniation with associated radiculopathy: A systematic review § minimal acupuncture is where the needle is inserted into the skin at a lesser depth than ‘normal’ acupuncture A c c ide nt Co m p ens a t io n Co rp o rat io n Page 8 Lower back 8. Henderson (2002) 1+/2++ Inconclusive Acupuncture: evidence for its Adverse effects – none use in chronic low back pain reported 9. Furlan et al (2005) 1++ Insufficient evidence to Acupuncture and Dry- support efficacy of Needling for Low Back Pain: acupuncture or dry needling in An Updated Systematic acute LBP Review Within the Framework Adverse effects – 13/245 of the Cochrane Collaboration patients (5%) experienced minor complications 10. Manheimer et al (2005) 1+ Evidence inconclusive for acute LBP Meta-Analysis: Acupuncture for Low Back Pain Acupuncture significantly more effective than sham acupuncture for short term pain relief in chronic LBP No evidence to that acupuncture is more effective than other conservative treatments No adverse effects reported 11. Yuan et al (2008) 1++ Moderate evidence that acupuncture is more effective Effectiveness of Acupuncture than no treatment for Low Back Pain. A Systematic Review Strong evidence that there is no significant difference between acupuncture and sham acupuncture for short term pain relief Strong evidence that acupuncture is a useful adjunct to other convservative treatment in the management of non-specific LBP 3.2 Neck Historically conservative interventions for neck pain include: muscle relaxants, steroid injections, manual therapy, physical therapy, behavioural therapy, traction, cervical collar, electromagnetic therapy and proprioceptive exercises23. Evaluation of RCT’s24 shows there is currently little clear evidence to demonstrate one conservative modality to be most effective. More high quality studies are needed in this area. A c c ide nt Co m p ens a t io n Co rp o rat io n Page 9 Short term reduction of pain has been considered the primary outcome of treatment23. Positive results are reported for short term pain reduction23; however the effectiveness of acupuncture for treating disability and long term pain in the neck remains unproven. A systematic review25 conducting a single meta-analysis comparing acupuncture with sham acupuncture (2 studies), active treatment (4 studies), inactive treatment (8 studies) and wait list control (1 study) concluded that there is moderate evidence to support that acupuncture is more effective in providing both immediate and short term relief from neck pain than sham acupuncture and inactive treatments. A further systematic review23 including quantitative meta-analysis of 14 RCT’s confirmed the short-term effectiveness and efficacy of acupuncture in the treatment of neck pain. The control groups included in this meta-analysis were sham acupuncture, physical therapy, massage, waiting list, anti-inflammatory medication and routine care. Eleven out of the fourteen studies highlighted that real acupuncture is significantly more effective in relieving pain than ‘control’ groups inclusive of sham, inactive treatment, massage and anti inflammatory medication. Conversely five of the fourteen studies found that there was no difference between acupuncture and control groups inclusive of sham acupuncture and physical therapy. In these studies both acupuncture and ‘control’ showed positive therapeutic effects. There is contradictory evidence when considering sham laser acupuncture; 2 high quality RCT’s delivered conflicting outcomes. Systematic reviews23 25 report inconclusive findings around the long term effects of acupuncture on neck pain. However closer examination of the evidence reveals a positive trend towards acupuncture having a long term effect11 26 27. The strongest evidence of long term effects comes from He et al26. Interestingly within this study the dosage of treatment was quite intense; 10 sessions over a period of 3-4 weeks, which may contribute to the long term effects seen in this study. There was no detail of the length of each treatment session. As previously noted, there is a lack of evidence specifically investigating optimal dosage for acupuncture treatment. This may influence the magnitude and duration of treatment effect. Where the literature does report dosage, frequency of sessions ranges from 1 to 14 sessions over a treatment period of 3-12 weeks. Neck Author/Study Level of evidence Findings/Adverse effects 1. Itoh et al (2007) 1+ Trigger Point acupuncture Randomised trial of trigger more effective for pain relief & point acupuncture compared improved Qualify Of Life with other acupuncture for compared to non-trigger point treatment of chronic neck pain or sham acupuncture Trigger point acupuncture may be more effective on chronic neck pain in aged patients than standard acupuncture therapy Adverse effects – none reported 2. White et al (2004) 1- Acupuncture was more Acupuncture versus placebo effective than mock treatment for the treatment of chronic for pain relief at short term mechanical neck pain: a follow up A c c ide nt Co m p ens a t io n Co rp o rat io n Page 10