Evidence-based practice: external clinical evidence can inform, but can never replace, individual clinical expertise

 In Dry Needling
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Rather than publish their findings or conclusions in a peer-reviewed journal, Ridgeway and Venere continue to use blog sites and social media in an attempt to convince physical therapists that dry needling is not an effective treatment option for any condition; that is, they claim dry needling does not provide clinically meaningful reductions in pain and disability for any musculoskeletal disorder.1 More specifically, Venere and Ridgeway assert that the use of acupuncture as an adjunct to conservative physical therapy treatment is not supported by the literature.

We do acknowledge that Drs. Dunning, Butts, Perreault and Mourad teach classes in dry needling to physical therapists, medical physicians and acupuncturists throughout the United States and worldwide through Dry Needling Institute;2 however, we do not teach or practice traditional Chinese acupuncture. To be clear on nomenclature, local injection therapies, often referred to as “wet needling”, use hollow-bore needles to deliver corticosteroids, anaesthetics, sclerosants, botulinum toxins, or other agents.3,4 In contrast, “dry needling” refers to the insertion of thin monofilament needles, as used in the practice of acupuncture, without the use of injectate.5-8 Dry-needling is typically used to treat muscles, ligaments, tendons, subcutaneous fascia, scar tissue, peripheral nerves, and neurovascular bundles for the management of a variety of neuromusculoskeletal pain syndromes.5,8,9 Interestingly, the most common term used to describe dry needling is “acupuncture”—i.e. “acu” literally translates to needle and “puncture” to penetration. Physiotherapists and/or medical physicians114-116,119,160,171-174 within both government administered national health services and mainstream university health systems10-18 in the UK,19-26 Canada,14 USA and Germany10-13,15-18 use the term ”acupuncture” to describe dry needling methodologies. The same is true in articles published in mainstream, highly respected journals, including the British Medical Journal,19,22,26-29 European Journal of Pain,20,30 Archives of Physical Medicine & Rehabilitation,31-36 Pain,8,13,17,37-42 Annals of Internal Medicine,6,24,43-46 Headache,47,48 Rheumatology,23,49-51 Spine,7,14,52-57 and Cochrane Database of Systematic Reviews.58,59 It would therefore be a mistake to ignore the findings of high-quality, randomized controlled trials,12,14-16,19,22,24,29,42,43,55,60-67 systematic reviews,10,31,53,56,68-71 meta-analyses,30,51 Cochrane reviews,58,59,72 the British practice guidelines,28 the European practice guidelines,73,74 and the joint clinical practice guidelines from the American College of Physicians and the American Pain Society44 simply because they used the term “acupuncture” instead of dry needling in their title and/or methods section.

As Dunning et al75 points out, “physical therapists do not ignore or exclude studies published by MDs, DOs and DCs when citing references to support the use of spinal manipulation treatments for a wide variety of neuromusculoskeletal conditions simply because the authors consider the techniques as chiropractic or osteopathic manipulations.” Therefore, we should not ignore the findings of high-quality and well-powered acupuncture trials that have used Western medical diagnoses (e.g. knee osteoarthritis, carpal tunnel syndrome), Western science (e.g. fMRI), and Western practitioners (i.e. in the main by physiotherapists and/or medical physicians from the U.K. and Germany) in the treatment of neuromusculoskeletal conditions.

Dr. David Sacket, a man widely considered to be the father of evidence-based medicine, defined evidence-based practice as “the integration of best research with clinical expertise and patient values.”76 There are 3 pillars to evidence-based practice, not one, and each pillar has equal importance. Put more eloquently by Sacket et al,77 “External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how should it be integrated into a clinical decision.” Moreover, evidence-based medicine is not restricted to randomized controlled trials, systematic reviews and meta-analyses.77 In the seminal article “Evidence-based medicine: what it is and what it isn’t”, Sackett et al77 stated, “Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannized by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient.” Therefore, the claim that dry needling has no clinically meaningful effect on pain for any musculoskeletal condition by Venere and Ridgeway—two physical therapists that work in home health and an inpatient intensive care unit, respectively, who now, after specific questioning online, admit that they have never received any formal training in dry needling and have never used dry needling on any patient78—should be viewed very cautiously. Therefore, according to Sackett et al, it does matter, and it is relevant, that Venere and Ridgeway are making up their own “practice guidelines” for dry needling, yet to our knowledge, neither of them have any clinical experience in such (pillars two and three of EBP). Perhaps a stool with one leg is a fair comparison to the stance Venere and Ridgeway have taken. Clinical experience is paramount to evidence-based medicine and this is why all three pillars to evidence-based practice are used when developing clinical practice guidelines. In 2008, 16 experts from a variety of medical disciplines (primary care, rheumatology, orthopedics and evidence-based medicine) and from 6 countries (USA, UK, France, Netherlands, Sweden and Canada) published the OARSI (OsteoArthritis Research Society International) guidelines for hip and knee OA, recommending acupuncture with a 69% consensus.79

More importantly however, and contrary to the claims made by Venere and Ridgeway, the evidence itself (i.e. journal articles) does overwhelmingly support a clinically meaningful reduction in pain and disability when acupuncture is used as an adjunct or standalone intervention for knee osteoarthritis—the condition we originally commented on in a letter to the editor in response to the publication of the Hinman et al80 trial.

In short, there are 8 systematic reviews and/or meta-analyses,81-88 1 Cochrane review,89 and 7 randomized control trials15,29,39,90-93 that have reported positive effects for acupuncture in patients with joint osteoarthritis (OA).94 The details of these studies are summarized below along with the general conclusions of each author.

Vickers et al81 (meta-analysis; 29 RCTs; n=17,922)
“In conclusion, we found acupuncture to be superior to both no-acupuncture control and sham acupuncture for the treatment of chronic pain. Although the data indicate that acupuncture is more than a placebo, the differences between true and sham acupuncture are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to therapeutic effects.”

Ezzo et al84 (systematic review; 7 RCTs; n=393)
“For pain and function, there was limited evidence that acupuncture is more effective than being on a waiting list for treatment or having treatment as usual. For pain, there was strong evidence that real acupuncture is more effective than sham acupuncture; however, for function, there was inconclusive evidence that real acupuncture is more effective than sham acupuncture.”

White et al83 (systematic review; 5 RCTs; n=1,334)
“This review has found evidence that acupuncture that meets specified criteria for adequacy is superior to sham (or placebo) acupuncture for treating knee pain, both in the short term and the long term.”

Cao et al88 (systematic review & meta-analysis; 14 RCTs; n=3,835)
“Compared with sham acupuncture control treatment, acupuncture was significantly better at relieving pain and restoring function in the short-term period and at relieving pain and restoring function in the long-term.”

Manheimer et al87 (meta-analysis; 11 RCTs; n=2,821)
“Acupuncture produced clinically irrelevant short-term benefits in sham controlled trials, but clinically relevant benefits compared to usual care and waiting-list controls for the treatment of knee osteoarthritis.”

Corbett et al86 (meta-analysis; 25 RCTs; n=2,794)
“The evidence available for our network meta-analyses, in which physical interventions for osteoarthritis of the knee were compared with each other within a coherent framework, suggests that overall effectiveness is limited but that acupuncture can be considered as one of the more effective physical treatments for alleviating pain in the short-term.”

Mavrommatis et al39 (RCT; n=120)
“Acupuncture with Etoricoxib (a COX-2 selective inhibitor) is more effective than sham acupuncture with Etoricoxib, or Etoricoxib alone for the treatment of knee osteoarthritis.”

Berman et al91 (RCT; n=570)
“Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups.”

Berman et al92 (RCT; n=73)
“Patients randomized to acupuncture improved on both WOMAC and Lequesne indices compared to those who received standard treatment alone. Significant differences on total WOMAC scale (i.e. pain, disability, and stiffness) were seen at 4 and 8 weeks. There appears to be a slight decline in effect at 4 weeks after cessation of treatment (12 weeks after first treatment).”

Vas et al29 (RCT; n=97)
“Acupuncture as a complementary therapy to pharmacological treatment of osteoarthritis of the knee is more effective than pharmacological treatment alone, in terms of reducing pain and rigidity, and improving physical functioning and health related quality of life. According to the criterion that an improvement in quality of life requires changes in at least two of the variables measured by the PQLC, the acupuncture provided to the intervention group was more effective than the placebo treatment in improving patients’ quality of life.”

The information provided above clearly demonstrates that we did not misrepresent the data, the findings, or the conclusions of the acupuncture literature in any way (as claimed by Venere and Ridgeway). However, as is the case with many effectiveness and efficacy trials on other medical interventions, some of the studies on acupuncture for knee OA are stronger than others. Nevertheless, the preponderance of evidence overwhelmingly indicates that acupuncture results in significant and clinically meaningful reductions in pain and disability for patients suffering from knee OA.75

Yes, of the 8 reviews, Manheimer et al provide the weakest support for the use of acupuncture in patients with knee OA.87,89 Notably, the two reviews87,89 reported statistically significant and clinically meaningful improvements in pain and function compared to usual care and a wait-list control; however, these were clinically irrelevant improvements compared to sham acupuncture. The Manheimer studies highlight the verum versus sham acupuncture debate. Certainly, patient expectations and values concerning acupuncture may play a factor,95 especially if patients are able to distinguish the difference between real and sham acupuncture. However, as Dincer et al96 points out, designating sham acupuncture interventions as placebo controls is “misleading and scientifically unacceptable”. In addition, Lundeberg et al97 remind us, the danger of placebo acupuncture is to assume that it is a true, non-inert control and conclude that, in many trials, acupuncture is either no better than or modestly better than sham, thereby committing a type 2 error—i.e. accepting a false null hypothesis or falsely concluding that the treatment is useless.97 Corbett et al86 further alluded to the pitfalls of sham controlled acupuncture trials and reported that the effects of acupuncture in their study may have been underestimated due to the inclusion of 2 large sham controlled studies that used a placebo that likely was physiologically active.86 It appears Venere and Ridgeway have also fallen into this trap.

Notably, in a large randomized controlled trial funded by German public health insurance companies in patients (n=1162) with chronic lower back pain (LBP), acupuncture was found to demonstrate superiority over guideline-based pharmacological and non-pharmacological therapy that included physiotherapy and exercise.98 Yet, the study reported no difference between the groups receiving verum acupuncture and penetrating sham acupuncture! That is, both groups experienced significant reductions in LBP for at least 6 months, and the authors reported that the effects of acupuncture were not just due to a placebo effect. Interestingly, because of acupuncture’s superiority over multimodal conventional therapy, the German Federal Joint Committee of Physicians and Health Insurance Plans decided to offer acupuncture for chronic LBP as an insured benefit for German citizens.

One of the strongest systematic reviews on acupuncture for knee OA came from White et al.83 Interestingly, White et al combined the results of 5 RCTs and found that acupuncture for knee OA resulted in significant reductions in pain and disability (WOMAC subscale) compared to sham acupuncture and no treatment at both short-term (12 weeks) and at long-term follow-up (26-52 weeks).83 Importantly, White et al83 only included studies with a “true sham”, defined as a treatment that avoided stimulating neural structures in the same neurological segments of the knee joint. As White stated, “even superficial penetration with needles is regarded as unacceptable because it has the potential to be physiologically active.” In addition, White et al83 only included studies that adequately treated knee OA with a sufficient dosage of acupuncture. White et al defined “adequate” dosage of acupuncture for knee OA as at least 6 treatments (1 treatment per week) that incorporated 4 points in the region of the knee for at least 20 minutes with either manual stimulation (de qi) or electric stimulation.   Given that these parameters of “adequate” acupuncture are also supported by a number of other investigators,99,100 it begs the question of whether previously published RCTs on acupuncture for knee OA have incorporated suboptimal needling protocols, thereby “watering down” the results reported in some of the systematic reviews and meta-analyses. For example, although Hinman et al80 concluded that “needle and laser acupuncture were no more efficacious that sham laser acupuncture” for knee pain, it should be noted that they did not standardize the number and placement of needles, did not report whether the needles were manual manipulated, and did not use electric stimulation. Furthermore, and of major importance, unlike 11 of the 13 randomized controlled trials in the Cochrane Database systematic review101 that found acupuncture effective in patients with knee osteoarthritis, Hinman et al102 did not radiographically confirm the clinical diagnosis of knee osteoarthritis.103

Yes, statistical significance is one thing and effect size is another; however, the OARSI guidelines79 for hip and knee OA reported a moderate effect size for acupuncture for pain (0.51), stiffness (0.41), and function (0.51). In addition, Zhang et al79 reported a pooled effect size for acupuncture of 0.58 compared to usual care and wait list controls from the data provided by Manheimer et al (2007).104 MacPherson further reported a 0.27 larger effect of acupuncture with electric stimulation compared to controls.100 As expected, the effect size of acupuncture versus sham acupuncture was less (0.35 to 0.40), but this effect size is still comparable to that of NSAIDs (0.32) for knee OA!83 While it is not always appropriate to compare effect sizes among various treatments,79 to our knowledge, a pooled standard effect size of 0.58 for acupuncture in patients with knee OA is higher than any other treatment traditionally provided by a physical therapist, to include strengthening exercises (0.32) and aerobic exercises (0.52).79,104

In comparison to the large body of evidence underpinning the use of acupuncture for knee OA, there continues to be limited evidence for other commonly used, but infrequently challenged, physical therapy treatments. For example, a number of studies have demonstrated that motor control exercises targeting the deep cervical neck flexors are no better than general exercise in treating acute and chronic non-specific neck pain and whiplash associated disorder.105,106,107-109 In addition, after reviewing 31 RCTs, Kay et al110 found only limited evidence for strengthening, stretching and strengthening, and eye fixation exercises for neck pain with headache.110 Moreover, there was unclear evidence for stretching and strengthening exercises compared to manual therapy, medication, home exercise and education in acute, subacute and chronic mechanical neck pain.110 In a recent Cochrane review of 27 RCTs, the effectiveness of exercise for mechanical neck disorders still remains unclear.111 Nevertheless, a recent systematic review and meta-analysis of 7 RCTs by Bertozzi et al112 found that therapeutic exercises for chronic non-specific neck pain are supported. Notably, the authors reported effect sizes of 0.53 and 0.39 for immediately post-treatment and effect sizes of .45 and .46 at intermediate follow-up, for pain and disability, respectively.

Although effect sizes are not directly comparable across populations, the effect sizes for exercise for chronic neck pain112 seem to be in line with those reported for acupuncture in patients with knee OA.79,104 Interestingly, in a recent Cochrane review that included 54 RCTs on land based exercise for knee OA, Fransen et al113 reported a moderate effect size for immediate post treatment pain (SMD of 0.49) and a small effect size for pain (SMD of 0.24) at 2-6 months, which the authors report as equivalent to a reduction of just 6 points on a 0 to 100 point scale!

In a recent literature review on core strength and stabilization exercises for LBP, Lederman et al114 concluded,

“Core stability exercises are no more effective than, and will not prevent injury more than, any other form of exercise. Core stability exercises are no better than other forms of exercise in reducing chronic lower back pain. Any therapeutic influence is related to the exercise effects rather the core strength issues.”114

In addition, a number of randomized controlled trials and a recent systematic review by Macedo et al (2009) appear to unequivocally support Lederman’s claim.115,116, 117, 118,119 Moreover, in a 2013 systematic review and meta-analysis, Smith et al120 concluded that core strength and stabilization exercises are no more effective than any other type of exercise for improving low back pain in the long term. Yet, “core stabilization”, “specific stabilization”, “abdominal hollowing”, “feed-forward activation timing exercises”, or “motor control exercises” have been widely used and advocated by many physical therapists for the treatment of back pain for more than two decades. Why do deep neck flexor exercises for neck pain121,122,107-109 or transverse abdominus (abdominal hollowing) stabilization exercises115,116, 123, 118,119 for low back pain wear the “immunity idol”? In comparison to the pooled effect size for acupuncture in patients with knee OA (0.58), it is interesting to note that an effect size of 0.33 was found by Paatelma et al124 for functional improvements following McKenzie treatments.125 In addition, when comparing McKenzie treatments with mobilization (general care) for low back pain, Dunsford et al126 reported an effect size of 0.5 and 0.39 for pain and disability, respectively. Nevertheless, Hosseinifar et al127 found core stabilization exercises more effective than McKenzie methods for improving pain, function and transverse abdominus thickness.

The total effects of most interventions consist of non-specific and specific effects. Acupuncture and dry needling work to systemically reduce pain by activating opioid-based pain reduction,128-130 mediated by endogenous cannabinoids131-133 and the sympathetic nervous system,134,135 and non-opioid pain relief via serotonin and norepinephrine from the brain stem.128,136-138 Dry needling also triggers the HPA-axis centrally139 and the CRH-POMC-corticosteroid axis locally140 to inhibit COX-2, reducing inflammatory cytokines. At a cellular level, electrical dry needling stimulates immune cells, fibroblasts and keratinocytes to release CGRP and substance-P,141 altering CGRP stimulation of TTX receptors to reverse hyperalgesia.142 It also encourages the supraoptic nucleus to release oxytocin to quiet ASIC receptors peripherally and stimulate opioid interneurons spinally.143-145 Mechanotransduction of fibroblasts and peripheral nerves via TRPV1146 and P2X/Y-mediated intercellular Ca2+ wave propagation and subsequent activation of the nucleus accumbens inhibits spinal pain transmission via glycinergic and opioidergic interneurons.147,148 The increased ATP is metabolized to adenosine, which activates P1 purinergic receptors, events considered key to dry needling analgesia and rho kinase-based tissue remodeling.149 Even trigger point dry needling has been shown to reduce the biochemicals associated with pain and inflammation.150-152 Specific to treatment for pain due to knee osteoarthritis, Ahsin et al37 found significant increases in plasma β endorphin levels after electroacupuncture to local points at the knee that correlated with reductions in pain, stiffness and disability, which is likely due to vasodilation.

Finally, in order to address Venere and Ridgeway’s false claims that we misrepresented data in the Dunning et al75 literature review, we have included a direct link in the reference list below to the full text PDF of our original 2013 “in press” article153 and also, for comparison, the 2014 final version75 that was published by the journal Physical Therapy Reviews. In short, John Ware wrote a letter of complaint to the journal as he took issue with our use of one of eleven references, in a single sentence on page 6, which was used to support the use of acupuncture in the knee OA section. More specifically, Mr. Ware claimed that the following statement was not supported by the existing literature,

“There is overwhelming evidence from randomized controlled trials, systematic reviews, and metaanalyses that dry needling the knee joint without targeting specific TrPs is effective at reducing pain and disability in patients with chronic knee osteoarthritis.”153(p.6)

In that same letter, Mr. Ware asked the journal to retract our literature review. Therefore, rather than publish Ware’s letter-to-the-editor and give us a chance to respond in a public forum with a rebuttal, the editor in chief of Physical Therapy Reviews chose to temporarily remove our “in press” literature review from the journal website while two independent content experts reviewed the accuracy of our manuscript and Mr. Ware’s claim. After this second round of peer-review, the editor in chief of Physical Therapy Reviews found Mr. Ware’s claims of misrepresenting the literature to be unsubstantiated; furthermore, the two content experts provided us with 3 additional recent references that further supported our original statement regarding the effectiveness of acupuncture for knee osteoarthritis. This is why the 2014 published version75 has 199 references compared with 196 references in the 2013 “in press” version.153 Furthermore, the statement that Ware claimed to be inaccurate remained in the final 2014 version75 that was published in volume 19 and issue 4 of the journal Physical Therapy Reviews, and it has even added the word “strong”…

“Recent systematic reviews and meta-analyses provide strong and overwhelming evidence for the effectiveness of acupuncture in the treatment of knee osteoarthritis.”75(p.257)

Again, both versions are fully accessible in an open-access and full text PDF format for anyone’s review. While we appreciate the debate on the use of acupuncture for knee OA, Venere and Ridgeway should take caution before publicly questioning our integrity without having their facts straight.

Nevertheless, the bottom line for our response to Venere and Ridgeway is as follows:

1. There are 3 pillars to evidence-based practice, not one, and each pillar has equal importance. As stated by Sacket et al,77 “External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how should it be integrated into a clinical decision.” Moreover, Sackett,77 the father of evidence-based medicine, stated, “Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannized by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient.”

2. “Recent systematic reviews and meta-analyses provide strong and overwhelming evidence for the effectiveness of acupuncture in the treatment of knee osteoarthritis.”75(p.257)

AUTHORS

James Dunning, DPT, MSc (Manip Ther), MAACP (UK), FAAOMPT
Director, AAMT Fellowship in Orthopaedic Manual Physical Therapy
President, Alabama Physical Therapy & Acupuncture, Montgomery, AL

Raymond Butts, PhD, DPT, MSc (NeuroSci), Cert. DN, Cert. SMT
Senior Instructor, Spinal Manipulation Institute & Dry Needling Institute
Senior Faculty, AAMT Fellowship in Orthopaedic Manual Physical Therapy

Thomas Perreault, DPT, OCS, Cert. DN, Cert. SMT
Clinic Director, Portsmouth Physical Therapy, Portsmouth, NH
Senior Faculty, AAMT Fellowship in Orthopaedic Manual Physical Therapy

Firas Mourad, PT, OMT, Cert. SMT, Dip. Osteopractic
Lecturer, Master in Sports Rehabilitation Program, University of Pisa, Italy
Senior Faculty, AAMT Fellowship in Orthopaedic Manual Physical Therapy

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