Treatments for Morton's neuroma.

BACKGROUND: Morton's neuroma (MN) is a painful neuropathy resulting from a benign enlargement of the common plantar digital nerve that occurs commonly in the third webspace and, less often, in the second webspace of the foot. Symptoms include burning or shooting pain in the webspace that extends to the toes, or the sensation of walking on a pebble. These impact on weight-bearing activities and quality of life. OBJECTIVES: To assess the benefits and harms of interventions for MN. SEARCH METHODS: On 11 July 2022, we searched CENTRAL, CINAHL Plus EBSCOhost, ClinicalTrials.gov, Cochrane Neuromuscular Specialised Register, Embase Ovid, MEDLINE Ovid, and WHO ICTRP. We checked the bibliographies of identified randomised trials and systematic reviews and contacted trial authors as needed. SELECTION CRITERIA: We included all randomised, parallel-group trials (RCTs) of any intervention compared with placebo, control, or another intervention for MN. We included trials where allocation occurred at the level of the individual or the foot (clustered data). We included trials that confirmed MN through symptoms, a clinical test, and an ultrasound scan (USS) or magnetic resonance imaging (MRI). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. We assessed bias using Cochrane's risk of bias 2 tool (RoB 2) and assessed the certainty of the evidence using the GRADE framework. MAIN RESULTS: We included six RCTs involving 373 participants with MN. We judged risk of bias as having 'some concerns' across most outcomes. No studies had a low risk of bias across all domains. Post-intervention time points reported were: three months to less than 12 months from baseline (nonsurgical outcomes), and 12 months or longer from baseline (surgical outcomes). The primary outcome was pain, and secondary outcomes were function, satisfaction or health-related quality of life (HRQoL), and adverse events (AE). Nonsurgical treatments Corticosteroid and local anaesthetic injection (CS+LA) versus local anaesthetic injection (LA) Two RCTs compared CS+LA versus LA. At three to six months: • CS+LA may result in little to no difference in pain (mean difference (MD) -6.31 mm, 95% confidence interval (CI) -14.23 to 1.61; P = 0.12, I2 = 0%; 2 studies, 157 participants; low-certainty evidence). (Assessed via a pain visual analogue scale (VAS; 0 to 100 mm); a lower score indicated less pain.) • CS+LA may result in little to no difference in function when compared with LA (standardised mean difference (SMD) -0.30, 95% CI -0.61 to 0.02; P = 0.06, I2 = 0%; 2 studies, 157 participants; low-certainty evidence). (Function was measured using: the American Orthopaedic Foot and Ankle Society Lesser Toe Metatarsophalangeal-lnterphalangeal Scale (AOFAS; 0 to 100 points) - we transformed the scale so that a lower score indicated improved function - and the Manchester Foot Pain and Disability Schedule (MFPDS; 0 to 100 points), where a lower score indicated improved function.) • CS+LA probably results in little to no difference in HRQoL when compared to LA (MD 0.07, 95% CI -0.03 to 0.17; P = 0.19; 1 study, 122 participants; moderate-certainty evidence), and CS+LA may not increase satisfaction (risk ratio (RR) 1.08, 95% CI 0.63 to 1.85; P = 0.78; 1 study, 35 participants; low-certainty evidence). (Assessed using the EuroQol five dimension instrument (EQ-5D; 0-1 point); a higher score indicated improved HRQoL.) • The evidence is very uncertain about the effects of CS+LA on AE when compared with LA (RR 9.84, 95% CI 1.28 to 75.56; P = 0.03, I2 = 0%; 2 studies, 157 participants; very low-certainty evidence). Adverse events for CS+LA included mild skin atrophy (3.9%), hypopigmentation of the skin (3.9%) and plantar fat pad atrophy (2.6%); no adverse events were observed with LA. Ultrasound-guided (UG) CS+LA versus non-ultrasound-guided (NUG) CS+LA Two RCTs compared UG CS+LA versus NUG CS+LA. At six months: • UG CS+LA probably reduces pain when compared with NUG CS+LA (MD -15.01 mm, 95% CI -27.88 to -2.14; P = 0.02, I2 = 0%; 2 studies, 116 feet; moderate-certainty evidence). (Assessed with a pain VAS.) • UG CS+LA probably increases function when compared with NUG CS+LA (SMD -0.47, 95% CI -0.84 to -0.10; P = 0.01, I2 = 0%; 2 studies, 116 feet; moderate-certainty evidence). We do not know of any established minimum clinical important difference (MCID) for the scales that assessed function, specifically, the MFPDS and the Manchester-Oxford Foot Questionnaire (MOXFQ; 0 to 100 points; a lower score indicated improved function.) • UG CS+LA may increase satisfaction compared with NUG CS+LA (risk ratio (RR) 1.71, 95% CI 1.19 to 2.44; P = 0.003, I2 = 15%; 2 studies, 114 feet; low-certainty evidence). • HRQoL was not measured. • UG CS+LA may result in little to no difference in AE when compared with NUG CS+LA (RR 0.42, 95% CI 0.12 to 1.39; P = 0.15, I2 = 0%; 2 studies, 116 feet; low-certainty evidence). AE included depigmentation or fat atrophy for UG CS+LA (4.9%) and NUG CS+LA (12.7%). Surgical treatments Plantar incision neurectomy (PN) versus dorsal incision neurectomy (DN) One study compared PN versus DN. At 34 months (mean; range 28 to 42 months), PN may result in little to no difference for satisfaction (RR 1.06, 95% CI 0.87 to 1.28; P = 0.58; 1 study, 73 participants; low-certainty evidence), or for AE (RR 0.95, 95% CI 0.32 to 2.85; P = 0.93; 1 study, 75 participants; low-certainty evidence) compared with DN. AE for PN included hypertrophic scaring (11.4%), foreign body reaction (2.9%); AE for DN included missed nerve (2.5%), artery resected (2.5%), wound infection (2.5%), postoperative dehiscence (2.5%), deep vein thrombosis (2.5%) and reoperation with plantar incision due to intolerable pain (5%). The data reported for pain and function were not suitable for analysis. HRQoL was not measured. AUTHORS' CONCLUSIONS: Although there are many interventions for MN, few have been assessed in RCTs. There is low-certainty evidence that CS+LA may result in little to no difference in pain or function, and moderate-certainty evidence that UG CS+LA probably reduces pain and increases function for people with MN. Future trials should improve methodology to increase certainty of the evidence, and use optimal sample sizes to decrease imprecision.

Consent in forefoot surgery; What does it mean to the patient?

AIMS: This study aimed to assess patient risk recall and find risk thresholds for patients undergoing elective forefoot procedures. METHODS: Patients were interviewed in the pre-assessment clinic (PAC) or on day of surgery (DOS); some in both settings. A standardised questionnaire was used for all interviews, regardless of setting. Patients were tested on which risks they recalled from their consent process, asked for thresholds for five pre-chosen risks and asked about a sham risk. RESULTS: Across all interviews, risk recall on DOS (2.34 risks/patient interview) was significantly lower (p=.05) than in PAC (2.95 risks/patient interview) - this was repeated when comparing results from patients interviewed in both settings only with PAC mean recall of 2.93 risks/patient interview and DOS mean recall of 2.57 risks/patient interview. The mean reported risk thresholds greatly exceeded NHS Lothian's observed complication rates for forefoot procedures. The five risks tested for thresholds produced the same order in each interview setting, suggesting a patient-perceived severity ranking. Patients answering the sham risk question incorrectly tended to recall fewer risks across all interviews. CONCLUSIONS: This study shows that patient risk recall is poor, as previous literature outlines, reinforcing that consent process improvements could be made. It also illustrates the value of PAC visits in patient education, as shown by higher levels of recall when compared to DOS.

Vulnerability in human research.

The conduct of prior ethics review of human research projects helps to protect vulnerable groups or populations from potential negative impacts of research. Contemporary considerations in human research considers the concept of vulnerability in terms of access to research opportunities, impacts on the consenting process, selection bias, and the generalisability of results. Recent work questions the validity of using enumerated lists as a check box approach to protect research participants from exploitation. Through the use of broad categories to treat cohorts of human research participants as homogenous classes and label some participants as vulnerable merely because they are members of a particular class, some ethics reviewers have used the National Statement on Ethical Conduct in Human Research to strip individuals of their "ethical equality". Labelling people as vulnerable does not help researchers or human research ethics committee members develop an understanding of the complexities of applying the principles of respect and of justice in ethical decision-making. Conversely, defining specific cohorts of research participants as needing nuanced ethical consideration, due to their vulnerable nature, may imply that other population groups need not be considered vulnerable. We contend that this assumption is erroneous. This paper explores the way that human research ethics guidance documents treat vulnerability within the Australian context and draws on contemporary discussion to focus an alternative perspective based on the principles in the National Statement on Ethical Conduct in Human Research for researchers and human research ethics committee members to consider.

Long-Term Follow-up of Arthrodesis vs Total Joint Arthroplasty for Hallux Rigidus.

BACKGROUND: The optimal operative management of hallux rigidus is still a matter for debate among surgeons. Despite arthrodesis widely considered to be the gold standard treatment, many surgeons advocate arthroplasty as a suitable alternative. There are, however, few long-term or high-quality studies evaluating these modalities. We present the 15-year follow-up of a randomized controlled trial. METHODS: This data is the follow-up to the original study published in 2005. In the original study, 63 patients (77 toes) were recruited to and randomized to have either metatarsophalangeal joint (MTPJ) arthrodesis or arthroplasty. The primary outcome measure was a decrease in pain on a visual analog scale (VAS) at 24 months. In the present study, data were available for all surviving patients (52 patients, 66 toes). Data were collected in the form of satisfaction scores, VAS for pain, the VAS foot and ankle and survivorship data. RESULTS: The results of the original study demonstrated that pain relief was greater following arthrodesis at 2 years. At 15 years, patients with an arthrodesis experienced less pain and were more satisfied compared to those with an arthroplasty. No functional differences were seen between these 2 groups. There were more revisions in the arthroplasty group. CONCLUSION: Despite the hope of better function, less pain, and greater satisfaction from MTPJ replacement, this was not found in our patient population. The long-term results of our study showed that arthrodesis outperformed arthroplasty. If an arthroplasty failed, then salvage was likely to be technically difficult, with significant potential for complications. LEVEL OF EVIDENCE: Level I, randomized controlled trial.

Beneficence as a principle in human research.

Beneficence is one of the four principles that form the basis of the Australian National Statement. The aim of this paper is to explore the philosophical development of this principle and to clarify the role that beneficence plays in contemporary discussions about human research ethics. By examining the way that guidance documents, particularly the National Statement, treats beneficence we offer guidance to researchers and human research ethics committee members on the practical application of what can be a conceptually difficult principle.

Cost-effectiveness of steroid (methylprednisolone) injections versus anaesthetic alone for the treatment of Morton's neuroma: economic evaluation alongside a randomised controlled trial (MortISE trial).

BACKGROUND: Morton's neuroma is a common foot condition affecting health-related quality of life. Though its management frequently includes steroid injections, evidence of cost-effectiveness is sparse. So, we aimed to evaluate whether steroid injection is cost-effective in treating Morton's neuroma compared with anaesthetic injection alone. METHODS: We undertook incremental cost-effectiveness and cost-utility analyses from the perspective of the National Health Service, alongside a patient-blinded pragmatic randomised trial in hospital-based orthopaedic outpatient clinics in Edinburgh, UK. Of the original randomised sample of 131 participants with Morton's neuroma (including 67 controls), economic analysis focused on 109 (including 55 controls). Both groups received injections guided by ultrasound. We estimated the incremental cost per point improvement in the area under the curve of the Foot Health Thermometer (FHT-AUC) until three months after injection. We also conducted cost-utility analyses using European Quality of life-5 Dimensions-3 Levels (EQ-5D-3L), enhanced by the Foot Health Thermometer (FHT), to estimate utility and thus quality-adjusted life years (QALYs). RESULTS: The unit cost of an ultrasound-guided steroid injection was £149. Over the three months of follow-up, the mean cost of National Health Service resources was £280 for intervention participants and £202 for control participants - a difference of £79 [bootstrapped 95% confidence interval (CI): £18 to £152]. The corresponding estimated incremental cost-effectiveness ratio was £32 per point improvement in the FHT-AUC (bootstrapped 95% CI: £7 to £100). If decision makers value improvement of one point at £100 (the upper limit of this CI), there is 97.5% probability that steroid injection is cost-effective. As EQ-5D-3L seems unresponsive to changes in foot health, we based secondary cost-utility analysis on the FHT-enhanced EQ-5D. This estimated the corresponding incremental cost-effectiveness ratio as £6,400 per QALY. Over the recommended UK threshold, ranging from £20,000 to £30,000 per QALY, there is 80%-85% probability that steroid injection is cost-effective. CONCLUSIONS: Steroid injections are effective and cost-effective in relieving foot pain measured by the FHT for three months. However, cost-utility analysis was initially inconclusive because the EQ-5D-3L is less responsive than the FHT to changes in foot health. By using the FHT to enhance the EQ-5D, we inferred that injections yield good value in cost per QALY. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13668166.

Soft tissue swellings in the foot: rheumatoid nodulosis.

Background rheumatoid nodulosis is a rare disease characterised by multiple subcutaneous nodules, a high titre of rheumatoid factor, radiologically detectable cystic bone lesions, but with none or few of the systemic manifestations or joint activity of rheumatoid disease. Histopathologically, nodulosis is the same as the nodules found in rheumatoid arthritis. It is considered to be a benign variant of rheumatoid arthritis. A 69 year old male presents with multiple subcutaneous nodules on the feet. This case study highlights the benefits of ultrasound in establishing a correct diagnosis and management. Although rare, rheumatoid nodulosis is a consideration in the differential diagnoses of soft tissue swellings in the feet.

Justice in human research ethics. A conceptual and practical guide.

One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice--hether distributive or commutative--and what counts as a just distribution or exchange--are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified. We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researches on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.

Methylprednisolone injections for the treatment of Morton neuroma: a patient-blinded randomized trial.

BACKGROUND: Morton neuroma is a common cause of neuralgia affecting the web spaces of the toes. Corticosteroid injections are commonly administered as a first-line therapy, but the evidence for their effectiveness is weak. Our primary research aim was to determine whether corticosteroid injection is an effective treatment for Morton neuroma compared with an anesthetic injection as a placebo control. METHODS: We performed a pragmatic, patient-blinded randomized trial set within hospital orthopaedic outpatient clinics in Edinburgh, United Kingdom. One hundred and thirty-one participants with Morton neuroma (mean age, fifty-three years; 111 [85%] female) were randomized to receive either corticosteroid and anesthetic (1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine) or anesthetic alone (2 mL 1% lignocaine). An ultrasonographic image was obtained before treatment, and injections were performed with the needle placed under ultrasonographic guidance. The primary outcome was the difference in patient global assessment of foot health between the two groups at three months after injection. This was measured with use of a 100-unit visual analog scale (VAS) anchored by "best imaginable health state" and "worst imaginable health state." RESULTS: Compared with the control group, global assessment of foot health in the corticosteroid group was significantly better at three months (mean difference, 14.1 scale points [95% confidence interval, 5.5 to 22.8 points]; p = 0.002). The difference between the groups was also significant at one month. Significant and nonsignificant improvements associated with the corticosteroid injection were observed for measures of pain, function, and patient global assessment of general health at one and three months after injection. The size of the neuroma as determined by ultrasonography did not significantly influence the treatment effect. CONCLUSIONS: Corticosteroid injections for Morton neuroma can be of symptomatic benefit for at least three months.

Hemiarthroplasty augmented with bone graft for the failed hallux metatarsophalangeal Silastic® implant.

Symptomatic failure of Silastic® implants at the hallux metatarsophalangeal joint can result in the challenging problem of instability which may be painful. There is often marked bone loss making reconstruction difficult. Arthrodesis sacrifices joint movement while excision arthroplasty shortens the ray and is less acceptable to active patients. We describe a case in which reconstruction was achieved by using a porous coated metatarsophalangeal hemiarthroplasty augmented with bone graft with good early results. This previously unreported technique may offer an additional surgical option for reconstruction, maintaining joint movement without compromising future arthrodesis or excision arthroplasty as salvage measures. Long term follow up is required to confirm the success of this technique.

Contextualising merit and integrity within human research.

The first consideration of any Australian Human Research Ethics Committee should be to satisfy itself that the project before them is worth undertaking. If the project does not add to the body of knowledge, if it does not improve social welfare or individual wellbeing then the use of human participants, their tissue or their data must be questioned. Sometimes, however, committees are criticised for appearing to adopt the role of scientific review committees. The intent of this paper is to provide researchers with an understanding of the ethical importance of demonstrating the merit of their research project and to help them develop protocols that show ethics committees that adequate attention has been paid to this central tenet in dealing ethically with human research participants. Any person proposing human research must be prepared to show that it is worthwhile. This paper will clarify the relationship between research merit and integrity, research ethics and the responsibilities of human research ethics committees.

WITHDRAWN. Interventions for treating plantar heel pain.

BACKGROUND: Ten percent of people may experience pain under the heel (plantar heel pain) at some time. Injections, insoles, heel pads, strapping and surgery have been common forms of treatment offered. The absolute and relative effectiveness of these interventions are poorly understood. OBJECTIVES: The objective of this review was to identify and evaluate the evidence for effectiveness of treatments for plantar heel pain. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group specialised register (September 2002), the Cochrane Central Register of Controlled Trials Register (The Cochrane Library issue 3, 2002), MEDLINE (1966 to September 2002), EMBASE (1988 to September 2002) and reference lists of articles and dissertations. Four podiatry journals were handsearched to 1998. We contacted all UK schools of podiatry to identify dissertations on the management of heel pain, and investigators in the field to identify unpublished data or research in progress. No language restrictions were applied. SELECTION CRITERIA: Randomised and quasi-randomised trials of interventions for plantar heel pain in adults. DATA COLLECTION AND ANALYSIS: Two reviewers independently evaluated randomised controlled trials for inclusion, extracted data and assessed trial quality. Additional information was obtained by direct contact with investigators. No poolable data were identified. Where measures of variance were available we have calculated the weighted mean differences based on visual analogue scale (VAS) scores. MAIN RESULTS: Nineteen randomised trials involving 1626 participants were included. Trial quality was generally poor, and pooling of data was not conducted. All trials measured heel pain as the primary outcome. Seven trials evaluated interventions against placebo/dummy or no treatment. There was limited evidence for the effectiveness of topical corticosteroid administered by iontophoresis, i.e. using an electric current, in reducing pain. There was some evidence for the effectiveness of injected corticosteroid providing temporary relief of pain. There was conflicting evidence for the effectiveness of low energy extracorporeal shock wave therapy in reducing night pain, resting pain and pressure pain in the short term (6 and 12 weeks) and therefore its effectiveness remains equivocal. In individuals with chronic pain (longer than six months), there was limited evidence for the effectiveness of dorsiflexion night splints in reducing pain. There was no evidence to support the effectiveness of therapeutic ultrasound, low-intensity laser therapy, exposure to an electron generating device or insoles with magnetic foil. No randomised trials evaluating surgery, or radiotherapy against a randomly allocated control population were identified. There was limited evidence for the superiority of corticosteroid injections over orthotic devices. AUTHORS' CONCLUSIONS: Although there is limited evidence for the effectiveness of local corticosteroid therapy, the effectiveness of other frequently employed treatments in altering the clinical course of plantar heel pain has not been established in randomised controlled trials.At the moment there is limited evidence upon which to base clinical practice. Treatments that are used to reduce heel pain seem to bring only marginal gains over no treatment and control therapies such as stretching exercises. Steroid injections are a popular method of treating the condition but only seem to be useful in the short term and only to a small degree. Orthoses should be cautiously prescribed for those patients who stand for long periods; there is limited evidence that stretching exercises and heel pads are associated with better outcomes than custom made orthoses in people who stand for more than eight hours per day.Well designed and conducted randomised trials are required.

No need to go! Workplace studies and the resources of the revised National Statement.

In their article 'Unintended consequences of human research ethics committees: au revoir workplace studies?', Greg Bamber and Jennifer Sappey set out some real obstacles in the practices and attitudes of some Human Research Ethics Committees (HRECs), to research in the social sciences and particulalry in industrial sociology. They sheet home these attitudes and practices to the way in which various statements in the NHMRC's National Statement [1999] are implemented, which they say is often in 'conflict with an important stream of industrial sociological research' in Australia. They do not discuss the recently completed revision of the NS. We undertake to show that the revised National Statement meets their concerns about research in industrial sociology, and to draw attention to the resources of the revised National Statement that engage with those concerns. A more general aim is to display the greater scope, in the revised National Statement, for researchers to show to HRECs that their research is justified by virutue of its reflecting the established methodology and traditions of their discipline. The revised National Statement, we suggest, provides for a more flexible and responsive approach than its predecessor to the ethical review of many areas of research.

Analysis of the reactions used for the preparation of drug candidate molecules.

The purpose of this perspective is to indicate the range of chemistries used in the manufacture of drug candidate molecules and to highlight certain gaps in current technologies. To do this a survey was carried out of chemical syntheses within the Process Chemistry R&D departments of GlaxoSmithKline, AstraZeneca and Pfizer.

Protecting health information privacy in research: what's an ethics committee like yours doing in a job like this?

The Commonwealth and State legislation designed to protect the privacy of personal health information has attracted the criticism that the constraints imposed on the use of the information in research obstructs that research. A central and common feature of the legislation is the reliance upon the review by human research ethics committees of research that proposes to use personal health information for research without prior consent from those whose information it is. The origins of this reliance are explored and explained and it is suggested that this has proved to be an inappropriate policy choice. The extension of the reliance is then described and the conceptual, procedural, workload and structural consequences of requiring these voluntary committees to conform to legislative standards of review of issues of the public interest are critically examined. In recent reviews of the Commonwealth legislation, there is recognition of the underlying uncertainty as to the appropriate balance between protection of personal privacy and the promotion of beneficial research. In the further exploration of these matters that those reviews recommended, a close and critical examination of the wisdom of continuing to rely on ethics committees is needed.

Protecting health information privacy in research: how much law do Australians need?

Privacy regulation in Australia, whether by federal or state legislation or other means, has provoked complaints from researchers. Its scope depends on defining the information it covers, the organisations it governs and the principles it applies. Regulation is inconsistent, and compliance can be complex (as illustrated by a hypothetical research example). National reform to achieve a realistic, balanced, publicly acceptable and consistent regulation is urgently needed, and has been recognised and recommended by recent reviews of the Commonwealth Privacy Act 1988 (Cwlth) by the Office of the Federal Privacy Commissioner and the Australian Senate.

Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial.

BACKGROUND: Arthrodesis is the current treatment for end-stage hallux rigidus, although there are many reports advocating total joint replacement arthroplasty. The aim of this randomized controlled trial was to evaluate clinical outcomes after first metatarsophalangeal joint (MTPJ) arthrodesis and replacement arthroplasty. METHODS: Between November, 1998, and January 2001, 63 patients between the ages of 34 and 77 years, with unilateral or bilateral MTPJ arthritis were recruited and randomly selected to have either MTPJ arthrodesis or arthroplasty. Twenty-two patients (38 toes) had arthrodesis and 27 patients (39 toes) had arthroplasty. A single surgeon performed all surgery. The primary outcome measure determining successful surgery was a decrease in pain as measured on a Visual Analogue Scale (VAS). Functional outcome was assessed at 6 months and 1 and 2 years. Cost data were simultaneously collected. RESULTS: At 24 months, pain improved in both groups (p < 0.001), but there were significantly greater improvements after arthrodesis (p = 0.01). All 38 arthrodeses united at a mean dorsiflexion angle of 26 degrees, with few complications. In contrast, in the arthroplasty group, six of the 39 inserted implants had to be removed because of phalangeal component loosening. In the remainder the range of motion gained was poor, and the patients tended to bear weight on the outer border of their foot. The cost ratio was 2:1 in favor of arthrodesis. CONCLUSIONS: Outcomes after arthrodesis were better than those after arthroplasty. The results were partially attributable to an unacceptably high incidence of loosening of the phalangeal components, which resulted in removal of the implants. However, even when data from the failures were excluded, arthrodesis was clearly preferred by most patients.

The effectiveness of extra corporeal shock wave therapy for plantar heel pain: a systematic review and meta-analysis.

BACKGROUND: There is considerable controversy regarding the effectiveness of extracorporeal shock wave therapy in the management of plantar heel pain. Our aim was to conduct a systematic review of randomised controlled trials to investigate the effectiveness of extracorporeal shock wave therapy and to produce a precise estimate of the likely benefits of this therapy. METHODS: We conducted a systematic review of all randomised controlled trials (RCTs) identified from the Cochrane Controlled trials register, MEDLINE, EMBASE and CINAHL from 1966 until September 2004. We included randomised trials which evaluated extracorporeal shock wave therapy used to treat plantar heel pain. Trials comparing extra corporeal shock wave therapy with placebo or different doses of extra corporeal shock wave therapy were considered for inclusion in the review. We independently applied the inclusion and exclusion criteria to each identified randomised controlled trial, extracted data and assessed the methodological quality of each trial. RESULTS: Six RCTs (n = 897) permitted a pooled estimate of effectiveness based on pain scores collected using 10 cm visual analogue scales for morning pain. The estimated weighted mean difference was 0.42 (95% confidence interval 0.02 to 0.83) representing less than 0.5 cm on a visual analogue scale. There was no evidence of heterogeneity and a fixed effects model was used. CONCLUSION: A meta-analysis of data from six randomised-controlled trials that included a total of 897 patients was statistically significant in favour of extracorporeal shock wave therapy for the treatment of plantar heel pain but the effect size was very small. A sensitivity analysis including only high quality trials did not detect a statistically significant effect.