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Results for “randomized controlled trial (RCT)”

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PubMed2026

Anti-inflammatory agents after hip and shoulder arthroplasty: A systematic review and meta-analysis.

BACKGROUND: Postoperative inflammation after arthroplasty contributes to pain, delayed mobilization and prolonged hospitalization. Recent randomized trials have evaluated pharmacological anti-inflammatory strategies within contemporary enhanced recovery pathways, but evidence after hip and shoulder arthroplasty remains scattered across different drug classes and perioperative regimens. OBJECTIVES: To synthesize recent randomized controlled trial (RCT) evidence on perioperative anti-inflammatory agents after hip and shoulder arthroplasty. METHODS: PubMed, Embase, Cochrane Library and Web of Science were searched for English-language RCTs published from January 2020 to March 2026. The 2020-2026 window was selected to update evidence generated under modern arthroplasty, anesthesia, multimodal analgesia and enhanced recovery after surgery (ERAS) pathways. Eligible trials included adults undergoing hip or shoulder arthroplasty and compared corticosteroids, cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drug (NSAID)-based/local anti-inflammatory regimens, or related anti-inflammatory interventions with placebo, saline, no treatment, or the same regimen without the target component. Weighted mean differences (WMDs) were pooled using random-effects models. RESULTS: Nine RCTs involving 800 patients were included. Anti-inflammatory interventions significantly reduced postoperative C-reactive protein (CRP) [WMD=-32.18, 95% confidence interval (CI) (-41.16, -23.21), P<0.001], interleukin-6 (IL-6) [WMD=-31.25, 95% CI (-41.79, -20.77), P<0.001], rest pain [WMD=-0.41, 95% CI (-0.58, -0.23), P<0.001], activity pain [WMD=-0.56, 95% CI (-0.83, -0.29), P<0.001] and hospital stay [WMD=-0.54, 95% CI (-0.92, -0.15), P=0.006]. CONCLUSION: Recent RCT evidence suggests that perioperative anti-inflammatory interventions can attenuate early inflammatory responses and improve short-term pain and recovery after hip and shoulder arthroplasty. Because data were limited and clinically heterogeneous, the findings should not be interpreted as evidence favoring a specific drug class, dose, route, or timing.

Humans↗

PubMed2005

The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001.

To comprehend the result of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this article incorporates new evidence and addresses some criticism of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage or participants through an RCT. The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up and analysis). The diagram explicitly includes the number of participants, according to each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting or an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Guidelines as Topic↗

PubMed2004

Back schools in occupational health care: design of a randomized controlled trial and cost-effectiveness study.

OBJECTIVE: To describe the design of a randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing high-intensity and low-intensity back schools with usual care in occupational health care. DESIGN: RCT and cost-effectiveness analysis. STUDY POPULATION: Employees sick-listed for a period of 3 to 6 weeks because of nonspecific low back pain. Interventions High-intensity back school treatment consists of a training program based on the principles of cognitive-behavioral therapy. Low-intensity back school treatment is comparable to the original Swedish Back School. Usual care is provided by the occupational physician according to the Dutch guidelines for the occupational health treatment of patients with low back pain. OUTCOME MEASURES: Primary outcome measures are return to work, pain intensity, functional status, and general improvement. Secondary outcome measures are kinesiophobia and pain coping. The cost-effectiveness analysis includes the direct and indirect costs. The outcome measures are assessed before randomization and 3, 6, and 12 months after randomization. CONCLUSION: RCTs of different methodological quality have been conducted to examine the effectiveness of back schools in occupational health care. The large variation in type, content, and intensity of back schools has led to conflicting evidence. Therefore, 2 different forms of back schools are compared. Moreover, this is the first RCT to include a cost-effectiveness analysis comparing low-intensity and high-intensity back schools with usual care in occupational health care.

Adolescent↗

PubMedDate not supplied

RCT of a care manager intervention for major depression in primary care: 2-year costs for patients with physical vs psychological complaints.

PURPOSE: Depression care management for primary care patients results in sustained improvement in clinical outcomes with diminishing costs over time. Clinical benefits, however, are concentrated primarily in patients who report to their primary care clinicians psychological rather than exclusively physical symptoms. This study proposes to determine whether the intervention affects outpatient costs differentially when comparing patients who have psychological with patients who have physical complaints. METHODS: We undertook a group-randomized controlled trial (RCT) of depression comparing intervention with usual care in 12 primary care practices. Intervention practices encouraged depressed patients to engage in active treatment, using nurses to provide regularly scheduled care management for 24 months. The study sample included 200 adults beginning a new depression treatment episode where patient presentation style could be identified. Outpatient costs were defined as intervention plus outpatient treatment costs for the 2 years. Cost-offset analysis used general linear mixed models, 2-part models, and bootstrapping to test hypotheses regarding a differential intervention effect by patients' style, and to obtain 95% confidence intervals for costs. RESULTS: Intervention effects on outpatient costs over time differed by patient style (P <.05), resulting in a $980 cost decrease for depressed patients who complain of psychological symptoms and a 1,378 dollars cost increase for depressed patients who complain of physical symptoms only. CONCLUSIONS: Depression intervention for a 2-year period produced observable clinical benefit with decreased outpatient costs for depressed patients who complain of psychological symptoms. It produced limited clinical benefit with increased costs, however, for depressed patients who complain exclusively of physical symptoms, suggesting the need for developing new intervention approaches for this group.

Adult↗

PubMed2003

Design and quality control issues related to dietary assessment, randomized clinical trials and meta-analysis of field-based studies in developing countries.

The essential design and quality control aspects of dietary assessment, randomized controlled trials (RCT) in developing countries and their subsequent meta-analysis are reviewed. Dietary assessment protocols consist of three stages: measurement of food intakes using a method appropriate for the study objectives, calculation of nutrient intakes and finally an evaluation of their nutrient adequacy. The latter may involve: 1) assessment of dietary diversity (average number of different foods consumed per day) and selected indices of dietary quality such as intakes of animal source foods (g/d); 2) percentage of energy from protein, fat and animal protein; 3) selected nutrient densities; and 4) dietary phytate:zinc molar ratio, as well as the prevalence of inadequate nutrient intakes calculated using a probability approach. To establish causality between the nutrient inadequacies identified and adverse health outcomes, RCT must be undertaken. A prerequisite of RCT is double-blind randomization, a procedure designed to eliminate biases arising from baseline confounding variables, unintended interventions and ascertainment bias. Results from existing RCT can be summarized via meta-analysis to gain a better understanding of the population relationship. Meta-analysis is a statistical technique involving linear models or generalized linear models, which can be performed after locating the individual studies, and selecting and abstracting all the necessary data.

Developing Countries↗

PubMed1996

A pilot study for a randomized controlled trial to prevent gastric cancer in high-risk Japanese population: study design and feasibility evaluation.

Observational epidemiological studies suggest that some nutrients reduce the risk of gastric cancer and that individuals with atrophic gastritis are at high risk of developing gastric cancer. One possible measure for gastric cancer prevention is therefore nutritional supplementation for the high risk group. Before recommending this strategy for the general public, however, a randomized controlled trial (RCT) is necessary. To evaluate the feasibility of an RCT, the authors conducted a pilot study using recipients of a health check-up program in a general hospital in Japan. The subjects who were asked to participate in the trial had been diagnosed as having atrophic gastritis on the basis of serum pepsinogen I < 70 ng/ml and the ratio of pepsinogen I to II < 3.0. They were requested to ingest double-blinded capsules containing different levels of vitamin C and beta-carotene every day. Out of the 219 subjects (118 males, 101 females) who were eligible for the study and had the required pepsinogen measurement, 90 (41%) met the criteria for atrophic gastritis. Among them, 55 (61%) (35 males, 20 females) gave their informed consent to participate in the RCT. Fifty-four participants completed a 3-month course of supplementation, and all of them agreed to a 5-year supplementation period. The authors concluded that an RCT using double-blinded nutritional supplements and targeting apparently healthy individuals is feasible in an intervention study for cancer prevention in Japan.

Adult↗

PubMed2002

Can we individualize the 'number needed to treat'? An empirical study of summary effect measures in meta-analyses.

BACKGROUND: Meta-analyses summarize the magnitude of treatment effect using a number of measures of association, including the odds ratio (OR), risk ratio (RR), risk difference (RD) and/or number needed to treat (NNT). In applying the results of a meta-analysis to individual patients, some textbooks of evidence-based medicine advocate individualizing NNT, based on the RR and the patient's expected event rate (PEER). This approach assumes constant RR but no empirical study to date has examined the validity of this assumption. METHODS: We randomly selected a subset of meta-analyses from a recent issue of the Cochrane Library (1998, Issue 3). When a meta-analysis pooled more than three randomized controlled trials (RCT) to produce a summary measure for an outcome, we compared the OR, RR and RD of each RCT with the corresponding pooled OR, RR and RD from the meta-analysis of all the other RCT. Using the conventional P-value of 0.05, we calculated the percentage of comparisons in which there were no statistically significant differences in the estimates of OR, RR or RD, and refer to this percentage as the 'concordance rate'. RESULTS: For each effect measure, we made 1843 comparisons, extracted from 55 meta-analyses. The random effects model OR had the highest concordance rate, closely followed by the fixed effects model OR and random effects model RR. The minimum concordance rate for these indices was 82%, even when the baseline risk differed substantially. The concordance rates for RD, either fixed effects or random effects model, were substantially lower (54-65%). CONCLUSIONS: The fixed effects OR, random effects OR and random effects RR appear to be reasonably constant across different baseline risks. Given the interpretational and arithmetic ease of RR, clinicians may wish to rely on the random effects model RR and use the PEER to individualize NNT when they apply the results of a meta-analysis in their practice.

Evidence-Based Medicine↗

PubMed2000

Is long-term weight loss possible?

Any intervention which causes negative energy balance is guaranteed to be efficacious in producing weight loss, which will continue while there is negative energy balance or be maintained as long as the new energy balance is maintained. In clinical practice compliance is rarely 100% so the efficiency of even the most efficacious treatment is usually low. However, recent evidence-based guidelines have recognized the clinical benefits of moderate (5-10%) weight loss, which is achievable using a variety of interventions. Long-term studies of 'weight loss' are, in reality, combinations of weight loss (usually completed in 1-6 months) followed by variable weight maintenance, set in the context of progressive adult weight gain in an obesogenic environment. Few studies have adopted specific and separate strategies for weight loss and weight maintenance. Meta-analyses conducted by non-expert methodologists have failed to recognize these distinctions, and have criticized the available research without understanding the different needs of studies with weight change as the outcome variable, which require randomized controlled trials (RCT), and those with weight loss as the treatment, intended to improve metabolic or biomedical outcome measures. An RCT design is inapplicable to studies of biomedical end points (e.g. cardiac risk factors) when weight loss is the treatment. Because fixed weight loss cannot be prescribed there is always a range of weight changes in any study, and single-sample studies with regression analysis provide the best design. An RCT study design does not give useful information about clinical value as the control group is always 'treated' to some extent. Placebo- (or control)-subtracted differences are misleading because in an RCT all subjects recruited to active treatment, including non-responders, are continued on treatment for the full duration of the study. In routine clinical practice, treatments are changed in the light of early experience as a therapeutic trial to optimize the results for each individual, and audit is required to evaluate 'long term weight loss'.

Adult↗

PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗

PubMedDate not supplied

Esophageal cancer surgery: the value of controlled clinical trials.

Prospective randomized controlled trials (RCT) in esophageal cancer were reviewed. Their value and significance in the areas of multimodality therapy, lymphadenectomy, surgical techniques, palliative treatments, and perioperative management were evaluated. Much has been gained through RCT in the management of esophageal cancer, and RCT is the most reliable scientific method in clinical investigations. Problems in the conduct of such trials include lack of expertise by surgeons, lack of patients, lack of funding, and methodologic and ethical problems. These obstacles could be overcome and more well-conducted RCTs encouraged.

Adenocarcinoma↗

PubMed2004

Historiography taking issue: analyzing an experiment with heroin abusers.

This article discusses the predicament of historians becoming part of the history they are investigating and illustrates the issue in a particular case. The case is that of the randomized controlled trial (RCT)-more specifically, its use for testing the effects of providing heroin to severe heroin abusers. I counter the established view of the RCT as a matter of timeless logic and argue that this research design was developed in the context of administrative knowledge making under twentieth-century economic liberalism of which it epitomizes some central values. I also argue that the applicability of the RCT depends on the degree to which its advocates can define the issue to be studied according to its inherent values. Next, I demonstrate how advocates of an RCT with heroin provision in the Netherlands steered the political discussion on heroin provision and how the values of economic liberalism also shaped the results of the Dutch maintenance experiment. In addition, I relate how my analysis of this experiment became part of political debates in the Netherlands. Contrary to my intentions, adversaries of heroin maintenance used my critique on the heroin RCT as an argument against heroin maintenance. Such risks are inherent to historiography and sociology of science aiming at practical relevance while challenging treasured scientific beliefs. I conclude that it still seems better to expose arguments on unjustified certainties than to suppress them for strategic reasons.

Heroin↗

PubMed2005

Daily functioning and quality of life in a randomized controlled trial of therapeutic exercise for subacute stroke survivors.

BACKGROUND AND PURPOSE: The ability of therapeutic exercise after stroke to improve daily functioning and quality of life (QOL) remains controversial. We examined treatment effects on these outcomes in a randomized controlled trial (RCT) of exercise in subacute stroke survivors. METHODS: This is a secondary analysis of a single-blind RCT of a 12-week program versus usual care. Baseline, post-treatment and 6-month post-treatment daily functioning and QOL were assessed by Barthel index, Functional Independence Measure, instrumental activities of daily living, Medical Outcomes Study short-form 36-item questionnaire (SF-36), and Stroke Impact Scale (SIS). RESULTS: Of 100 randomized subjects, 93 completed the postintervention assessment, (mean age 70; 54% male; 81% white; mean Orpington Prognostic Score 3.4), and 80 had 6-month post-treatment assessment. Immediately after intervention, the intervention group improved more than usual care in SF-36 social function (14.0 points; P=0.0051) and in SIS (strength [9.2 points; P=0.0003], emotion [5.6 points; P=0.0240], social participation [6.6 points; P=0.0488], and physical function [5.0 points; P=0.0145]). Treatment was marginally more effective on Barthel score (3.3 points; P=0.0510), SF-36 (physical function [6.8 points; P=0.0586], physical role function [14.4 points; P=0.0708]), and SIS upper extremity function (7.2 points; P=0.0790). Effects were diluted 6 months after treatment ended. CONCLUSIONS: This rehabilitation exercise program led to more rapid improvement in aspects of physical, social, and role function than usual care in persons with subacute stroke. Adherence interventions to promote continued exercise after treatment might be needed to continue benefit.

Activities of Daily Living↗

PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Con solidated S tandards o f R eporting T rials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Algorithms↗

PubMed1995

A survey of endpoint characteristics in periodontal clinical trials published 1988-1992, and implications for future studies.

Endpoints are conditions or events that are associated with individual study subjects and that are used to assess treatment efficacy. 2 types of endpoints can be distinguished: "true" endpoints (reflect unequivocal evidence of tangible benefit to the patient) and "surrogate" endpoints (usually a measure of disease process). The purpose of this study was to survey four aspects of endpoint usage in randomized controlled trials (RCT's) on the treatment of periodontitis: (1) the typical number of endpoints per RCT, (2) the proportion of RCTs using the same endpoint, (3) the proportion of RCTs using true endpoints, and (4) whether treatment choice influenced endpoint choice. 92 publications (1988-1992) reporting on 82 RCT's were identified. The typical number of endpoints per RCT was 6 (range: 1-28). The 3 most frequently used endpoints were mean probing depth (78% of the trials), mean probing attachment level (66%), and the plaque index (37%). In total, 153 distinct surrogate endpoints were defined. Most of these were used infrequently; over 80% of the 153 endpoints were used in fewer than 5 of the 82 trials. No trials used tooth loss as a true endpoint. In the design of an RCT, treatment choice influenced surrogate endpoint choice. Surrogate endpoints based on re-entry surgery were exclusively used for regenerative procedures and microbiological surrogate endpoints were mostly used for RCT's on anti-microbials. The conclusion is that the typical RCT used multiple surrogate endpoints, some of which were used infrequently by other trials. Such endpoint usage characteristics are suitable for exploratory RCTs (designed to identify active treatments or to elucidate treatment mechanisms). The question is raised as to whether periodontal research has reached the point of needing properly designed definitive studies, whose purpose it would be to provide unequivocal evidence of tangible benefits to the patient by the various treatments. If a need for definitive randomized controlled trials is perceived, then the use of (multiple) surrogate endpoints as primary outcomes should be questioned. Surrogate endpoint usage has led to both false positive and false negative conclusions in other chronic disease studies. Endpoint selection and validation in RCTs may be an important element in resolving controversies about periodontal treatments.

Humans↗

PubMed2005

Cardiac medical therapy in patients after undergoing coronary artery bypass graft surgery: a review of randomized controlled trials.

The purpose of this paper is to review the randomized controlled trial (RCT) data investigating cardiac medical therapy for patients after coronary artery bypass grafting (CABG). We identified RCTs with > or =100 enrolled patients that examined the impact of cardiac medical therapy on outcomes > or =1 year after CABG. The MEDLINE database was searched for trials conducted between 1966 and 2004 on the following medications: aspirin, antilipid agents, beta-blockers, calcium channel blockers (CCBs), nitrates, and angiotensin-converting enzyme (ACE) inhibitors. Both aspirin and antilipid agents were found to reduce the progression of atherosclerosis and the occurrence of graft occlusion. Cardiovascular events were decreased with antilipid agents. In small trials, beta-blockers and CCBs failed to decrease the incidence of cardiovascular events. No RCTs examined nitrates, and one small RCT documented a reduction in cardiovascular events among patients treated with ACE inhibitors. We conclude that few RCTs have examined the efficacy of cardiac medical therapy in post-CABG patients. Based on current RCT evidence, aspirin and antilipid agents should be used routinely after CABG. However, current data do not support the use of beta-blockers, CCBs, and nitrates, and more evidence is needed regarding the use of ACE inhibitors.

Adrenergic beta-Antagonists↗

PubMed1995

Unbiased research and the human spirit: the challenges of randomized controlled trials.

Research by Klein and associates provides useful information on the relation between episiotomy and outcomes such as perineal trauma, but the methodologic implications of their work are especially fascinating. Physicians who participated in their randomized controlled trial (RCT) were supposed to adhere to a policy of either liberal or restrictive use of episiotomy according to the study arm to which each patient was assigned. However, some used the procedure for approximately 90% of patients regardless of allocation. Klein and associates' post-hoc study (see pages 769 to 779 of this issue) sheds light on the relation between physician attitudes and the practice of episiotomy. The author contends that the noncompliance encountered by Klein and associates reflects the fact that randomized trials are anathema to the human spirit. He offers suggestions for making RCTs more meaningful and stresses that, although RCTs are indispensible to the advancement of medical knowledge, they necessitate assiduous attention to matters of design and implementation.

Attitude of Health Personnel↗

PubMed2005

Investigation of staff and patients' opinions of a proposed trial of elective single embryo transfer.

BACKGROUND: In the context of mounting concern about the risks of twin pregnancies resulting from IVF, this study aimed to assess staff and patients' attitudes towards a proposed randomized controlled trial (RCT) of elective single embryo transfer (SET) in a Scottish fertility centre. METHODS: The views of 10 members of IVF clinic staff were assessed by means of a focus group and those of 12 couples by semi-structured interviews. RESULTS: Staff were aware of the risks of twin pregnancies to mothers and babies and the need for evidence of success in SET, but had reservations about the proposed RCT. The need to subject patients to unpopular scientific procedures such as randomization and blinding conflicted with their perceived caring role. They felt it would be hard to recruit and onerous to patients but nevertheless discussed how it could be successfully mounted if necessary. They debated how to ensure that consent was fully informed, and when, and how, to randomize. Patients accepted the possibility of twins but were largely unaware of risks inherent in twin pregnancies. They saw no need for a trial and found the idea of randomization unacceptable except in younger women. They would accept SET if it became unit policy and appeared unaffected by financial considerations. CONCLUSIONS: Involving affected staff at the design stage may make it easier to conduct a SET trial in their clinics. IVF patients whose ultimate goal is pregnancy are less likely to support a trial which aims to minimize twin pregnancies.

Adult↗

PubMed2003

Efficacy of massage therapy in chronic pain: a pragmatic randomized trial.

BACKGROUND: Although classic massage is used widely in Germany and elsewhere for treating chronic pain conditions, there are no randomized controlled trials (RCT). DESIGN: Pragmatic RCT of classic massage compared to standard medical care (SMC) in chronic pain conditions of back, neck, shoulders, head and limbs. OUTCOME MEASURE: Pain rating (nine-point Likert-scale; predefined main outcome criterion) at pretreatment, post-treatment, and 3 month follow-up, as well as pain adjective list, depression, anxiety, mood, and body concept. RESULTS: Because of political and organizational problems, only 29 patients were randomized, 19 to receive massage, 10 to SMC. Pain improved significantly in both groups, but only in the massage group was it still significantly improved at follow-up. Depression and anxiety were improved significantly by both treatments, yet only in the massage group maintained at follow-up. CONCLUSION: Despite its limitation resulting from problems with numbers and randomization this study shows that massage can be at least as effective as SMC in chronic pain syndromes. Relative changes are equal, but tend to last longer and to generalize more into psychologic domains. Because this is a pilot study, the results need replication, but our experiences might be useful for other researchers.

Adult↗