Long-term trajectories of patients with neck pain and low back pain presenting to chiropractic care: A latent class growth analysis.

BACKGROUND: Information on the course of neck pain (NP) and low back pain (LBP) typically relies on data collected at few time intervals during a period of up to 1 year. METHODS: In this prospective, multicentre practice-based cohort study, patients consulting a chiropractor responded weekly for 52 weeks to text messages on their cell phones. Data from 448 patients (153 NP, 295 LBP) who had returned at least one set of answers in the first 26 weeks were used. Outcome measures were pain intensity (VAS) and functional outcome, assessed using four different questions: pain intensity, limitation in activities of daily living (ADL), number of days with pain in the previous week and number of days limited in ADL. Distinct patterns of pain were analysed with quadratic latent class growth analysis. RESULTS: The final model was a 4-class model for NP and LBP. The 'recovering from mild baseline pain' is most common (76.3% of NP patients/58.3% of LBP patients) followed by the 'recovering from severe baseline pain' class (16.3% NP/29.8% LBP). They follow similar trajectories when considered over a period of 6 months. Pain at baseline, duration of complaints, functional status, limitations in ADL and the score on psychosocial scales were the variables that most contributed to distinguish between groups. CONCLUSIONS: Most patients with NP or LBP presenting in chiropractic care show a trajectory of symptoms characterized by persistent or fluctuating pain of low or medium intensity. Only a minority either experience a rapid complete recovery or develop chronic severe pain. SIGNIFICANCE: Ninety percentage of patients with neck pain or low back pain presenting to chiropractors have a 30% improvement within 6 weeks and then show a trajectory of symptoms characterized by persistent or fluctuating pain of low or medium intensity. Only a minority either experience a rapid complete recovery or develop chronic severe pain.

Somatization is associated with worse outcome in a chiropractic patient population with neck pain and low back pain.

AIM: To determine if psychosocial factors are associated with outcome in patients with neck pain or low back pain. METHODS: In a prospective, multi-center chiropractic practice-based cohort study in Belgium and The Netherlands, 917 patients, of which 326 with neck pain and 591 with low back pain, completed self-administered questionnaires at baseline, following the second visit, and at 1, 3, 6 and 12 months. Psychosocial factors assessed at baseline were: distress, depression, anxiety and somatization via the Four Dimensional Symptom Questionnaire, patient's beliefs regarding the effect of physical activity and work on their complaint via the Fear Avoidance Beliefs Questionnaire, and social support via the Feij social support scale. Primary outcome measures were perceived recovery, pain intensity, and functional status which was measured with the Neck Disability Index and Oswestry Disability Index. A univariable regression analysis to estimate the relation between each psychological variable and outcome was followed by a multivariable multilevel regression analysis. RESULTS: There were no differences in baseline patient characteristics between the patient population from Belgium and the Netherlands. Somatization scores are consistently associated with perceived recovery, functional status and pain for both neck pain and low-back pain. Depression was associated with poorer functioning in patients with LBP. There was a small association between fear and function and pain for patients with neck pain or low-back pain. CONCLUSION: Somatization was the only variable consistently found to be associated with diminished perceived recovery, higher degree of neck or low back disability, and increased neck or low back pain.

Balneotherapy (or spa therapy) for rheumatoid arthritis. An abridged version of Cochrane Systematic Review.

BACKGROUND: Treatment options for rheumatoid arthritis (RA) include pharmacological interventions, physical therapy treatments and balneotherapy. AIM: To evaluate the benefits and harms of balneotherapy in patients with RA. DESIGN: A systematic review. POPULATION: Studies were eligible if they were randomised controlled trials consisting of participants with definitive or classical RA. METHODS: We searched various databases up to December 2014. Balneotherapy had to be the intervention under study, and had to be compared with another intervention or with no intervention. We considered pain, improvement, disability, tender joints, swollen joints and adverse events among the main outcome measures. We excluded studies when only laboratory variables were reported as outcome measures. Two review authors independently selected trials, performed data extraction and assessed risk of bias. RESULTS: This review includes nine studies involving 579 participants. Most studies showed an unclear risk of bias in most domains. We found no statistically significant differences on pain or improvement between mudpacks versus placebo (1 study; N.=45; hand RA; very low level of evidence). As for the effectiveness of additional radon in carbon dioxide baths, we found no statistically significant differences between groups for all outcomes at three-month follow-up (2 studies; N.=194; low to moderate level of evidence). We noted some benefit of additional radon at six months in pain (moderate level of evidence). One study (N.=148) compared balneotherapy (seated immersion) versus hydrotherapy (exercises in water), land exercises or relaxation therapy. We found no statistically significant differences in pain or in physical disability (very low level of evidence) between groups. We found no statistically significant differences in pain intensity at eight weeks, but some benefit of mineral baths in overall improvement at eight weeks compared to Cyclosporin A (1 study; N.=57; low level of evidence). CONCLUSION: Overall evidence is insufficient to show that balneotherapy is more effective than no treatment; that one type of bath is more effective than another or that one type of bath is more effective than exercise or relaxation therapy. CLINICAL REHABILITATION IMPACT: We were not able to assess any clinical relevant impact of balneotherapy over placebo, no treatment or other treatments.

Balneotherapy for osteoarthritis.

BACKGROUND: Balneotherapy (or spa therapy, mineral baths) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain and as a consequence to relieve patients' suffering and make them feel well. In this update we included one extra study. OBJECTIVES: To assess the effectiveness of balneotherapy for patients with osteoarthritis (OA). SEARCH STRATEGY: We searched the following databases up to October 2006: EMBASE, PubMed, the Cochrane 'Rehabilitation and Related Therapies' Field database, PEDro, CENTRAL (Issue 3, 2006) and performed reference checking and communicated with authors to retrieve eligible studies. SELECTION CRITERIA: Randomised controlled trials (RCT) comparing balneotherapy with any intervention or no intervention. At least 90% of the patient population had to be diagnosed with OA. DATA COLLECTION AND ANALYSIS: Two authors independently assessed quality and extracted data. Disagreements were solved by consensus. In the event of clinical heterogeneity or lack of data we refrained from statistical pooling. MAIN RESULTS: Seven trials (498 patients) were included in this review. Two studies compared spa-treatment with no treatment. One study evaluated baths as an add-on treatment to home exercises and another compared thermal water from Cserkeszölö with tap water (placebo). Three studies evaluated sulphur or Dead Sea baths with no treatment or mineral baths with tap water baths or no treatment. Only one of the trials performed an intention-to-treat analysis and two studies provided data to perform an intention-to-treat analysis ourselves. A 'quality of life' outcome was reported by one trial. We found: silver level evidence concerning the beneficial effects on pain, quality of life and analgesic intake of mineral baths compared to no treatment (SMD between 1.82 and 0.34). a statistically significant difference in pain and function of Dead Sea + sulphur versus no treatment, only at end of treatment (WMD 5.7, 95%CI 3.3 to 8.1), but not at 3 month follow-up (WMD 2.6, 95%CI -1.1 to 6.3). no statistically significant differences in pain or function at one or three months of Dead Sea baths versus no treatment (WMD 0.5, 95%CI -0.6 to 1.6) or at one or three months of sulphur baths versus no treatment (WMD 0.4, 95%CI -0.9 to 1.7). Adverse events were not measured in the included trials. AUTHORS' CONCLUSIONS: We found silver level evidence (www.cochranemsk.org) concerning the beneficial effects of mineral baths compared to no treatment. Of all other balneological treatments no clear effects were found. However, the scientific evidence is weak because of the poor methodological quality and the absence of an adequate statistical analysis and data presentation. Therefore, the noted "positive findings" should be viewed with caution.

Ergonomic and physiotherapeutic interventions for treating work-related complaints of the arm, neck or shoulder in adults. A Cochrane systematic review.

BACKGROUND: Conservative interventions such as physiotherapy and ergonomic adjustments (such as keyboard adjustments or ergonomic advice) play a major role in the treatment of most work-related complaints of the arm, neck or shoulder (CANS). Objectives. This systematic review aims to determine whether conservative interventions have a significant impact on outcomes for work-related CANS in adults. Search strategy. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2005) and Cochrane Rehabilitation and Related Therapies Field Specialised Register (March 2005), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2005), PubMed, EMBASE, CINAHL, AMED and reference lists of articles. The date of the last search was March 2005. No language restrictions were applied. Selection criteria. We included randomised controlled trials and concurrent controlled trials studying conservative interventions (e.g. exercises, relaxation, physical applications, biofeedback, myofeedback and work-place adjustments) for adults suffering CANS. Data collection and analysis. Two authors independently selected trials from the search yield, assessed the methodological quality using the Delphi list, and extracted relevant data. We pooled data or, in the event of clinical heterogeneity or lack of data, we used a rating system to assess levels of evidence. MAIN RESULTS: For this update we included six additional studies; twenty-one trials in total. Seventeen trials included people with chronic nonspecific neck or shoulder complaints, or nonspecific upper extremity disorders. Over twenty-five interventions were evaluated; six main subgroups of interventions could be determined: exercises, manual therapy, massage, ergonomics, energised splint and individual treatment versus group therapy. Overall, the quality of the studies was poor. In 14 studies a form of exercise was evaluated, and contrary to the previous review we now found limited evidence about the effectiveness of exercises when compared to massage and conflicting evidence when exercises are compared to no treatment. In this update there is limited evidence for adding breaks during computer work; massage as add-on treatment on manual therapy, manual therapy as add-on treatment on exercises; and some keyboard designs when compared to other keyboards or placebo in participants with carpal tunnel syndrome. CONCLUSIONS: There is limited evidence for the effectiveness of keyboards with an alternative force-displacement of the keys or an alternative geometry, and limited evidence for the effectiveness of exercises compared to massage, breaks during computer work compared to no breaks; massage as an add-on treatment to manual therapy, and manual therapy as an add-on treatment to exercises.

Ergonomic and physiotherapeutic interventions for treating work-related complaints of the arm, neck or shoulder in adults.

BACKGROUND: Conservative interventions such as physiotherapy and ergonomic adjustments (such as keyboard adjustments or ergonomic advice) play a major role in the treatment of most work-related complaints of the arm, neck or shoulder (CANS). OBJECTIVES: This systematic review aims to determine whether conservative interventions have a significant impact on outcomes for work-related CANS in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2005) and Cochrane Rehabilitation and Related Therapies Field Specialised Register (March 2005), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2005), PubMed, EMBASE, CINAHL, AMED and reference lists of articles. The date of the last search was March 2005. No language restrictions were applied. SELECTION CRITERIA: We included randomised and non-randomised controlled trials studying conservative interventions (e.g. exercises, relaxation, physical applications, biofeedback, myofeedback and work-place adjustments) for adults suffering CANS. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials from the search yield, assessed the methodological quality using the Delphi list, and extracted relevant data. We pooled data or, in the event of clinical heterogeneity or lack of data, we used a rating system to assess levels of evidence. MAIN RESULTS: For this update we included six additional studies; 21 trials in total. Seventeen trials included people with chronic non-specific neck or shoulder complaints, or non-specific upper extremity disorders. Over 25 interventions were evaluated; five main subgroups of interventions could be determined: exercises, manual therapy, massage, ergonomics, and energised splint. Overall, the quality of the studies was poor. In 14 studies a form of exercise was evaluated, and contrary to the previous review we now found limited evidence about the effectiveness of exercises when compared to massage and conflicting evidence when exercises are compared to no treatment. In this update there is limited evidence for adding breaks during computer work; massage as add-on treatment on manual therapy, manual therapy as add-on treatment on exercises; and some keyboard designs when compared to other keyboards or placebo in participants with carpal tunnel syndrome. AUTHORS' CONCLUSIONS: There is limited evidence for the effectiveness of keyboards with an alternative force-displacement of the keys or an alternative geometry, and limited evidence for the effectiveness of exercises compared to massage; breaks during computer work compared to no breaks; massage as an add-on treatment to manual therapy; and manual therapy as an add-on treatment to exercises.

[The use of complementary and alternative medicine in children: how to advise the parents?]. / Het gebruik van complementaire en alternatieve geneeswijzen bij kinderen: hoe de ouders te adviseren?

Recently it has been shown that complementary or alternative medicine (CAM) is used in about 30% of paediatric patients. Is this a problem? It has also been shown that most parents would like their paediatrician to advise them on the subject. But what can be the basis of such advice? Little is known and less has been published regarding the effectiveness of CAM. Society and the medical profession are notoriously ambiguous on the subject. Sound scientific evidence is advocated to make bold decisions on whether to allow and reimburse the use of CAM.

Ergonomic and physiotherapeutic interventions for treating upper extremity work related disorders in adults.

BACKGROUND: Conservative interventions such as physiotherapy and ergonomic adjustments play a major part in the treatment of most work-related musculoskeletal disorders (WRMD). OBJECTIVES: The objective of this systematic review is to determine whether conservative interventions have a significant impact on short and long-term outcomes for upper extremity WRMD in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (January 2002) and Cochrane Rehabilitation and Related Therapies Field specialised register (January 2002), the Cochrane Controlled Trials Register (The Cochrane Library Issue 3, 2001), PubMed (1966 to November 2001), EMBASE (1988 to November 2001), and CINAHL (1982 to November 2001). We also searched the Physiotherapy Index (1988 to November 2001) and reference lists of articles. No language restrictions were applied. SELECTION CRITERIA: Only randomised controlled trials and concurrent controlled trials studying conservative interventions for adults suffering from upper extremity WRMD were included. Conservative interventions may include exercises, relaxation, physical applications, biofeedback, myofeedback and work place adjustments. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected the trials from the search yield and assessed the clinical relevance and methodological quality using the Delphi list. In the event of clinical heterogeneity or lack of data we used a rating system to assess levels of evidence. MAIN RESULTS: We included 15 trials involving 925 people. Twelve trials included people with chronic non-specific neck or shoulder complaints, or non-specific upper extremity disorders. Over 20 interventions were evaluated; seven main subgroups of interventions could be determined: exercises, manual therapy, massage, ergonomics, multidisciplinary treatment, energised splint and individual treatment versus group therapy. Overall, the quality of the studies appeared to be poor. In 10 studies a form of exercise was evaluated, and there is limited evidence about the effectiveness of exercises only when compared to no treatment. Concerning manual therapy (1 study), massage (4 studies), multidisciplinary treatment (1 study) and energised splint (1 study) no conclusions can be drawn. Limited evidence is found concerning the effectiveness of specific keyboards for patients with carpal tunnel syndrome. REVIEWER'S CONCLUSIONS: This review shows limited evidence for the effectiveness of keyboards with an alternative force-displacement of the keys or an alternative geometry, and limited evidence for the effectiveness of individual exercises. The benefit of expensive ergonomic interventions (such as new chairs, new desks etc) in the workplace is not clearly demonstrated.

Balneotherapy for rheumatoid arthritis.

BACKGROUND: Balneotherapy (spa therapy) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain, improve joint motion and as a consequence to relieve people' suffering and make them feel well. OBJECTIVES: To perform a systematic review on the effectiveness of balneotherapy for rheumatoid arthritis. SEARCH STRATEGY: Using the Cochrane search strategy, studies were found by screening: 1) The MEDLINE CD-ROM database from 1966 to June 2002 and 2) the database from the Cochrane 'Rehabilitation and Related Therapies' Field, the Pedro database up to June 2002. Also, 3) reference checking and 4) personal communications with authors was carried out to retrieve eligible studies. Date of the most recent literature search: June, 2002 SELECTION CRITERIA: Studies were eligible if they were randomised controlled trials (RCTs) comparing balneotherapy with any other intervention or with no intervention. Included participants all suffered from definite or classical rheumatoid arthritis (RA) as defined by the American Rheumatism Association Criteria (ARA) or by the criteria of Steinbrocker. At least one of the WHO/ILAR core set of endpoints for RA clinical trials had to be among the main outcome measures. DATA COLLECTION AND ANALYSIS: The Delphi list was the criteria list used to assess the components of methodological quality. Two reviewers carried out quality assessment and data extraction of the studies. Disagreements were solved by consensus. MAIN RESULTS: Six trials, representing 355 people, were included in this review. Most trials reported positive findings (the absolute improvement in measured outcomes ranged from 0 to 44%), but were methodologically flawed to some extent. A 'quality of life' outcome was reported by two trials. None of the trials performed an intention-to-treat analysis and only two performed a comparison of effects between groups. Pooling of the data was not performed; because of heterogeneity of the studies, multiple outcome measurements, and the overall data presentation was too scarce. REVIEWER'S CONCLUSIONS: One cannot ignore the positive findings reported in most trials. However the scientific evidence is insufficient because of the poor methodological quality, the absence of an adequate statistical analysis, and the absence, for the patient, of most essential outcome measures (pain, self assessed function, quality of life). Therefore, the noted "positive findings" should be viewed with caution. Because of the methodological flaws an answer about the apparent effectiveness of balneotherapy cannot be provided at this moment. A large, methodological sound trial is needed.

Conservative treatment for repetitive strain injury.

Various conservative treatment options for repetitive strain injury are widely used, despite questionable evidence of their effectiveness. This systematic review evaluates the effectiveness of these treatment options for relieving symptoms of repetitive strain injury and improving activities of daily living. Searches in Medline and Embase, with additional reference checking resulted in 15 eligible trials for this review. Methodological quality was assessed, and data-extraction was performed. With the use of a "best-evidence synthesis", no strong evidence was found for the effectiveness of any of the treatment options. There is limited evidence that multidisciplinary rehabilitation, ergonomic intervention measures, exercises, and spinal manipulation combined with soft tissue therapy are effective in providing symptom relief or improving activities of daily living. There is conflicting evidence for the effectiveness of behavioral therapy. In conclusion, little is known about the effectiveness of conservative treatment options for repetitive strain injury. To establish strong evidence, more high-quality trials are needed.

Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial.

BACKGROUND: A randomized trial was performed to assess the effect of spinal cord stimulation (SCS) on detection and pain thresholds for pressure, warmth, and cold and on the extent of mechanical hyperalgesia in patients with chronic complex regional pain syndrome type I. METHODS: Fifty-four chronic complex regional pain syndrome type I patients were randomized to receive both SCS and physical therapy (SCS+PT; n = 36), or to receive only physical therapy (PT; n = 18). Twenty-four SCS+PT patients responded positively to trial stimulation and underwent SCS implantation. During a 12-month follow-up period, six quantitative sensory testing sessions were performed. The main analysis compared 24 SCS patients with 29 nonimplanted patients--one PT patient was excluded. RESULTS: SCS showed no effect on detection thresholds for warmth and cold or on pain thresholds for any sensation. The pressure detection threshold initially increased by SCS, but after 3 months, pressure detection thresholds returned to normal. Mechanical hyperalgesia, both dynamic and static, was reduced slightly with SCS. CONCLUSIONS: Although SCS has previously been shown to cause a significant pain reduction in complex regional pain syndrome type I, the treatment has no long-term effect on detection and pain thresholds for pressure, warmth, or cold. The treatment seems to have only minimal influence on mechanical hyperalgesia.

Which patients with chronic reflex sympathetic dystrophy are most likely to benefit from physical therapy?

BACKGROUND: Chronic reflex sympathetic dystrophy (RSD) is a painful and disabling disorder for which no treatment with proven effects exists. Physical therapy (PT) has been demonstrated to be effective for recently diagnosed RSD, but its value in chronic RSD has not yet been studied. OBJECTIVE: To find predictors for successful use of PT in RSD with regard to (1) function, strength, and mobility and (2) patient satisfaction. SUBJECTS: Fifty-four patients with chronic RSD, age range 21 to 65 years. METHODS: All patients were treated in accordance with a standardized PT protocol for at least 6 months. The effects of treatment (functional status, strength, range of motion) and patient satisfaction measures (grade for result, would repeat, global effect) were evaluated at 12 months. Subgroup analyses were performed to find predictors for success of PT. RESULTS: The subgroup analyses revealed that patients with better baseline function (especially of the hands) obtained better results and greater satisfaction. Greater satisfaction was also associated with less baseline pain and higher baseline range of motion and strength (of leg) values. In general, PT did not show large improvements on effect measures, and the patients' mean grade for the result was 3.8 (on a 10-point scale). CONCLUSIONS: In overall terms, PT did not influence functional parameters or give satisfaction to patients with chronic RSD in this study. A randomized trial is required to prove or exclude the actual value of PT for these patients.

Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy.

BACKGROUND: Chronic reflex sympathetic dystrophy (also called the complex regional pain syndrome) is a painful, disabling disorder for which there is no proven treatment. In observational studies, spinal cord stimulation has reduced the pain associated with the disorder. METHODS: We performed a randomized trial involving patients who had had reflex sympathetic dystrophy for at least six months. Thirty-six patients were assigned to receive treatment with spinal cord stimulation plus physical therapy, and 18 were assigned to receive physical therapy alone. The spinal cord stimulator was implanted only if a test stimulation was successful. We assessed the intensity of pain (on a visual-analogue scale from 0 cm [no pain] to 10 cm [very severe pain]), the global perceived effect (on a scale from 1 [worst ever] to 7 [best ever]), functional status, and the health-related quality of life. RESULTS: The test stimulation of the spinal cord was successful in 24 patients; the other 12 patients did not receive implanted stimulators. In an intention-to-treat analysis, the group assigned to receive spinal cord stimulation plus physical therapy had a mean reduction of 2.4 cm in the intensity of pain at six months, as compared with an increase of 0.2 cm in the group assigned to receive physical therapy alone (P<0.001 for the comparison between the two groups). In addition, the proportion of patients with a score of 6 ("much improved") for the global perceived effect was much higher in the spinal cord stimulation group than in the control group (39 percent vs. 6 percent, P=0.01). There was no clinically important improvement in functional status. The health-related quality of life improved only in the 24 patients who actually underwent implantation of a spinal cord stimulator. Six of the 24 patients had complications that required additional procedures, including removal of the device in 1 patient. CONCLUSIONS: In carefully selected patients with chronic reflex sympathetic dystrophy, electrical stimulation of the spinal cord can reduce pain and improve the health-related quality of life.

Behavioral-graded activity compared with usual care after first-time disk surgery: considerations of the design of a randomized clinical trial.

OBJECTIVE: To present the design of a trial on the effectiveness of a behavioral-graded activity model. DESIGN: Randomized clinical trial. PATIENTS: Patients undergoing first-time lumbar disk surgery who still have low-back pain at the 6-week neurosurgical consultation. INTERVENTIONS: A patient-tailored behavioral-graded activity program that is based on operant therapy. The key elements of this program are baseline measurements, goal-setting, and time-contingency. This program is compared with usual care in physiotherapy, which is pain-contingent. OUTCOME MEASURES: Primary measures are the patient's global impression of the effect and their functional status. Secondary measures are kinesiophobia, catastrophizing, pain, main complaint, range of motion, and relapses. The direct and indirect costs will also be assessed. The effect measures are rated before randomization and 3, 6, and 12 months later. DISCUSSION: Several trials have been conducted on the effectiveness of behavioral treatments. Subjects were always patients with chronic low-back pain. In this trial, we apply such a treatment in patients after first-time disk surgery in a primary care setting.

Balneotherapy for rheumatoid arthritis and osteoarthritis.

BACKGROUND: Balneotherapy (hydrotherapy or spa therapy) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain and as a consequence to relieve patients' suffering and make them feel well. OBJECTIVES: To perform a systematic review to assess the effects of balneotherapy for rheumatoid arthritis and osteoarthritis. SEARCH STRATEGY: Using the Cochrane search strategy, studies were found by screening: 1) The Medline CD-ROM database from 1966 to June 1999 and 2) the database from the Cochrane Field 'Rehabilitation and Related Therapies', which contains also studies published in journals not covered by Medline. Also, 3) reference checking and 4) personal communications with authors was carried out to retrieve eligible studies. To perform an adequate assessment of the methodological quality the languages of the publications had to be: Dutch, English, French or German. Date of the most recent literature search: June, 1999 SELECTION CRITERIA: Studies were eligible if they were randomized controlled trials (RCT) comparing balneotherapy with any intervention or with no intervention. Patients included had rheumatoid arthritis (RA), osteoarthritis (OA) or some other form of arthritis. Trials incorporating patients with definite or classical rheumatoid arthritis (RA) as defined by the American Rheumatism Association Criteria (ARA) (Ropes 1958) (these criteria have changed over time) or by the criteria of Steinbrocker (1949) were regarded as a separate group. At least one of the WHO/ILAR core set of endpoints for RA clinical trials had to be the main outcome measures. DATA COLLECTION AND ANALYSIS: A criteria list used to assess the methodological quality was the one developed at the Department of Epidemiology at the Maastricht University, called "the Maastricht list". The quality scores and data abstraction of the studies were carried out independently by two reviewers (HdV, RdB). Disagreements were solved by consensus. MAIN RESULTS: Ten trials with 607 patients were included in this review. Most trials reported positive findings, but were methodologically flawed to some extent. A 'quality of life' outcome was reported by two trials. Just one of the randomized trials mentioned an intention-to-treat analysis and only three performed a comparison of effects between groups. Pooling of the data was not performed, because of heterogeneity of the studies, multiple outcome measurements, and, apart from two studies, the overall data presentation was too scarce to enable pooling of the data. REVIEWER'S CONCLUSIONS: One cannot ignore the positive findings reported in most trials. However the scientific evidence is weak because of the poor methodological quality, the absence of an adequate statistical analysis, and the absence, for the patient, of most essential outcome measures (pain, quality of life), Therefore, the noted "positive findings" should be viewed with caution. Because of the methodological flaws an answer about the efficacy of balneotherapy cannot be provided at this time. Flaws found in the reviewed studies could be avoided in future trials.

A patient-specific approach for measuring functional status in low back pain.

BACKGROUND: Activities and their importance for daily living vary widely between patients. Patient-specific measurement of functional status means that the evaluation is focused on activities that an individual patient selected as main complaints. OBJECTIVE: To develop and to evaluate a patient-specific approach for measuring functional status in low back pain. STUDY DESIGN: A cohort of 150 patients was measured at baseline and 12 weeks later. METHODS: The feasibility of the patient-specific approach was evaluated in patients with nonspecific low back pain. We used effect size statistics to evaluate responsiveness in terms of sensitivity to change and specificity to change. RESULTS: The selection procedure for the main complaint was feasible but labor intensive. The patient-specific approach was able to detect changes in complaints that were highly relevant for the patients. The patient-specific approach appeared to be more sensitive to change but less specific to change compared with other instruments. CONCLUSIONS: On the basis of this study it would be valuable to apply the patient-specific approach in future studies, also with the aim of further evaluation. In the meantime a number of practical problems of the method need to be resolved.

Balneotherapy and quality assessment: interobserver reliability of the Maastricht criteria list and the need for blinded quality assessment.

This study investigates aspects of the reliability of the Maastricht criteria list for quality assessment in systematic reviews, and whether blinded reviewing is necessary to prevent review bias. We used the data set of 12 articles from a systematic review concerning the efficacy of balneotherapy in patients with arthritis. Twenty reviewers participated of which two reviewers, who have been involved in developing the Maastricht criteria list, acted as reference standard. Half of all assessments were performed blindly. A high level of agreement was found between the reviewers and a high level of correlation with the reference standard. The quality scores between the blinded and unblinded assessment did not differ much. Based on the results we conclude that the Maastricht criteria list is a reliable instrument in quality assessment of clinical trials. Within the limits of this study we found no evidence that blinding is necessary to prevent review bias.

Taking baths: the efficacy of balneotherapy in patients with arthritis. A systematic review.

OBJECTIVE: To review English, French, German, and Dutch language studies of the effectiveness of balneotherapy. Balneotherapy (hydrotherapy or spa therapy) is one of the oldest forms of therapy for patients with arthritis. One of the aims of balneotherapy is to relieve pain. METHODS: We performed a systematic review that included randomized and nonrandomized studies. Quality scores of the studies were determined using a criteria list. RESULTS: Most studies report positive findings, but all studies showed methodological flaws. A quality of life measurement was never reported as an outcome measure. None of the randomized clinical trials included intention-to-treat analysis or comparison of effects between groups. CONCLUSION: Because of the methodological flaws a conclusion about the efficacy of balneotherapy cannot be provided from studies we reviewed. We conclude that most flaws found could be avoidable in future research.