Summary of findings
In summary the results showed that patients who received naprapathy had larger improvements in pain, physical function, quality of life, and less healthcare visits compared with the control group, thus, the results are consistent with those from the 12-months follow-up of the original study7. The control group’s physical function was more or less unchanged for the whole follow-up period of 8 years, and the improvement in bodily pain was smaller in the control group compared with the experimental group. Meanwhile, the total number of health care visits was significantly larger in the control group. Physiotherapy is usually a part of standard care for non-surgical orthopaedic outpatients both in primary and secondary, specialized health care, and it was by far the most common intervention in the control group at the 12-months as well as at the 96-months follow-up. The physiotherapy employed in the present study was general physiotherapy (i.e. rehabilitation through physical exercises)22. To the best of our knowledge this is the first trial on the effects of a manual therapy compared with standard orthopaedic care for the most common disorders in low priority non-surgical outpatients in specialized care, with longer follow-up than 12 months, and therefore there are no related articles in the published literature for direct comparison with our study.
Strengths and weaknesses/methodological considerations
Strengths of our study include the research question, the study design, with “real world data” from a clinical setting, a high response rate even at the 8-year follow up (i.e. 96%), and the fact that all outcomes were significantly better in the experimental group. The location of the disorders, age and gender closely mirrored orthopaedic waiting lists in general, which strengthens the study’s external validity. The outcomes in pain, physical function and health care utilization were also consistent with those between baseline, 3, 6 and 12 months in the original study, in terms of differences between the groups, except that the differences between the groups were larger between 12 and 96 months compared with earlier follow-ups, for all outcomes. This is in contrast to earlier trials on other manual therapy or physiotherapy for musculoskeletal disorders, where follow-ups were only made until 12 months, and the initial differences in effects by then had lost statistical significance15,23,24. Pain, physical function and QoLs were derived from validated instruments (the SF36 and SF6D, respectively) and information about the participants’ health care utilization comprising both alternative care and traditional care within the national health care system were included, all of which we consider as strengths. During the first 12 months follow-up in the original trial the number of alternative treatments was low, and equally distributed in both groups, which suggests that it did not contribute to bias with regard to the outcomes of the original study and increases the study’s internal validity. At follow-up after 96 months the number of alternative treatments increased, why a sensitivity analysis regarding those treatments was performed, which is also a strength. The study also has weaknesses that need to be taken into account. The initial power calculation suggested a sample size of 80 participants, and at the 8-year follow-up the number of participants was n = 75 (i.e. 96%), which may have resulted in an underpowered study. However, given the long follow-up period, and the fact that the outcomes were consistent, it is unlikely that a loss of only 5 participants would have changed the conclusions of our study. The fact that the manual therapy in the experimental group was performed in the shape of naprapathy may be seen as a weakness when considering the generalizability of the results, but the manual techniques used by naprapaths are very similar to those given by other manual therapists such as chiropractors and osteopaths, which makes it possible to generalize the results. Another weakness is that no follow-ups were made between 12 and 96 months (8 years). It would have been interesting to know more about the participants’ health status during the study period, though this was not possible due to reasons of feasibility and lack of resources. Nevertheless, the outcomes were consistent and clinically relevant at all follow-ups, why it is not sure that more frequent follow-ups would have had an impact on the conclusions of our study. More frequent follow-up periods might provide different and more detailed perspectives of clinical and cost related consequences over time though, which should be considered in future studies. The information about health care utilization was collected retrospectively, which may also be considered a weakness, but in order to minimize the risk of recall bias and misunderstandings regarding health care utilization and alternative treatments, data were recorded over telephone and cross checked in the hospital’s information system. A large amount of alternative treatments were used by a few participants in the control group between 12 and 96 months, which may be considered a weakness, though sensitivity analyses showed that even after excluding all alternative treatments from the analyses there were still statistically significant differences between the groups as regards health care utilization. More surgical interventions were made in the experimental group (n = 5) between 12 and 96 months, compared with the control group (n = 2). However, this was due to the fact that 3 of the surgical interventions in the experimental group had been postponed from the original trial (i.e. participants assessed as surgical cases chose not to have surgery at that time) and, moreover, the total number of surgical interventions for the whole follow-up period from baseline to 8 years was higher in the control group (i.e. n = 9) compared with the experimental group (n = 6).
Earlier research has shown that combining one or more treatment techniques with home exercises, like within the pragmatic approach used in naprapathy has proved to be effective25 and the results of our study are in line with earlier performed research on naprapathy and chiropractic for neck and back pain, and other musculoskeletal disorders, with 12 months follow-up14,26−29. A part from the effectiveness of combining different treatment techniques another possible explanation for the larger improvement in the experimental therapy group in the present study may be the patient centered care and patient empowerment approach30 used in naprapathy, in which the participants are active during the treatment sessions and after, through individualized home exercises31. This may be the reason why the experimental group kept improving, in particular in physical function. A typical manual therapy treatment session is longer than that of an orthopedic consultation (i.e. 30–45 minutes, as compared to 10–20 minutes), which possibly allows for the patient to reflect and to ask all necessary questions. The exercises given in the experimental group were patient centered; pragmatic and adjusted to the patients’ individual needs during the treatment period, and it is plausible that this contributed to patient empowerment and positive copying strategies, believed to have an impact on treatment outcomes30. There are a lot of shorter educations in different general manual therapies, and there are professions specialized in manual therapy, for example naprapaths, chiropractors, osteopaths, and physiotherapists with an extended education in Orthopedic Manual Therapy (OMT), and in Sweden and Scandinavia all of these professions - except osteopathy - are licensed by the National Board of Health and Welfare. There are similarities between specialized manual therapy (naprapaths, chiropractors, osteopaths and OMT physiotherapists) and general physiotherapy, and there are also key differences as regards the lengths and contents of the different educations22,32. Just like in for example Canada, Australia, and the Netherlands, an additional post graduate training is required for physiotherapists in order to be specialized in manual therapy (i.e. OMT), that is, educated in different mobilization techniques and high velocity, low amplitude manipulations. Approximately 2% of all licensed physiotherapists in Sweden have this specialization33.
Earlier studies on orthopaedic outpatients have investigated the role of physiotherapy in order to reduce waiting lists and found that extended scope physiotherapists are effective in triaging patients on the waiting lists for orthopaedic consultation19–21. The focus of these studies were on a physiotherapeutic assessment of patients, not the effectiveness of physiotherapy per se, and only one of these studies had a randomized controlled design34. That study showed differences in favor of the physiotherapy decisions in terms of HRQoL, pain-related disability and sick leave at 3 months but lost statistical significance at 12 months24. The aim of the present study was to compare a specialized manual therapy with standard orthopaedic care, though standard care for low priority orthopaedic outpatients with non-surgical musculoskeletal disorders most often consists of general physiotherapy, which was the far most common intervention in the control group. The participants in that group received a large number of physiotherapy sessions until the 12-months follow-up (altogether 242 sessions for 1/3 of the control group compared with 166 naprapathic sessions for the whole manual therapy group), still, the experimental group improved more, and at lower costs10.
General physiotherapists work with “hands-off treatment” aimed to prevent, treat and rehabilitate musculoskeletal pain and disability mainly through patient movements, advices on ergonomics, and physical exercises22,35. Specialized manual therapists work to prevent, diagnose and treat musculoskeletal pain and disability using “hands-on treatment” such as massage and different mobilization and/or manipulation techniques, combined with physical home exercises36.
Resource utilization is applied when taking care of musculoskeletal pain and disorders in national health care systems, and for the sample of secondary health care patients in the present study that was a less effective way to manage their disorders compared with the complementary therapy naprapathy. Large high quality trials on the cost effectiveness of specialized manual therapy for all kinds of musculoskeletal disorders and follow-ups of more than 12 months are warranted, in order for policy makers to facilitate adequate evidence-based decisions regarding appropriate triaging of patients with musculoskeletal disorders37.