Background: The increasing age of the population, especially in the western world, means that the prevalence of osteoarthritis is also increasing, with corresponding socioeconomic consequences. Although there is no curative intervention at present, in accordance with US and European guidelines, pharmacotherapeutic and non-pharmacological approaches aim at pain control and the reduction of functional restriction.It has been established that hydrotherapy for osteoarthritis of the hip or knee joint using serial cold and warm water stimulation not only improves the range of movement but also reduces pain significantly and increases quality of life over a period of up to three months. Weight reduction is important for patients with osteoarthritis of the hip or knee. In addition, conventional physiotherapy and exercise therapy have both been shown, at a high level of evidence, to be cost-effective and to have long-term benefits for pain relief, movement in the affected joint, and patient quality of life.
Methods/design: The study design consists of a prospective randomised controlled three-armed clinical trial, which will be carried out at a specialist clinic for integrative medicine, to investigate the clinical effects of hydrotherapy on osteoarthritis of the knee or hip joint, in comparison with conventional physiotherapy.One hundred and eighty patients diagnosed with osteoarthritis of hip or knee will be randomly assigned to one of three intervention groups: hydrotherapy, physiotherapy, and both physiotherapy and hydrotherapy of the affected joint. In the first group, patients will receive Kneipp hydrotherapy daily, with water applied in the form of alternate cold and warm thigh affusions (alternating cold and warm water stimulation is particularly relevant to the knee and hip regions).Patients in the second group will receive physiotherapy of the hip or knee joint three times a week. Patients in the physiotherapy-hydrotherapy combination group will receive both joint-specific physiotherapy three times a week and alternate cold and warm thigh affusions every day. Follow-up assessments will be on three levels: clinical assessment by the investigator; subjective patient assessment consisting of a patient diary, and questionnaires on admission and at the end of the treatment phase; and a final telephone assessment by the external evaluation centre. Assessments will be made at baseline, after two weeks of inpatient treatment, and finally after a further ten weeks of follow-up. The primary outcome measure will be pain intensity of the affected joint in the course of inpatient treatment, judged by the patient and the investigator. Secondary outcomes include health-related quality of life and joint-specific pain and mobility in the course of the study. Statistical analysis of the results will be on an intention-to-treat basis.
Conclusion: This study methodology has been conceived according to the standards of the CONSORT recommendations. The results will contribute to establishing hydrotherapy as a non-invasive, non-interventional, reasonably priced, therapeutic option with few side effects, in the concomitant treatment of osteoarthritis of the hip or knee.
Trial registration number: NCT 00950326.
Trial registration: ClinicalTrials.gov NCT00950326.