title: Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee--study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis.
  
  
  METHODS
  In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ≥40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum.
  
  
  CONCLUSIONS
  This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism.
  
  
  BACKGROUND
  NCT01225133.
authors.affiliation: Institute for Social Medicine Epidemiology and Health Economics, Charité -Universitätsmedizin Berlin, Berlin, Germany. claudia.witt@charite.de
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Witt
authors.forename: Andreas
authors.initials: A
authors.lastname: Michalsen
authors.forename: Stephanie
authors.initials: S
authors.lastname: Roll
authors.forename: Antonio
authors.initials: A
authors.lastname: Morandi
authors.forename: Shivnarain
authors.initials: S
authors.lastname: Gupta
authors.forename: Mark
authors.initials: M
authors.lastname: Rosenberg
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kronpass
authors.forename: Elmar
authors.initials: E
authors.lastname: Stapelfeldt
authors.forename: Syed
authors.initials: S
authors.lastname: Hissar
authors.forename: Matthias
authors.initials: M
authors.lastname: Müller
authors.forename: Christian
authors.initials: C
authors.lastname: Kessler
mesh_terms: D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D018771:Arthralgia / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D057186:Comparative Effectiveness Research; D004032:Diet; D019587:Dietary Supplements; D004185:Disability Evaluation; D005247:Feeding Behavior; D005260:Female; D005858:Germany; D006694:Holistic Health; D006801:Humans; D007719:Knee Joint / Q000503:physiopathology*; D008297:Male; D008405:Massage; D008515:Medicine, Ayurvedic; D008875:Middle Aged; D009752:Nutritional Status; D015207:Osteoarthritis, Hip / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010147:Pain Measurement; D017060:Patient Satisfaction; D011187:Posture; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D040242:Risk Reduction Behavior; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D015013:Yoga
chemical_list: D000700:Analgesics