title: Manual and manipulative therapy in addition to rehabilitation for osteoarthritis of the knee: assessor-blind randomized pilot trial.
abstract: OBJECTIVE
  The purpose of this study was to examine the methodological integrity, sample size requirements, and short-term preliminary clinical outcomes of manual and manipulative therapy (MMT) in addition to a rehabilitation program for symptomatic knee osteoarthritis (OA).
  
  
  METHODS
  This was a pilot study of an assessor-blinded, randomized, parallel-group trial in 2 independent university-based outpatient clinics. Participants with knee OA were randomized to 3 groups: 6 MMT sessions alone, training in rehabilitation followed by a home rehabilitation program alone, or MMT plus the same rehabilitation program, respectively. Six MMT treatment sessions (provided by a chiropractic intern under supervision or by an experienced chiropractor) were provided to participants over the 4-week treatment period. The primary outcome was a description of the research methodology and sample size estimation for a confirmatory study. The secondary outcome was the short-term preliminary clinical outcomes. Data were collected at baseline and 5weeks using the Western Ontario and McMasters Osteoarthritis Index questionnaire, goniometry for knee flexion/extension, and the McMaster Overall Therapy Effectiveness inventory. Analysis of variance was used to compare differences between groups.
  
  
  RESULTS
  Eighty-three patients were randomly allocated to 1 of the 3 groups (27, 28, and 28, respectively). Despite 5 dropouts, the data from 78 participants were available for analysis with 10% of scores missing. A minimum of 462 patients is required for a confirmatory 3-arm trial including the respective interventions, accounting for cluster effects and a 20% dropout rate. Statistically significant and clinically meaningful changes in scores from baseline to week 5 were found for all groups for the Western Ontario and McMasters Osteoarthritis Index (P ≤ .008), with a greater change in scores for MMT and MMT plus rehabilitation. Between-group comparison did not reveal statistically significant differences between group scores at week 5 for any of the outcome measures (P ≥ .46).
  
  
  CONCLUSIONS
  This pilot trial suggests that a confirmatory trial is feasible. There were significant changes in scores from baseline to week 5 across all groups, suggesting that all 3 treatment approaches may be of benefit to patients with mild-to-moderate knee OA, justifying a confirmatory trial to compare these interventions.
authors.affiliation: Private Practice, Department of Chiropractic, Durban University of Technology, Durban, South Africa.
authors.forename: Lauren
authors.initials: L
authors.lastname: Dwyer
authors.affiliation: Adjunct Senior Lecturer, Murdoch University, Murdoch, Australia.
authors.forename: Gregory F
authors.initials: GF
authors.lastname: Parkin-Smith
authors.affiliation: Adjunct Associate Professor, School of Chiropractic and Sports Science, Murdoch University, Murdoch, Australia. Electronic address: Jimbrant2002@yahoo.com.
authors.forename: James W
authors.initials: JW
authors.lastname: Brantingham
authors.affiliation: Senior Lecturer in Chiropractic, Department of Chiropractic, Durban University of Technology, Durban, South Africa.
authors.forename: Charmaine
authors.initials: C
authors.lastname: Korporaal
authors.affiliation: Practicing Chiropractor, Erie, PA.
authors.forename: Tammy K
authors.initials: TK
authors.lastname: Cassa
authors.affiliation: Director, Global Health Economics, Amgen Inc, Thousand Oaks, CA.
authors.forename: Gary
authors.initials: G
authors.lastname: Globe
authors.affiliation: Associate Professor, Texas Chiropractic College, Pasadena, TX.
authors.forename: Debra
authors.initials: D
authors.lastname: Bonnefin
authors.affiliation: Radiologist, Rowland Heights, CA.
authors.forename: Victor
authors.initials: V
authors.lastname: Tong
mesh_terms: D000368:Aged; D003131:Combined Modality Therapy; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D026201:Musculoskeletal Manipulations; D020370:Osteoarthritis, Knee / Q000628:therapy*; D010147:Pain Measurement; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D010865:Pilot Projects; D016037:Single-Blind Method
keywords: Knee; Musculoskeletal Manipulations; Osteoarthritis; Pilot Projects; Rehabilitation