Manipulative therapy and rehabilitation for recurrent ankle sprain with functional instability: a short-term, assessor-blind, parallel-group randomized trial.

OBJECTIVE: The purpose of this study was to compare manipulative therapy (MT) plus rehabilitation to rehabilitation alone for recurrent ankle sprain with functional instability (RASFI) to determine short-term outcomes. METHODS: This was an assessor-blind, parallel-group randomized comparative trial. Thirty-three eligible participants with RASFI were randomly allocated to receive rehabilitation alone or chiropractic MT plus rehabilitation. All participants undertook a daily rehabilitation program over the course of the 4-week treatment period. The participants receiving MT had 6 treatments over the same treatment period. The primary outcome measures were the Foot and Ankle Disability Index and the visual analogue pain scale, with the secondary outcome measure being joint motion palpation. Data were collected at baseline and during week 5. Missing scores were replaced using a multiple imputation method. Statistical analysis of the data composed of repeated-measures analysis of variance. RESULTS: Between-group analysis demonstrated a difference in scores at the final consultation for the visual analogue scale and frequency of joint motion restrictions (P ≤ .006) but not for the Foot and Ankle Disability Index (P = .26). CONCLUSIONS: This study showed that the patients with RASFI who received chiropractic MT plus rehabilitation showed significant short-term reduction in pain and the number of joint restrictions in the short-term but not disability when compared with rehabilitation alone.

Manual and manipulative therapy in addition to rehabilitation for osteoarthritis of the knee: assessor-blind randomized pilot trial.

OBJECTIVES: 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.

Manual and manipulative therapy compared to night splint for symptomatic hallux abducto valgus: an exploratory randomised clinical trial.

CONTEXT: Hallux abducto valgus (HAV) is a frequent cause of great toe pain and disability, yet common treatments are only supported by mixed or equivocal research findings. Surgery often only provides modest improvement and post-surgery complications may significantly hamper outcomes, implying the need for trials testing conservative treatment, such as manual and manipulative therapy, particularly in cases where surgery may be contraindicated or premature. The purpose of this exploratory trial was to test an innovative protocol of manual and manipulative therapy (MMT) and compare it to standard care of a night splint(s) for symptomatic mild to moderate HAV, with a view gather insight into the effectiveness of MMT and inform the design of a definitive trial. DESIGN: Parallel-group randomised trial set in an out-patient teaching clinic. PARTICIPANTS: A convenience sample of 75 patients was assessed for eligibility, with 30 participants (15 per group) being consented and randomly allocated to either the control group (standard care with a night splint) or the experimental group (MMT). INTERVENTION: Participants in the control group used a night splint(s) and those in the experimental group (MMT) received a structured protocol of MMT, with the participants in the experimental group receiving 4 treatments over a 2-week period. OUTCOME MEASURES: Visual analogue scale (HAV-related pain), foot function index (HAV-related disability) and hallux dorsiflexion (goniometry). RESULTS: There were no participant dropouts and no data was missing. There were no statistical (p<0.05) or clinically meaningful differences (MCID<20%) between the two groups based on outcome measure scores. However, the outcome measure scores in the control group (night splint) regressed between the 1-week follow-up and 1-month follow-up, while the scores in the experimental group (MMT) were sustained up to the 1-month follow-up. The within-group data analysis produced statistically and clinically significant changes from baseline to the 1-week flow-up across all outcome measures. Post hoc power analysis and sample size calculations suggest that the average between group power of this trial was approximately 60% (ES = 0.33) and that a definitive trial would require a minimum of 102 participants per group (N = 204) to achieve satisfactory power of ≥80%. CONCLUSIONS: The trend in results of this trial suggest that an innovative structured protocol of manual and manipulative therapy (experimental group) is equivalent to standard care of a night splint(s) (control group) for symptomatic mild to moderate HAV in the short term. The protocol of MMT maintains its treatment effect from 1-week to 1-month follow-up without further treatment, while patients receiving standard care seem to regress when not using the night splint. Insights from this study support further testing of MMT for symptomatic mild to moderate HAV, particularly where surgery is premature or where surgical outcomes may be equivocal, and serve to inform the design of a future definitive trial.

A feasibility study comparing two chiropractic protocols in the treatment of patellofemoral pain syndrome.

OBJECTIVE: The purpose of this pilot study was to determine the feasibility of (1) using the existing clinic, clinicians, interns, faculty, and staff from our college in conducting all components of a planned randomized controlled clinical trial; (2) successfully recruiting patients with patellofemoral pain syndrome (PFPS); and (3) consistently, effectively, and safely implementing the study protocols and therapy. METHODS: Diagnostic, treatment, and blind assessment procedures were carried out while recruitment and administrative techniques for managing long-term storage of data and files were developed. Thirty-one patients were randomized into a local manipulative group (group A) or to a full kinetic chain manipulative therapy group (group B), each combined with exercise and soft tissue treatment. The Anterior Knee Pain Scale, visual analog scale, and Patient Satisfaction Scale were used. RESULTS: All phases of the feasibility study including use of the clinic, staff, recruitment techniques, treatment protocols, data collection, input, and analysis were effectively and safely carried out. CONCLUSIONS: A feasibility study investigating the ability to conduct a randomized controlled trial of a manipulative therapy protocol for PFPS using available chiropractic college infrastructure was accomplished. A fully powered PFPS trial is feasible and merited.