Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial

Abstract

Background: Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM) is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition.

Methods/design: We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury.

Discussion: This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention.

Trial registration: http://www.clinicaltrials.gov identifier NCT00888498.

Figures

Figure 1

Group size vs. effect size plot given d = .4 (arrow), β ≥ .80, and α = .05 for a 2-sample t-test. Optimal sample size occurs at n = 52 per group. Adding an additional 20% to group size to account for potential drop-outs, group size for this study was estimated at n = 63.

Figure 2

Flow chart for subject screening, pre-intervention measurement, intervention, and post-intervention measurements.

Figure 3

Ankle high-velocity low-amplitude, slow velocity, and control interventions under study. With the subject in a supine position on a treatment table and the lower extremity of interest stabilized to the table with a belt (A), the treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface (B) and induce passive dorsiflexion to end range (B; open arrow). Iatrogenic force will be provided along the long axis of the tibia in the intervention groups. (B; hatched line) In the control group, the treating investigator will maintain passive dorsiflexion (B; open arrow) for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force.