Effects of Manual Therapy and Exercise in the Treatment of Ankle Sprains

September 29, 2014 updated by: Prof. Dr. Daniel Pecos Martín, University of Alcala

Effects of Manual Therapy and Exercise in the Treatment of Recurrent Ankle Sprains: Randomised Trial

Objectives: To analyze the effects of proprioceptive and strengthening exercises versus the same exercises and manual therapy on the recurrent ankle sprain management.

Design: A randomized clinical trial with two intervention groups and triple blind.

Settings: University Hospital.

Participants: Fifty-four patients with previous history of recurrent ankle sprains, regular sports practice and pain during the physical activity, randomly assigned to experimental or control group.

Intervention: Control group performed 4 weeks of proprioceptive and strengthening exercises; experimental group performed 4 weeks of the same exercises combined with manual therapy.

Main Outcomes Measures: Pain, ankle instability, pressure pain threshold (PPT), ankle eversion strength, and active range of motion in ankle joint. The measures were taken before, after and one month after the interventions.

Study Overview

Detailed Description

The recurrent ankle sprain means the most frequent complication from the ankle sprain and the previous phase of the chronic ankle stability (CAI), which involves between 20 - 41% of all ankle sprains.

Residual pain concerns the first symptom after instability in most of the cases, but patients also show reduced ankle joint position sense, ankle range of motion, and strength of ankle inversion muscles.

Proprioception exercises on multiplane and unstable platforms, as well as strengthening through eccentric exercises report benefits in pain and function, suggesting the active therapy as the most effective treatment instead of passive manual therapy in chronic phases.

However, several studies analyzed the effects of the manual therapy in the management of the ankle sprain recurrence: the posterior gliding of astragalus and the tibiotarsal joint coaptation improved the ankle range of motion, which was related with recurrent ankle sprain and its residual symptoms.

Despite the benefits from active and passive therapy, very few authors up to date investigated the combination of both clinical approach in the recurrent ankle sprain. Literature analyzed the effects of a combined program including exercises to the manual therapy in acute ankle sprain and concluded that the variety in the manual therapy techniques reported more pain release and improved function.

Besides, based on the effects of joint mobilization techniques, the neurodynamic mobilization could be an appropriate therapy, due to the neural distribution of fibular nerve through the ankle joint, but no studies to date to our knowledge included this technique as part of the recurrent ankle sprain management.

This study aimed to analyze the effects of proprioceptive and strengthening exercises versus the same exercises and manual therapy on the recurrent ankle sprain management.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Alcala de Henares, Madrid, Spain, 28871
        • Alcala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with previous history of recurrent ankle sprain

Exclusion Criteria:

  • Subjects with surgical treatment, previous fractures on lower limb and/or adjacent pathologies were excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
performed the same exercises and manual therapy during 4 weeks
The experimental group performed a combined protocol of proprioception (the patient doing exercises standing on an unstable plane)exercises and muscle strengthening (The patient performed eccentric exercises to work the movement inversion of ankle), and joint mobilization techniques of the ankle joint two session per week, during four weeks
Active Comparator: Control
performed proprioceptive and strengthening exercises during 4 weeks
The control group performed only proprioception exercises (the patient doing exercises standing on an unstable plane) and muscle strengthening (The patient performed eccentric exercises to work the movement inversion of ankle). Two sessión per week during four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Change from baseline at one month
All the subjects showed their pain level from 0 (no pain) to 10 (maximum pain) in a Visual Analogical Scale (VAS).
Change from baseline at one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Cumberland Ankle Instability Tool (CAIT)
Time Frame: Change from baseline at one month
Change from baseline at one month
Pressure Pain Threshold (PPT)
Time Frame: Change from baseline at one month
An algometer Wagner FPI 10-WA was used to determine the PPT in the anterior talofibular ligament, the calcaneofibular ligament, tibial malleolus, and fibular malleolus. The pressure was perpendicular hold in each structure, while patients were positioned sidelined on the unaffected side with knee and hip semiflexion
Change from baseline at one month
Active range of motion in ankle joint
Time Frame: Change from baseline at one month
A standard goniometer was employed. Patients were seated in 90º knee flexion and ankle neutral position. The goniometer fulcrum was placed over the lateral malleolus, with its proximal arm over the fibular diaphysis and distal arm over the fifth metatarsal. Patients were asked to actively perform a flexion and extension of ankle.
Change from baseline at one month
Strength in ankle flexion and extension
Time Frame: Change from baseline at one month
dynamic dynamometry with MicroFet-2 was used while patients were positioned in supine and lower limb on the therapeutic table. From this position, patients performed ankle flexion and extension. The test-retest reliability of this tool has been previously shown
Change from baseline at one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tomas Gallego-Izquierdo, Dr, Alcala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

September 30, 2014

Study Record Updates

Last Update Posted (Estimate)

September 30, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • M2013/031/20131120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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