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

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ClinicalTrials.gov Identifier: NCT02252276
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Daniel Pecos Martín, University of Alcala

Tracking Information
First Submitted Date  ICMJE September 23, 2014
First Posted Date  ICMJE September 30, 2014
Last Update Posted Date September 30, 2014
Study Start Date  ICMJE January 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • The Cumberland Ankle Instability Tool (CAIT) [ Time Frame: 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Manual Therapy and Exercise in the Treatment of Ankle Sprains
Official Title  ICMJE Effects of Manual Therapy and Exercise in the Treatment of Recurrent Ankle Sprains: Randomised Trial
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankle Sprains
Intervention  ICMJE
  • Procedure: Experimental (proprioception exercises, muscle strengthening, joint mobilization)
    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
  • Procedure: Control (proprioception exercises, muscle strengthening)
    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
Study Arms  ICMJE
  • Experimental: Experimental
    performed the same exercises and manual therapy during 4 weeks
    Intervention: Procedure: Experimental (proprioception exercises, muscle strengthening, joint mobilization)
  • Active Comparator: Control
    performed proprioceptive and strengthening exercises during 4 weeks
    Intervention: Procedure: Control (proprioception exercises, muscle strengthening)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2014)
54
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02252276
Other Study ID Numbers  ICMJE M2013/031/20131120
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Daniel Pecos Martín, University of Alcala
Study Sponsor  ICMJE University of Alcala
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tomas Gallego-Izquierdo, Dr Alcala University
PRS Account University of Alcala
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP