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NCT Number: NCT02252276

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

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.

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Key information

Conditions

Ankle Sprains Ankle Injuries Behavior Leg Injuries Motor Activity Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcalá University

Alcalá de Henares, Madrid, 28871, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental (proprioception exercises, muscle strengthening, joint mobilization)

Procedure

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

Control (proprioception exercises, muscle strengthening)

Procedure

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. The Cumberland Ankle Instability Tool (CAIT)

    Time frame: Change from baseline at one month

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 30, 2014
Registry last updated
Sep 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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