search
Back to results

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

Primary Purpose

Ankle Sprains

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental (proprioception exercises, muscle strengthening, joint mobilization)
Control (proprioception exercises, muscle strengthening)
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring Manual therapy, proprioception, exercises, ankle sprain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alcalá University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

performed the same exercises and manual therapy during 4 weeks

performed proprioceptive and strengthening exercises during 4 weeks

Outcomes

Primary Outcome Measures

Pain
All the subjects showed their pain level from 0 (no pain) to 10 (maximum pain) in a Visual Analogical Scale (VAS).

Secondary Outcome Measures

The Cumberland Ankle Instability Tool (CAIT)
Pressure Pain Threshold (PPT)
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
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
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

Full Information

First Posted
September 23, 2014
Last Updated
September 29, 2014
Sponsor
University of Alcala
search

1. Study Identification

Unique Protocol Identification Number
NCT02252276
Brief Title
Effects of Manual Therapy and Exercise in the Treatment of Ankle Sprains
Official Title
Effects of Manual Therapy and Exercise in the Treatment of Recurrent Ankle Sprains: Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains
Keywords
Manual therapy, proprioception, exercises, ankle sprain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
performed the same exercises and manual therapy during 4 weeks
Arm Title
Control
Arm Type
Active Comparator
Arm Description
performed proprioceptive and strengthening exercises during 4 weeks
Intervention Type
Procedure
Intervention Name(s)
Experimental (proprioception exercises, muscle strengthening, joint mobilization)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Control (proprioception exercises, muscle strengthening)
Intervention Description
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 Outcome Measure Information:
Title
Pain
Description
All the subjects showed their pain level from 0 (no pain) to 10 (maximum pain) in a Visual Analogical Scale (VAS).
Time Frame
Change from baseline at one month
Secondary Outcome Measure Information:
Title
The Cumberland Ankle Instability Tool (CAIT)
Time Frame
Change from baseline at one month
Title
Pressure Pain Threshold (PPT)
Description
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
Time Frame
Change from baseline at one month
Title
Active range of motion in ankle joint
Description
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.
Time Frame
Change from baseline at one month
Title
Strength in ankle flexion and extension
Description
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
Time Frame
Change from baseline at one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Gallego-Izquierdo, Dr
Organizational Affiliation
Alcala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alcalá University
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs