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

NCT02252276 | Completed DMC

• 1 other identifier: M2013/031/20131120
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprains

Keywords

Manual therapy; proprioception; exercises; ankle sprain

Outcome Measures

Primary Outcomes (1)

• Pain

  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 Outcomes (4)

• The Cumberland Ankle Instability Tool (CAIT)

  Change from baseline at one month

• Pressure Pain Threshold (PPT)

  Change from baseline at one month

• Active range of motion in ankle joint

  Change from baseline at one month

• Strength in ankle flexion and extension

  Change from baseline at one month

Study Arms (2)

Experimental

EXPERIMENTAL

performed the same exercises and manual therapy during 4 weeks

Procedure: Experimental (proprioception exercises, muscle strengthening, joint mobilization)

Control

ACTIVE COMPARATOR

performed proprioceptive and strengthening exercises during 4 weeks

Procedure: Control (proprioception exercises, muscle strengthening)

Interventions

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

Experimental

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with previous history of recurrent ankle sprain

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Alcalá University

Alcalá de Henares, Madrid, 28871, Spain

Location

MeSH Terms

Conditions

Ankle Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Behavior

Study Officials

• Tomas Gallego-Izquierdo, Dr

  Alcala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Daniel Pecos Martín

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 30, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

ES (1)