Ankle SprainsNCT02252276
Effects of Manual Therapy and Exercise in the Treatment of Ankle Sprains
A study testing Experimental (proprioception exercises, muscle strengthening, joint mobilization) in people with Ankle Sprains, run by University of Alcala at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Experimental (proprioception exercises, muscle strengthening, joint mobilization)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with previous history of recurrent ankle sprain
Who cannot join
- Subjects with surgical treatment, previous fractures on lower limb and/or adjacent pathologies were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Ankle Sprains
- Being tested
- Experimental (proprioception exercises, muscle strengthening, joint mobilization), Control (proprioception exercises, muscle strengthening)
- Keywords
- Manual therapy, proprioception, exercises, ankle sprain
- Medical subject headings
- Ankle Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (proprioception exercises, muscle strengthening, joint mobilization)Procedure or surgery
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 or surgery
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 group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | performed the same exercises and manual therapy during 4 weeks Receives: Procedure: Experimental (proprioception exercises, muscle strengthening, joint mobilization) |
| Control | Active comparator | performed proprioceptive and strengthening exercises during 4 weeks Receives: Procedure: Control (proprioception exercises, muscle strengthening) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
All the subjects showed their pain level from 0 (no pain) to 10 (maximum pain) in a Visual Analogical Scale (VAS).
Measured: Change from baseline at one month
Secondary outcomes (4)
The Cumberland Ankle Instability Tool (CAIT)
Measured: Change from baseline at one month
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
Measured: Change from baseline at one month
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.
Measured: Change from baseline at one month
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
Measured: Change from baseline at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Tomas Gallego-Izquierdo, Dr, Principal investigator, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252276
- Sponsor's protocol ID
- M2013/031/20131120
- Status last verified
- Sep 2014
- First submitted
- 23 Sep 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Therapy and Exercise in the Treatment of Recurrent Ankle Sprains: Randomised Trial
- ClinicalTrials.gov ID
- NCT02252276
- Acronym / sponsor ID
- M2013/031/20131120
- Conditions
- Ankle Sprains
- Keywords
- Manual therapy, proprioception, exercises, ankle sprain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Experimental (proprioception exercises, muscle strengthening, joint mobilization)performed the same exercises and manual therapy during 4 weeks |
| Control | Active comparator | Procedure: Control (proprioception exercises, muscle strengthening)performed proprioceptive and strengthening exercises during 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with previous history of recurrent ankle sprain
Key exclusion criteria (1 listed)
- Subjects with surgical treatment, previous fractures on lower limb and/or adjacent pathologies were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Experimental |
| 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 | Procedure or surgery | Control |
Primary outcome
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).
4 secondary outcomes
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
Active range of motion in ankle joint
Time frame: Change from baseline at one month
Strength in ankle flexion and extension
Time frame: Change from baseline at one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Gallego-Izquierdo, Dr principal investigator
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental (proprioception exercises, muscle strengthening, joint mobilization) in people with Ankle Sprains, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Change from baseline at one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014; AzTrials last refreshed its copy on 26 Oct 2026.