Ankle SprainNCT00797368
Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain
A study testing Manual Therapy and Exercise and Home exercises in people with Ankle Sprain, run by Franklin Pierce University at 3 sites in United States.
Trial summary
A recent study has demonstrated that a physical therapist directed exercise program did not result in greater reductions in disability and pain when compared to a home exercise program. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Manual Therapy and Exercise and Home exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2008to Jun 2012
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A combination of physical examination and self-report measures will be used to assess the patient's potential eligibility according to each inclusion/exclusion criterion.
- The following inclusion criteria will be used to determine eligibility for this study:
- Primary complaint of ankle pain, status post inversion ankle sprain.
- The investigators decided to include patients with both acute and chronic ankle sprains since our previous work has shown that patients from both stage have exhibited positive benefits with manual therapy.66
- Age between 16-60 years old
- NPRS score > 3 points (average score) over past 24 hrs.
Show all 13Show fewer
- Does not meet criteria for needing radiographs per the Ottawa Ankle Rules
- The following exclusion criteria will be used to determine ineligibility for this study:
- Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, RA, osteoporosis, prolonged history of steroid use, severe vascular disease, etc.)
- Prior surgery to the distal tibia, fibula, ankle joint, or rearfoot region (proximal to the base of the metatarsals).
- Grade III ankle sprain (as defined by the West Point Ankle Sprain Grading System and/or tenderness along the anterior medial malleolus as described by,51 fracture, or other absolute contraindications to manual therapy.
- Insufficient English language skills to complete all questionnaires
- Inability to comply with treatment and follow-up schedule
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Concord Hospital
Concord, New Hampshire, 03301
Colorado University
Denver, Colorado, 80221
Regis University
Denver, Colorado, 80221
About this study
Official title: Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial
A recent study has demonstrated that a physical therapist directed exercise program did not result in greater reductions in disability and pain when compared to a home exercise program. However, no manual therapy procedures were incorporated into the physical therapy treatment program despite recent evidence suggesting that thrust and non-thrust manual therapy techniques may be beneficial in reducing disability, pain and improving gait. Therefore, the purpose of this study is to compare the effectiveness of a physical therapy management approach consisting of manual therapy and exercise to a home program of exercise only. The investigators hypothesize that the group receiving manual therapy and exercise will have better outcomes.
- Conditions
- Ankle Sprain
- Being tested
- Manual Therapy and Exercise, Home exercises
- Keywords
- ankle sprain, manual therapy, exercise, physical therapy, Patients who have sustained an inversion 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.
Manual Therapy and ExerciseOther
Manual Therapy and Exercise
Home exercisesOther
Home exercises
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy and Exercise | Experimental | Manual Therapy and Exercise Receives: Other: Manual Therapy and Exercise |
| Home Exercise | Active comparator | Home Exercise Receives: Other: Home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Ability Measure
Measured: 4-weeks and 6-months
Secondary outcomes (1)
Numeric Pain Rating Scale
Measured: 4-weeks and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainStudies 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
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franklin Pierce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Cleland, DPT, OCS, Franklin Pierce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797368
- Sponsor's protocol ID
- HIC0828
- Status last verified
- Jul 2013
- First submitted
- 24 Nov 2008
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cleland JA, Mintken PE, McDevitt A, Bieniek ML, Carpenter KJ, Kulp K, Whitman JM. Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2013;43(7):443-55. doi: 10.2519/jospt.2013.4792. Epub 2013 Apr 29.
PubMed 23628755
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00797368
- Acronym / sponsor ID
- HIC0828
- Conditions
- Ankle Sprain
- Keywords
- ankle sprain, manual therapy, exercise, physical therapy, Patients who have sustained an inversion ankle sprain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Franklin Pierce UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Nov 2008 (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.
A recent study has demonstrated that a physical therapist directed exercise program did not result in greater reductions in disability and pain when compared to a home exercise program. However, no manual therapy procedures were incorporated into the physical therapy treatment program despite recent evidence suggesting that thrust and non-thrust manual therapy techniques may be beneficial in reducing disability, pain and improving gait. Therefore, the purpose of this study is to compare the effectiveness of a physical therapy management approach consisting of manual therapy and exercise to a home program of exercise only. The investigators hypothesize that the group receiving manual therapy and exercise will have better outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy and Exercise | Experimental | Other: Manual Therapy and ExerciseManual Therapy and Exercise |
| Home Exercise | Active comparator | Other: Home exercisesHome Exercise |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- A combination of physical examination and self-report measures will be used to assess the patient's potential eligibility according to each inclusion/exclusion criterion.
- The following inclusion criteria will be used to determine eligibility for this study:
- The following exclusion criteria will be used to determine ineligibility for this study:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Manual Therapy and ExerciseManual Therapy and Exercise | Other | Manual Therapy and Exercise |
| Home exercisesHome exercises | Other | Home Exercise |
Primary outcome
Foot and Ankle Ability Measure
Time frame: 4-weeks and 6-months
1 secondary outcome
Numeric Pain Rating Scale
Time frame: 4-weeks and 6-months
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 9 Jul 2013.
- Derived from this study: PubMed 23628755Cleland JA, Mintken PE, McDevitt A, Bieniek ML, Carpenter KJ, Kulp K, Whitman JM. Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2013;43(7):443-55. doi: 10.2519/jospt.2013.4792. Epub 2013 Apr 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercise and Home exercises in people with Ankle Sprain, run by Franklin Pierce University at 3 sites in United States.
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 13 inclusion and 0 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 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Foot and Ankle Ability Measure (time frame: 4-weeks and 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797368, which also lists 1 linked publication.
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 9 Jul 2013.