Trial record 17 of 20 for:
Open Studies | "Ankle Injuries"
Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain
This study is currently recruiting participants.
Verified November 2012 by Franklin Pierce University
Sponsor:
Franklin Pierce University
Information provided by (Responsible Party):
Joshua Cleland, DPT, OCS, Franklin Pierce University
ClinicalTrials.gov Identifier:
NCT00797368
First received: November 24, 2008
Last updated: November 29, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ankle Sprain |
Other: Manual Therapy and Exercise Other: Home exercises |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Exercise and Physical Fitness
Drug Information available for:
Sodium polystyrene sulfonate
U.S. FDA Resources
Further study details as provided by Franklin Pierce University:
Primary Outcome Measures:
- Foot and Ankle Ability Measure [ Time Frame: 4-weeks and 6-months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Numeric Pain Rating Scale [ Time Frame: 4-weeks and 6-months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 78 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Manual Therapy and Exercise
Manual Therapy and Exercise
|
Other: Manual Therapy and Exercise
Manual Therapy and Exercise
|
|
Active Comparator: Home Exercise
Home Exercise
|
Other: Home exercises
Home exercises
|
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion/Exclusion Criteria:
- 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.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797368
Contacts
| Contact: Josh Cleland, PT, PhD | 603.464.2175 | joshcleland@comcast.net |
Locations
| United States, Colorado | |
| Regis University | Recruiting |
| Denver, Colorado, United States, 80221 | |
| Contact: Mike Keirns, PT, PhD 303-458-4982 mkeirns@regis.edu | |
| Colorado University | Recruiting |
| Denver, Colorado, United States, 80221 | |
| Contact: Paul Mintken, PT paul.mintken@ucdenver.edu | |
| United States, New Hampshire | |
| Concord Hospital | Recruiting |
| Concord, New Hampshire, United States, 03301 | |
| Contact: Melanie Bieniek, PT 603-227-7000 mbieniek@crhc.org | |
Sponsors and Collaborators
Franklin Pierce University
More Information
No publications provided
| Responsible Party: | Joshua Cleland, DPT, OCS, Professor, Franklin Pierce University |
| ClinicalTrials.gov Identifier: | NCT00797368 History of Changes |
| Other Study ID Numbers: | HIC0828 |
| Study First Received: | November 24, 2008 |
| Last Updated: | November 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Franklin Pierce University:
|
ankle sprain manual therapy exercise physical therapy Patients who have sustained an inversion ankle sprain |
Additional relevant MeSH terms:
|
Sprains and Strains Ankle Injuries Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 22, 2013