- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561959
Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Achilles Tendinopathy
Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Non-insertional Achilles Tendinopathy: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pain in the Achilles tendon is quite common in individuals who participate in sports It is also common, however, in nonathletic individuals, particularly in persons of middle age who are of heavier weight Treating this condition can be very challenging. It is seen most commonly in the mid-portion of the tendon. The pathologic changes that occur to an Achilles tendon under repetitive stress will initially be a disruption of collagen fibers that have been unable to adapt to the persistent demand. This results in a cascade of events that, if left unchecked, will ultimately lead to significant pain and dysfunction. Repetitive loading leads to tendon degeneration, manifested as loss of normal collagen patterns and replacement of normal tissue with disorganized arrays of collagen and proliferative extracellular matrix. The tendon becomes infiltrated with mucoid material, calcification, fibrocartilage, and lipid droplets.
Historically, one of the most well-established exercise regimens for Achilles tendinopathy is eccentric strength training. Eccentric exercise has been shown to improve tendon structure, which historically was considered a mechanism for improvement in some persons with Achilles tendinopathy.
Nitric oxide is a small-free radical generated by a family of enzymes, the nitric oxide synthases. In a series of experiments performed over the last 15 years, nitric oxide played a crucial beneficial role in restoring tendon function. Oxygen free radicals, in the correct dose, stimulated fibroblast proliferation. Nitric oxide can enhance tendon healing. Nitric oxide is 1 of the 10 smallest molecules. Its size and its high reactivity allow it to travel across nearly all biologic structures and to readily react with other atoms or molecules to effect a change.
so the aim of our study to compare between Phonophoresis with topical glyceryl trinitrate and eccentric strength training in treatment of Achilles tendinopathy
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doaa Elazb, Lecturer
- Phone Number: 01005591580
- Email: doaarafat80@gmail.com
Study Locations
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Giza, Egypt, 338772
- Faculty of Physical Therapy Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 20-50 years old
- The diagnosis was based on pain located in the Achilles tendon for at least 3 months.
- Pain in the Achilles tendon area with distinct tenderness of the tendon 2 to 6 cm above the Achilles tendon insertion on the calcaneus
- Ultrasonographic changes defined as local thickening of the symptomatic tendon, irregular tendon structure and fiber orientation, and separated tendon fibers or a globally more than 2 mm thicker tendon on the sick side
- Diffuse pain in the posterior region of the ankle with local tenderness of the Achilles tendon and ultrasonographic changes.
Exclusion Criteria:
- Symptoms of <3 months, previous surgery, previous ankle dislocation, distal neurology, steroid injections in last 3 month, pregnancy, and contraindication to GTN
- Treatment of achillodynia with stretching or eccentric training for more than 2 weeks within the last 2 years
- Other injuries in the lower extremity or the knee, which by the examining doctor was evaluated to influence the evaluation of symptoms or the ability to perform the training program
- Acute symptoms with ultrasonographic changes consistent with a partial rupture of the tendon
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phonophoresis Group
Phonophoresis with topical glyceryl trinitrate traditional therapy three times a week for four week
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topical nitroglycerin medication were treated with 1 gr nitroglycerin 2% gel
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Active Comparator: Eccentric exercises Group
eccentric exercises three times a week for four weeks
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stretching exercises of the gastrocnemius (straight leg) and soleus (bended knee).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the change in thickness of Achilles tendon
Time Frame: at first week and after 12 week of treatment
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measured by Ultrasonography.
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at first week and after 12 week of treatment
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the change in Pain in patients with non-insertional Achilles tendinopathy.
Time Frame: at first week and after 12 week of treatment
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measured by Visual Analog Scale
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at first week and after 12 week of treatment
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the change in Functional performance
Time Frame: at first week and after 12 week of treatment
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measured by vertical countermovement jump test.
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at first week and after 12 week of treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Insertional Achilles Tendinopathy
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University of CalgarySport Science Association of Alberta (SSAA)UnknownAchilles Tendinopathy | Achilles Tendon Enthesopathy | Mid-Portion Achilles Tendinopathy | Insertional Achilles Tendinopathy | Non-Insertional Achilles TendinopathyCanada
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Krankenhaus Barmherzige Schwestern LinzActive, not recruitingAchilles Tendinopathy | Insertional Achilles TendinopathyAustria
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Guna S.p.aRecruitingTendinopathy | Achilles Tendinopathy | Insertional Achilles Tendinopathy | PeritendinitisItaly
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Indiana University Health Ball Memorial Hospital...Performance Dynamics IncCompletedInsertional Achilles TendinopathyUnited States
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University Hospital, GhentActive, not recruitingInsertional Achilles TendinopathyBelgium
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University of DelawareRecruitingSever's Disease | Achilles Tendinopathy | Insertional Achilles Tendinopathy | Apophysitis; CalcaneusUnited States
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Assiut UniversityNot yet recruitingInsertional Achilles Tendinopathy
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Zimmer BiometEmbody Inc.Suspended
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Mike O'Callaghan Military HospitalCompletedInsertional Achilles TendinopathyUnited States
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Fortius ClinicUnknownNon-Insertional Achilles Tendinopathy | Plantaris Friction SyndromeUnited Kingdom
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