Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Achilles Tendinopathy

September 27, 2023 updated by: Doaa Rafat, Cairo University

Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Non-insertional Achilles Tendinopathy: a Randomized Controlled Trial

The aim of study is to investigate the effect of Phonophoresis with topical glyceryl trinitrate versus traditional treatment in in patients with non-insertional Achilles tendinopathy.

Study Overview

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

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Giza, Egypt, 338772
        • Faculty of Physical Therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 20-50 years old
  2. The diagnosis was based on pain located in the Achilles tendon for at least 3 months.
  3. Pain in the Achilles tendon area with distinct tenderness of the tendon 2 to 6 cm above the Achilles tendon insertion on the calcaneus
  4. 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
  5. Diffuse pain in the posterior region of the ankle with local tenderness of the Achilles tendon and ultrasonographic changes.

Exclusion Criteria:

  1. Symptoms of <3 months, previous surgery, previous ankle dislocation, distal neurology, steroid injections in last 3 month, pregnancy, and contraindication to GTN
  2. Treatment of achillodynia with stretching or eccentric training for more than 2 weeks within the last 2 years
  3. 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
  4. Acute symptoms with ultrasonographic changes consistent with a partial rupture of the tendon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
topical nitroglycerin medication were treated with 1 gr nitroglycerin 2% gel
Active Comparator: Eccentric exercises Group
eccentric exercises three times a week for four weeks
stretching exercises of the gastrocnemius (straight leg) and soleus (bended knee).

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
measured by Ultrasonography.
at first week and after 12 week of treatment
the change in Pain in patients with non-insertional Achilles tendinopathy.
Time Frame: at first week and after 12 week of treatment
measured by Visual Analog Scale
at first week and after 12 week of treatment
the change in Functional performance
Time Frame: at first week and after 12 week of treatment
measured by vertical countermovement jump test.
at first week and after 12 week of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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