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

Primary Purpose

Non Insertional Achilles Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
topical glyceryl trinitrate gel
Eccentric exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Insertional Achilles Tendinopathy focused on measuring Achilles tendinopathy, phonophoresis, topical glyceryl trinitrate

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of physical therapy Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phonophoresis Group

Eccentric exercises Group

Arm Description

Phonophoresis with topical glyceryl trinitrate traditional therapy three times a week for four week

eccentric exercises three times a week for four weeks

Outcomes

Primary Outcome Measures

the change in thickness of Achilles tendon
measured by Ultrasonography.
the change in Pain in patients with non-insertional Achilles tendinopathy.
measured by Visual Analog Scale
the change in Functional performance
measured by vertical countermovement jump test.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2022
Last Updated
September 27, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05561959
Brief Title
Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Achilles Tendinopathy
Official Title
Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Non-insertional Achilles Tendinopathy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Insertional Achilles Tendinopathy
Keywords
Achilles tendinopathy, phonophoresis, topical glyceryl trinitrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phonophoresis Group
Arm Type
Experimental
Arm Description
Phonophoresis with topical glyceryl trinitrate traditional therapy three times a week for four week
Arm Title
Eccentric exercises Group
Arm Type
Active Comparator
Arm Description
eccentric exercises three times a week for four weeks
Intervention Type
Other
Intervention Name(s)
topical glyceryl trinitrate gel
Intervention Description
topical nitroglycerin medication were treated with 1 gr nitroglycerin 2% gel
Intervention Type
Other
Intervention Name(s)
Eccentric exercises
Intervention Description
stretching exercises of the gastrocnemius (straight leg) and soleus (bended knee).
Primary Outcome Measure Information:
Title
the change in thickness of Achilles tendon
Description
measured by Ultrasonography.
Time Frame
at first week and after 12 week of treatment
Title
the change in Pain in patients with non-insertional Achilles tendinopathy.
Description
measured by Visual Analog Scale
Time Frame
at first week and after 12 week of treatment
Title
the change in Functional performance
Description
measured by vertical countermovement jump test.
Time Frame
at first week and after 12 week of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of physical therapy Cairo university
City
Giza
ZIP/Postal Code
338772
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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