NCT05561959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

September 19, 2022

Last Update Submit

September 27, 2023

Conditions

Keywords

Achilles tendinopathyphonophoresistopical glyceryl trinitrate

Outcome Measures

Primary Outcomes (3)

  • the change in thickness of Achilles tendon

    measured by Ultrasonography.

    at first week and after 12 week of treatment

  • the change in Pain in patients with non-insertional Achilles tendinopathy.

    measured by Visual Analog Scale

    at first week and after 12 week of treatment

  • the change in Functional performance

    measured by vertical countermovement jump test.

    at first week and after 12 week of treatment

Study Arms (2)

Phonophoresis Group

EXPERIMENTAL

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

Other: topical glyceryl trinitrate gel

Eccentric exercises Group

ACTIVE COMPARATOR

eccentric exercises three times a week for four weeks

Other: Eccentric exercises

Interventions

topical nitroglycerin medication were treated with 1 gr nitroglycerin 2% gel

Phonophoresis Group

stretching exercises of the gastrocnemius (straight leg) and soleus (bended knee).

Eccentric exercises Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Cairo university

Giza, 338772, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy Basic Science department faculty of physical therapy

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 30, 2022

Study Start

November 1, 2022

Primary Completion

February 1, 2023

Study Completion

April 1, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations