Non Insertional Achilles TendinopathyNCT05561959
Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Achilles Tendinopathy
A study testing topical glyceryl trinitrate gel and Eccentric exercises in people with Non Insertional Achilles Tendinopathy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Non Insertional Achilles Tendinopathy
- What is being tested?
- topical glyceryl trinitrate gel and Eccentric exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Non Insertional Achilles Tendinopathy
- Being tested
- topical glyceryl trinitrate gel, Eccentric exercises
- Keywords
- Achilles tendinopathy, phonophoresis, topical glyceryl trinitrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical glyceryl trinitrate gelOther
topical nitroglycerin medication were treated with 1 gr nitroglycerin 2% gel
Eccentric exercisesOther
stretching exercises of the gastrocnemius (straight leg) and soleus (bended knee).
| Study group | Role | What they receive |
|---|---|---|
| Phonophoresis Group | Experimental | Phonophoresis with topical glyceryl trinitrate traditional therapy three times a week for four week Receives: Other: topical glyceryl trinitrate gel |
| Eccentric exercises Group | Active comparator | eccentric exercises three times a week for four weeks Receives: Other: Eccentric exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in thickness of Achilles tendon
measured by Ultrasonography.
Measured: 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
Measured: at first week and after 12 week of treatment
the change in Functional performance
measured by vertical countermovement jump test.
Measured: at first week and after 12 week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Nov 2022
- Primary completion1 Feb 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Insertional Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Rafat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561959
- Sponsor's protocol ID
- P.T.REC/012
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Phonophoresis With Topical Glyceryl Trinitrate in Treatment of Non-insertional Achilles Tendinopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05561959
- Acronym / sponsor ID
- P.T.REC/012
- Conditions
- Non Insertional Achilles Tendinopathy
- Keywords
- Achilles tendinopathy, phonophoresis, topical glyceryl trinitrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Phonophoresis Group | Experimental | Other: topical glyceryl trinitrate gelPhonophoresis with topical glyceryl trinitrate traditional therapy three times a week for four week |
| Eccentric exercises Group | Active comparator | Other: Eccentric exerciseseccentric exercises three times a week for four weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical glyceryl trinitrate geltopical nitroglycerin medication were treated with 1 gr nitroglycerin 2% gel | Other | Phonophoresis Group |
| Eccentric exercisesstretching exercises of the gastrocnemius (straight leg) and soleus (bended knee). | Other | Eccentric exercises Group |
Primary outcome
the change in thickness of Achilles tendon
Time frame: at first week and after 12 week of treatment
measured by Ultrasonography.
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
the change in Functional performance
Time frame: at first week and after 12 week of treatment
measured by vertical countermovement jump test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Non Insertional Achilles Tendinopathy
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Achilles Tendinopathy
Enrolling by invitation
RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical glyceryl trinitrate gel and Eccentric exercises in people with Non Insertional Achilles Tendinopathy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in thickness of Achilles tendon (time frame: at first week and after 12 week of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.