Achilles TendinopathyNCT04376294
Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy
A study testing Extracorporeal Shockwave Therapy(ESWT), Eccentric training of the calf muscle: and Gastrocnemius, soleus, and hamstring stretch in people with Achilles Tendinopathy, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study was to determine the effect of extracorporeal Shock wave therapy (ESWT) on functional activity and pain in patients with Achilles tendinopathy Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Extracorporeal Shockwave Therapy(ESWT), Eccentric training of the calf muscle: and Gastrocnemius, soleus, and hamstring stretch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Jun 2020
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical history of Achilles tendon pain for at least six months
- A minimum of three months conservative treatment administered without benefit for at least four weeks before ESWT.
Who cannot join
- Patients underwent physical therapy in the four weeks prior enrollment to study.
- Patients had taken non-steroidal anti-inflammatory medication during the previous week
- Patients had received peritendinous injections of a local anesthetic or corticosteroid within last 4 weeks
- Patients had bilateral Achilles tendinopathy
- Patients with other conditions that could significantly contribute to posterior ankle pain (osteoarthritis, radiculopathy, systemic neurologic conditions)
- Patients having previous injury or surgical treatments of the ankle.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine the effect of extracorporeal Shock wave therapy (ESWT) on functional activity and pain in patients with Achilles tendinopathy
Read the detailed description
Fifty patients of both sexes with Achilles tendinopathy aged 18-40 years, were assigned randomly into two equal groups. The study group received ESWT in addition to a conservative physical therapy program for four weeks, while the control group received a conservative physical therapy program only. Pain and functional mobility were assessed before and after treatment through a visual analog scale (VAS) and Victorian Institute of sports assessment - Achilles questionnaire (VISA-A), respectively
- Conditions
- Achilles Tendinopathy
- Being tested
- Extracorporeal Shockwave Therapy(ESWT), Eccentric training of the calf muscle:, Gastrocnemius, soleus, and hamstring stretch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave Therapy(ESWT)Device
Each session of Extracorporeal Shockwave Therapy(ESWT) consists of 2000 pulses with a pressure of 3 bars (equals an energy flux density of 0.1 mJ/mm²), and treatment frequency of 8 pulses/sec
Eccentric training of the calf muscle:Other
The patients were asked to stand with all their body weight on the injured leg on a wooden step. From an upright body position and standing with all body weight on the forefoot, with the ankle joint in plantar flexion. The calf muscle is loaded by having the patient lower the affected limb down by dorsiflexion the ankle until the plantar aspect of the heel lay below the level of the step, and the ankle is in maximum dorsiflexion.
Gastrocnemius, soleus, and hamstring stretchOther
Stretching every muscle for 30 seconds. Each stretch was performed 3 times (holding for 30 seconds and rest for 30 seconds). All these stretches were performed directly after the eccentric exercises twice/day for 7 days/week for weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | This group received Extracorporeal Shockwave Therapy(ESWT) + conservative Physical Therapy Treatment (eccentric training + stretching exercise) Receives: Device: Extracorporeal Shockwave Therapy(ESWT); Other: Eccentric training of the calf muscle:; Other: Gastrocnemius, soleus, and hamstring stretch |
| Control group | Active comparator | This group received conservative physical therapy treatment(eccentric training + stretching exercise) only. Receives: Other: Eccentric training of the calf muscle:; Other: Gastrocnemius, soleus, and hamstring stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A).
It consists of eight questions that covered the three domains of pain (questions 1-3), function (questions 4-6), and activity (questions 7 and 8.). Questions one to seven are scored out of 10, and question 8 carries a maximum of 30. Scores are summed to give a total out of 100.
Measured: 15 minutes
Secondary outcomes (1)
The visual analog scale (VAS).
The VAS is a continuous scale consists of a horizontal line (HVAS) usually 10 centimeters (10-100 mm) in length. For pain intensity, the scale is most anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Oct 2018
- Primary completion31 Dec 2018
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prof.Dr. Emad Samuel Boles Saweeres, Prof.Dr Nadia Abdelazim fayaz, Mr.Mohamed Nasser Kise Helmy
- Responsible party
- Principal investigator, Nasr Awad Abdelkader Othman, Cairo University
- Investigators
- Dr. Nasr A. Abdelkader, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376294
- Sponsor's protocol ID
- P.T.REC/012/002042
- Status last verified
- Jul 2020
- First submitted
- 1 May 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT04376294
- Acronym / sponsor ID
- P.T.REC/012/002042
- Conditions
- Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prof.Dr. Emad Samuel Boles Saweeres, Prof.Dr Nadia Abdelazim fayaz, Mr.Mohamed Nasser Kise Helmy
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 6 May 2020 (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 purpose of this study was to determine the effect of extracorporeal Shock wave therapy (ESWT) on functional activity and pain in patients with Achilles tendinopathy
Detailed description
Fifty patients of both sexes with Achilles tendinopathy aged 18-40 years, were assigned randomly into two equal groups. The study group received ESWT in addition to a conservative physical therapy program for four weeks, while the control group received a conservative physical therapy program only. Pain and functional mobility were assessed before and after treatment through a visual analog scale (VAS) and Victorian Institute of sports assessment - Achilles questionnaire (VISA-A), respectively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Extracorporeal Shockwave Therapy(ESWT), Other: Eccentric training of the calf muscle:, Other: Gastrocnemius, soleus, and hamstring stretchThis group received Extracorporeal Shockwave Therapy(ESWT) + conservative Physical Therapy Treatment (eccentric training + stretching exercise) |
| Control group | Active comparator | Other: Eccentric training of the calf muscle:, Other: Gastrocnemius, soleus, and hamstring stretchThis group received conservative physical therapy treatment(eccentric training + stretching exercise) only. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical history of Achilles tendon pain for at least six months
- A minimum of three months conservative treatment administered without benefit for at least four weeks before ESWT.
Key exclusion criteria (6 listed)
- Patients underwent physical therapy in the four weeks prior enrollment to study.
- Patients had taken non-steroidal anti-inflammatory medication during the previous week
- Patients had received peritendinous injections of a local anesthetic or corticosteroid within last 4 weeks
- Patients had bilateral Achilles tendinopathy
- Patients with other conditions that could significantly contribute to posterior ankle pain (osteoarthritis, radiculopathy, systemic neurologic conditions)
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 |
|---|---|---|
| Extracorporeal Shockwave Therapy(ESWT)Each session of Extracorporeal Shockwave Therapy(ESWT) consists of 2000 pulses with a pressure of 3 bars (equals an energy flux density of 0.1 mJ/mm²), and treatment frequency of 8 pulses/sec | Device | Study group |
| Eccentric training of the calf muscle:The patients were asked to stand with all their body weight on the injured leg on a wooden step. From an upright body position and standing with all body weight on the forefoot, with the ankle joint in plantar flexion. The calf muscle is loaded by having the patient lower the affected limb down by dorsiflexion the ankle until the plantar aspect of the heel lay below the level of the step, and the ankle is in maximum dorsiflexion. | Other | Control group, Study group |
| Gastrocnemius, soleus, and hamstring stretchStretching every muscle for 30 seconds. Each stretch was performed 3 times (holding for 30 seconds and rest for 30 seconds). All these stretches were performed directly after the eccentric exercises twice/day for 7 days/week for weeks | Other | Control group, Study group |
Primary outcome
The Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A).
Time frame: 15 minutes
It consists of eight questions that covered the three domains of pain (questions 1-3), function (questions 4-6), and activity (questions 7 and 8.). Questions one to seven are scored out of 10, and question 8 carries a maximum of 30. Scores are summed to give a total out of 100.
1 secondary outcome
The visual analog scale (VAS).
Time frame: 15 minutes
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 17 Jul 2020.
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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.
Dr. Nasr A. Abdelkader, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy(ESWT), Eccentric training of the calf muscle: and Gastrocnemius, soleus, and hamstring stretch in people with 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 2 inclusion and 6 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 17 Jul 2020. 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 Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A). (time frame: 15 minutes). 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 17 Jul 2020.