- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04376294
Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy
July 16, 2020 updated by: Nasr Awad Abdelkader Othman, Cairo University
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
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
50
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 Locations
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Giza, Egypt
- Cairo University
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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
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- 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.
Exclusion Criteria:
- 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.
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: Study group
This group received Extracorporeal Shockwave Therapy(ESWT) + conservative Physical Therapy Treatment (eccentric training + stretching exercise)
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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
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.
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
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Active Comparator: Control group
This group received conservative physical therapy treatment(eccentric training + stretching exercise) only.
|
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.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A).
Time Frame: 15 minutes
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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.
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15 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The visual analog scale (VAS).
Time Frame: 15 minutes
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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
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15 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr. Nasr A. Abdelkader, PhD, Cairo University
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)
October 1, 2018
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
May 1, 2020
First Submitted That Met QC Criteria
May 4, 2020
First Posted (Actual)
May 6, 2020
Study Record Updates
Last Update Posted (Actual)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 16, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/002042
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.
Clinical Trials on Achilles Tendinopathy
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University of CalgarySport Science Association of Alberta (SSAA)UnknownAchilles Tendinopathy | Achilles Tendon Enthesopathy | Mid-Portion Achilles Tendinopathy | Insertional Achilles Tendinopathy | Non-Insertional Achilles TendinopathyCanada
-
Krankenhaus Barmherzige Schwestern LinzActive, not recruitingAchilles Tendinopathy | Insertional Achilles TendinopathyAustria
-
University of DelawareActive, not recruitingAchilles Tendinopathy | Achillodynia | Achilles Tendon Pain | Achilles Tendonitis | Achilles DegenerationUnited States
-
Guna S.p.aRecruitingTendinopathy | Achilles Tendinopathy | Insertional Achilles Tendinopathy | PeritendinitisItaly
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Chinese University of Hong KongNot yet recruitingAchilles Tendinopathy | Achilles Tendon RuptureHong Kong
-
Philadelphia College of Osteopathic MedicineRecruitingAchilles Tendinopathy | Achilles Tendon Pain | Achilles Tendonitis | Ankle StrainUnited States
-
University of DelawareRecruitingSever's Disease | Achilles Tendinopathy | Insertional Achilles Tendinopathy | Apophysitis; CalcaneusUnited States
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University of Gran RosarioRecruitingTendon Injuries | Achilles Tendinopathy | Achilles Tendon PainArgentina
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Chinese University of Hong KongNot yet recruiting
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North Park PodiatryRecruiting
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