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CompletedNCT04376294Updated Jul 17, 2020

Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy

An interventional study of Extracorporeal Shockwave Therapy(ESWT) and Eccentric training of the calf muscle: in Achilles Tendinopathy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-07-17.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Oct 2018, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Achilles Tendinopathy

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03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Study group

    This group received Extracorporeal Shockwave Therapy(ESWT) + conservative Physical Therapy Treatment (eccentric training + stretching exercise)

    Device: Extracorporeal Shockwave Therapy(ESWT) · Other: Eccentric training of the calf muscle: · Other: Gastrocnemius, soleus, and hamstring stretch

  • Active comparator
    Control group

    This group received conservative physical therapy treatment(eccentric training + stretching exercise) only.

    Other: Eccentric training of the calf muscle: · Other: Gastrocnemius, soleus, and hamstring stretch

Interventions

  • DeviceExtracorporeal 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

  • OtherEccentric 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.

  • OtherGastrocnemius, soleus, and hamstring stretch

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: 15 minutes

07

Study locations

1 site
  • Cairo university
    Giza, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04376294
Lead sponsor
Cairo University
Collaborators
Prof.Dr. Emad Samuel Boles Saweeres, Prof.Dr Nadia Abdelazim fayaz, Mr.Mohamed Nasser Kise Helmy
Responsible party
Nasr Awad Abdelkader Othman (Lecturer, Cairo University) — Principal investigator
First posted
May 6, 2020
Start date
Oct 1, 2018
Primary completion
Dec 31, 2018
Completion
Jun 1, 2020
Last update
Jul 17, 2020

Study contacts

Dr. Nasr A. Abdelkader, PhD
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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