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Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy

Primary Purpose

Achilles Tendinopathy

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Extracorporeal Shockwave Therapy(ESWT)

Eccentric training of the calf muscle:

Gastrocnemius, soleus, and hamstring stretch

About this trial

This is an interventional treatment trial for Achilles Tendinopathy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04376294

First Posted

May 1, 2020

Last Updated

July 16, 2020

Sponsor

Cairo University

Collaborators

Prof.Dr. Emad Samuel Boles Saweeres, Prof.Dr Nadia Abdelazim fayaz, Mr.Mohamed Nasser Kise Helmy

1. Study Identification

Unique Protocol Identification Number

NCT04376294

Brief Title

Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy

Official Title

Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

Collaborators

Prof.Dr. Emad Samuel Boles Saweeres, Prof.Dr Nadia Abdelazim fayaz, Mr.Mohamed Nasser Kise Helmy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achilles Tendinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Extracorporeal Shockwave Therapy(ESWT)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Eccentric training of the calf muscle:

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Gastrocnemius, soleus, and hamstring stretch

Intervention Description

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

Primary Outcome Measure Information:

Title

The Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A).

Description

Time Frame

15 minutes

Secondary Outcome Measure Information:

Title

The visual analog scale (VAS).

Description

Time Frame

15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Nasr A. Abdelkader, PhD

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo university

City

Giza

Country

Egypt

12. IPD Sharing Statement

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Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy

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