Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy

NCT04376294 | Completed

• 1 other identifier: P.T.REC/012/002042
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Achilles Tendinopathy

Outcome Measures

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.

  15 minutes

Secondary Outcomes (1)

• The visual analog scale (VAS).

  15 minutes

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

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

Study group

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.

Control group; Study group

Gastrocnemius, soleus, and hamstring stretch OTHER

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

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Prof.Dr. Emad Samuel Boles Saweeres: collaborator
• Prof.Dr Nadia Abdelazim fayaz: collaborator
• Mr.Mohamed Nasser Kise Helmy: collaborator

Study Sites (1)

Cairo university

Giza, Egypt

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Dr. Nasr A. Abdelkader, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 6, 2020
• Study Start: October 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: June 1, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

EG (1)