Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy

NCT ID: NCT04376294

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-06-01

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

Conditions

Achilles Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

Extracorporeal Shockwave Therapy(ESWT)

Intervention Type: 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:

Intervention Type: 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 stretch

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Eccentric training of the calf muscle:

Intervention Type: 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 stretch

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Gastrocnemius, 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof.Dr. Emad Samuel Boles Saweeres

UNKNOWN

Sponsor Role: collaborator

Prof.Dr Nadia Abdelazim fayaz

UNKNOWN

Sponsor Role: collaborator

Mr.Mohamed Nasser Kise Helmy

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nasr Awad Abdelkader Othman

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Nasr A. Abdelkader, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/002042

Identifier Type: -

Identifier Source: org_study_id