Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus

Osteochondral Lesion of Talus Clinical Trial

Official title:

Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03750253
• Other study ID #: ESWT
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: July 1, 2019

Study information

• Verified date: March 2019
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study aims to investigate the clinical efficacy of shock wave adjuvant therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy and to provide basis for further popularization and application.

Description:

Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study was conducted to investigate the clinical efficacy of shock wave therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy.

Patients with osteochondral lesions of the talus treated by arthroscopic microfracture surgery and still complained ankle pain three months after surgery were enrolled. Radial extracorporeal shock wave therapy was used to give energy to the injured region of the talus and the adjacent area.Treatment was done once a week for 5 consecutive weeks. After shock wave therapy,the patients were followed by Visual Analogue Scale (VAS), the American Orthopaedic Foot and Ankle Society ankle-hindfoot scale(AOFAS-AHFS) , and followed finally by Magnetic Resonance Imaging(MRI) of the ankle.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: July 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. For arthroscopy:

• Ankle pain, aggravated after exercise or weight-bearing activity, accompanied by lameness, joint stiffness and dysfunction for at least 3 months

• No talar collapse

• Talar cartilage injury cases before stage ? of Hepple classification

2. For shock wave therapy:

• Patients with micro-fractures treated with arthroscopic treatment of talar cartilage injury and were treated with routine rehabilitation training after arthroscopy

• Patients who till complained obvious ankle pain 3 months after surgery

Exclusion Criteria:

• Severe cardiovascular and cerebrovascular diseases

• Hemorrhagic diseases, coagulation disorders

• Bone immaturity

• Thrombosis

• Use of anti-immune agents

• Various types of tumor patients

• Pregnant women

• History of mental illness

• Patients who could not be followed

• Patients with other lower extremity injuries after surgery and were unwilling to participate in the study

Related Conditions & MeSH terms

• Osteochondral Lesion of Talus

Intervention

Other:
• Extracorporeal Shock Wave Therapy
Extracorporeal Shock Wave Therapy will be used for pain-relief after arthroscopy for osteochondral lesions of the talus

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of VAS scores before and after shock wave therapy	The Visual Analogue Scale scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-10 points, and decreases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value < 0.05 is considered as statistically significant.	6 weeks, 12 weeks and last follow-up at an average of 2 years after shock wave therapy
Secondary	Change of AOFAS scores before and after shock wave therapy	The American Orthopaedic Foot & Ankle Society scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-100 points, and increases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value < 0.05 is considered as statistically significant.	6 weeks, 12 weeks and last follow-up last follow-up at an average of 2 years after shock wave therapy