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

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.

Study Overview

• Status: Unknown
• Conditions: Osteochondral Lesion of Talus
• Intervention / Treatment: Other: Extracorporeal Shock Wave Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Southwest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Ⅳ 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Extracorporeal Shock Wave Therapy; Extracorporeal Shock Wave Therapy to relieve pain after arthroscopy for osteochondral lesions of talus	Other: Extracorporeal Shock Wave Therapy; Extracorporeal Shock Wave Therapy will be used for pain-relief after arthroscopy for osteochondral lesions of the talus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Principal Investigator: Xiaojun Duan, M.D., Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): February 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Arthroscopy; Extracorporeal Shock Wave Therapy; Osteochondral Lesions of Talus; Pain-relief
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: ESWT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No