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

• Sponsor: Southwest Hospital, China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03750253
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 76
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteochondral Lesion of Talus	Other: Extracorporeal Shock Wave Therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus
• Actual Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Feb 1, 2019
• Anticipated Study Completion Date: Jul 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of VAS scores before and after shock wave therapy [6 weeks, 12 weeks and last follow-up at an average of 2 years 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.

Secondary Outcome Measures

1. Change of AOFAS scores before and after shock wave therapy [6 weeks, 12 weeks and last follow-up last follow-up at an average of 2 years 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Hospital	Chongqing		China

Sponsors and Collaborators

• Southwest Hospital, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaojun Duan, Deputy Director of the Center for Joint Surgery, Southwest Hospital, China
• ClinicalTrials.gov Identifier: NCT03750253
• Other Study ID Numbers: ESWT
• First Posted: Nov 23, 2018
• Last Update Posted: Mar 22, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaojun Duan, Deputy Director of the Center for Joint Surgery, Southwest Hospital, China: Extracorporeal Shock Wave Therapy; Osteochondral Lesions of Talus; Arthroscopy; Pain-relief
• Additional relevant MeSH terms: Shock

Study Results

No Results Posted as of Mar 22, 2019