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

Primary Purpose

Osteochondral Lesion of Talus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteochondral Lesion of Talus focused on measuring Extracorporeal Shock Wave Therapy, Osteochondral Lesions of Talus, Arthroscopy, Pain-relief

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Extracorporeal Shock Wave Therapy

Arm Description

Extracorporeal Shock Wave Therapy to relieve pain after arthroscopy for osteochondral lesions of talus

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 18, 2018
Last Updated
March 20, 2019
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03750253
Brief Title
Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus
Official Title
Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteochondral Lesion of Talus
Keywords
Extracorporeal Shock Wave Therapy, Osteochondral Lesions of Talus, Arthroscopy, Pain-relief

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal Shock Wave Therapy
Arm Type
Other
Arm Description
Extracorporeal Shock Wave Therapy to relieve pain after arthroscopy for osteochondral lesions of talus
Intervention Type
Other
Intervention Name(s)
Extracorporeal Shock Wave Therapy
Intervention Description
Extracorporeal Shock Wave Therapy will be used for pain-relief after arthroscopy for osteochondral lesions of the talus
Primary Outcome Measure Information:
Title
Change of VAS scores before and after shock wave therapy
Description
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.
Time Frame
6 weeks, 12 weeks and last follow-up at an average of 2 years after shock wave therapy
Secondary Outcome Measure Information:
Title
Change of AOFAS scores before and after shock wave therapy
Description
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.
Time Frame
6 weeks, 12 weeks and last follow-up last follow-up at an average of 2 years after shock wave therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Duan, M.D.
Organizational Affiliation
Southwest Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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