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

NCT03750253 | Unknown

• 1 other identifier: ESWT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondral Lesion of Talus

Keywords

Extracorporeal Shock Wave Therapy; Osteochondral Lesions of Talus; Arthroscopy; Pain-relief

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (1)

Extracorporeal Shock Wave Therapy

OTHER

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

Other: Extracorporeal Shock Wave Therapy

Interventions

Extracorporeal Shock Wave Therapy OTHER

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

Extracorporeal Shock Wave Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Southwest Hospital

Chongqing, China

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Xiaojun Duan, M.D.

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Center for Joint Surgery

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 23, 2018
• Study Start: March 1, 2013
• Primary Completion: February 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)