Clinical trial NCT03750253: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteochondral Lesion of Talus
Keywords: Extracorporeal Shock Wave Therapy
Osteochondral Lesions of Talus
Arthroscopy
Pain-relief
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of VAS scores before and after shock wave therapy
timeFrame: 6 weeks, 12 weeks and last follow-up at an average of 2 years after shock wave therapy
Secondary outcomes:
measure: Change of AOFAS scores before and after shock wave therapy
timeFrame: 6 weeks, 12 weeks and last follow-up last follow-up at an average of 2 years after shock wave therapy
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
Study officials:
affiliation: Southwest Hospital, China
name: Xiaojun Duan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: