Comparison of the Effect of Radial Shock Wave, Ultrasound-guided Needle Puncture, and Combination of Both in the Treatment of Calcific Tendinitis of the Shoulder

NCT ID: NCT02677103

Last Updated: 2016-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-08-31

Brief Summary

Calcific tendinitis of the shoulder is a common enthesopathy, and is characterized by inflammation around calcium hydroxyapatite crystal deposits, usually located in the supraspinatus tendon, near its insertion place.1 The disease mainly affects individuals between 30 and 50 years of age, is painful in 50% of patients and frequently leads to considerable restriction of motion.2,3 It goes through three distinct stages: a precalcific stage (metaplasia of matrix), calcific stage (calcification of matrix and resorption of calific deposits), and a postcalcific stage (reconstitution of matrix).

Classifications of calcific tendinitis have been proposed previously. Gartner proposed a classification based on plain films of the shoulder: type I deposits were sharply outlined and densely structured. Type III deposits had a cloudy outline and were transparent in structure. Type II deposits were features of both.4 Type III plaques have a tendency to resorb. Due to the progress of musculoskeletal ultrasound over the past decade, classification of the calcific tendinitis based on ultrasound findings was also proposed: arc-shaped (an echogenic arc with clear shadowing), fragmented or punctate (at least 2 separated echogenic spots or plaques with or without shadowing), nodular (an echogenic nodule without shadowing), and cystic (a bold echogenic wall with an anechoic area).5 Plaques that appear fragmented, nodular, or cystic on ultrasound are considered in the resorptive phase.

The treatment of patients with calcific tendinitis is typically conservative. The reported success rates vary between 30 and 85%.6 If the pain becomes chronic or intermittent after several months of conservative treatment, arthroscopic and open procedures are available to curette the calcium deposit, and additional subacromial decompression can be performed if necessary.7,8 As an alternative, minimally invasive extracorporeal shock wave therapy (ESWT) has been postulated to be an effective treatment option for treating calcific tendinopathy of the shoulder, before surgery.9-12 In recent years, radial shock wave has been developed. A radial shock wave is a low- to medium-energy shock wave that is pneumatically generated through acceleration of a projectile inside the handpiece of the treatment device and then transmitted radially from the tip of the applicator to the target zone. Radial shock wave showed a low pressure and a considerably longer rise time than extracorporeal shock wave. In radial shock wave therapy (RSWT), the focal point is not concentrated on the target zone, as occurred in ESWT, but on the tip of applicator. 13 Another new method of conservative treatment of calcific tendinopathy is ultrasound-guided fine-needle repeated puncture of the calcific plaque, as shown in previous study.14,15 The new method has the advantage of being easily operative, cheap, safe, and has a proven high success rate. Although percutaneous needle aspiration with a large size needle(≥ 18# needle) alleviates symptoms in up to 60% of patients and resolves the deposits in 40% to 74%,16,17 the larger size needle could result in tendon injury.

In clinical practice, combination of radial shock wave therapy and ultrasound-guided fine needle repeated puncture is frequently used and shows promising results, however, scientific report has been rarely published before.18 The purpose of this study is to compare the efficacy of RSWT, ultrasound-guided fine needle puncture (USNP), and combination of RSWT and USNP in the treatment of calcific tendinitis of shoulder.

Detailed Description

A prospective, randomized, controlled trial will be conducted.Thirty patients in each group with calcific tendinitis of shoulder from the outpatient clinic of Department of Physical Medicine and Rehabilitation in Shin Kong Wu Ho-Su Memorial Hospital.

Conditions

Calcific Tendinitis of the Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RSWT group

The RSWT was delivered at 2 Hz with 2000 shock waves and the energy level of 0.26mJ/mm2 in calcific tendinitis of shoulder. RSWT will be performed once per week, and will be continued for 3 weeks.

Group Type: EXPERIMENTAL

radial extracorporeal shock wave therapy

Intervention Type: DEVICE

he RSWT was delivered at 2 Hz with 2000 shock waves and the energy level of 0.26mJ/mm2 in calcific tendinitis of shoulder.

USNP group

All needle punctures will be guided by ultrasound (US). The puncture needle is a 3.8cm 22# needle attached on a 5ml syringe. Before puncture, the skin of the puncture site will be sterilized with better iodine, and the transducer will be covered with a sterilized plastic bag. After injecting 3cc 1% Xylocain in the subcutaneous tissue, muscle layer and subdeltoid bursa, multiple back-and-forth puncture about 10-20 times (depending on the size of the plaques) within the calcific plaques will be performed. The needle tract will be monitored by ultrasound to make sure the needle penetrated through the calcific plaque, but does not penetrate the rotator cuff.

Group Type: EXPERIMENTAL

ultrasound-guided needle puncture

Intervention Type: PROCEDURE

After injecting 3cc 1% Xylocain in the subcutaneous tissue, muscle layer and subdeltoid bursa, multiple back-and-forth puncture about 10-20 times (depending on the size of the plaques) within the calcific plaques will be performed.

RSWT plus USNP

In this group, each subject will receive radial shock wave therapy after ultrasound-guided needle puncture, as described in the previous paragraphs

Group Type: EXPERIMENTAL

RSWT and USNP

Intervention Type: PROCEDURE

each subject will receive radial shock wave therapy after ultrasound-guided needle puncture, as described in the previous paragraphs.

Interventions

radial extracorporeal shock wave therapy

he RSWT was delivered at 2 Hz with 2000 shock waves and the energy level of 0.26mJ/mm2 in calcific tendinitis of shoulder.

Intervention Type: DEVICE

ultrasound-guided needle puncture

After injecting 3cc 1% Xylocain in the subcutaneous tissue, muscle layer and subdeltoid bursa, multiple back-and-forth puncture about 10-20 times (depending on the size of the plaques) within the calcific plaques will be performed.

Intervention Type: PROCEDURE

RSWT and USNP

each subject will receive radial shock wave therapy after ultrasound-guided needle puncture, as described in the previous paragraphs.

Intervention Type: PROCEDURE

Other Intervention Names

RSWT; USNP

Eligibility Criteria

Inclusion Criteria

1. Age 20~75 y

2. Subject with calcific tendinitis of the shoulder.

Exclusion Criteria

pregnancy, clotting disorders, anticoagulant or antiplatelet treatment, cardiac pacemaker, chronic inflammatory joint disease, infections or tumors of the shoulder, adhesive capsulitis, hyperalgia of the shoulder due to resorption of a calcific deposit, and calcification of type III as defined by Gartner or nodular or cystic type of calcification defined by Chiou.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin-Fen Hsieh, M.D

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

20120801R

Identifier Type: -

Identifier Source: org_study_id