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

NCT02677103 | Completed DMC

• 1 other identifier: 20120801R
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcific Tendinitis of the Shoulder

Keywords

Radial shock wave therapy,calcific tendinitis, ultrasound guidance

Outcome Measures

Primary Outcomes (1)

• Pain (VAS)

  VAS; horizontal lines of 100 mm, with 0 indicating no pain on the left and 100 indicating very severe pain on the right. A VAS has been found to be reliable and sensitive tool for measuring pain, with test-retest reliability of \>0.90. In previous studies of subjects treated for various shoulder disorders, the responsiveness of VAS for pain was moderate to good.

  1.5 month, 3 months after the treatment.

Secondary Outcomes (4)

• Active ROM and passive ROM

  .5 month, 3 months after the treatment.

• General health status: 36-Item Shot-Form Health Survey (SF-36)

  1.5 month, 3 months after the treatment.

• Shoulder problems

  .5 month, 3 months after the treatment.

• Patients' satisfaction

  1.5 month, 3 months after the treatment.

Study Arms (3)

RSWT group

EXPERIMENTAL

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.

Device: radial extracorporeal shock wave therapy

USNP group

EXPERIMENTAL

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.

Procedure: ultrasound-guided needle puncture

RSWT plus USNP

EXPERIMENTAL

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

Procedure: RSWT and USNP

Interventions

radial extracorporeal shock wave therapy 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.

Also known as: RSWT

RSWT group

ultrasound-guided needle puncture 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.

Also known as: USNP

USNP group

RSWT and USNP PROCEDURE

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

RSWT plus USNP

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20\~75 y
• Subject with calcific tendinitis of the shoulder.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Study Officials

• Lin-Fen Hsieh, M.D

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: February 9, 2016
• Study Start: April 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

TW (1)