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
Condition: Calcific Tendinitis of the Shoulder
MeSH terms: Tendinopathy
Study type: Interventional

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.
    

Intervention name(s): radial extracorporeal shock wave therapy; ultrasound-guided needle puncture; RSWT and USNP
Intervention type(s): Device; Procedure; Procedure
Intervention description(s): he RSWT was delivered at 2 Hz with 2000 shock waves and the energy level of 0.26mJ/mm2 in calcific tendinitis of shoulder.; 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.; each subject will receive radial shock wave therapy after ultrasound-guided needle puncture, as described in the previous paragraphs.
Other intervention name(s): RSWT; USNP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radial shock wave therapy,calcific tendinitis, ultrasound guidance