The Therapeutic Effect of the Extracorporeal Shock Wave Therapy on Shoulder Calcific Tendinitis

NCT03779919 | Unknown DMC

• 1 other identifier: CMMC10709-004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Calcific tendinopathy of the shoulder is often self-limited with a relatively benign clinical course. Therefore, first-line therapy should be conservative and focused on symptom relief. However, studies show patients with Large volume deposits (e.g. ≥1500 mm3) and Subacromial extension of the deposits respond poorly to initial treatment such as analgesic medication, glucocorticoid injection, and physical therapy. For those refractory cases, extracorporeal shock wave therapy is introduced and shows resolution of symptoms and improvement in shoulder function in approximately 70 percent of patients. Extracorporeal shock wave therapy uses acoustic waves to fragment calcific deposits. Variables of the settings include dose (low or high energy), duration (impulses), and the interval of administration. However, an optimum value for the total cumulative dose of energy that should be administered has not yet been defined. Our study thus aim to find out the dosage effect of ESWT on the calcific debris sizes, pain, daily living functions, and shoulder range of motions in the calcific tendinitis patients.

Conditions

Calcific Tendinitis

Outcome Measures

Primary Outcomes (1)

• changes from baseline in the calcium deposits

  Calcium deposits will be measured via X-ray or sonography.

  one month and 3 months after shock wave

Secondary Outcomes (2)

• functional score

  one month and 3 months after shock wave

• pain score

  one month and 3 months after shock wave

Study Arms (3)

High Energy

EXPERIMENTAL

Extracorporeal shock wave therapy with 0.3 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.

Device: extracorporeal shock wave

Low Energy

EXPERIMENTAL

Extracorporeal shock wave therapy with 0.05 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.

Device: extracorporeal shock wave

Sham

PLACEBO COMPARATOR

Extracorporeal shock wave therapy with 0 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.

Device: extracorporeal shock wave

Interventions

extracorporeal shock wave DEVICE

Extracorporeal shock wave therapy uses acoustic waves to fragment calcific deposits. Variables of the settings include dose (low or high energy), duration (impulses), and the interval of administration.

High Energy; Low Energy; Sham

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ．age 20-70 with calcific tendinitis via sonography or x-ray in rotator cuff

You may not qualify if:

• ．no shoulder fracture, no abnormality, gout or autoimmune disease

Sponsors & Collaborators

• Chimei Medical Center: lead

Study Sites (1)

ChiMei Medical Center

Tainan, Taiwan

RECRUITING

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hsin-Han Cheng, MD

  ChiMei Medical Center, Taiwan, R.O.C.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Ming Lo, MD

CONTACT

+886-6-2612611; loyiming@gmail.com

Hsin-Han Cheng, MD

CONTACT

+886926722119; a11010147@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: November 18, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)