The Development of a Guidance of Combined HA and ESWT for Non-calcific Rotator Cuff Lesions Without Complete Tear

Summary

The rotator cuff lesions are common disorders of the shoulder joint and mainly caused by intrinsic degeneration and outlet impingement. The symptoms include pain, discomfort, weakness, range of motion limitation, and impingement. The initial treatment of rotator cuff lesions are non-surgical especially for non-full thickness tearing and include rehabilitation and medications given orally, topically, or parenterally. Although many patients with rotator cuff lesions or subacromial pain are treated with, and will respond to non- surgical treatment alone, surgical intervention with subacromial decompression and rotator cuff repair is often used as an early treatment choice or in recalcitrant cases. The indications for surgery are persistent and severe shoulder pain combined with functional restrictions that are resistant to conservative measures. However, the effectiveness of this procedure is still elusive. Some studies have compared decompression plus subacromial bursectomy with bursectomy alone and reported no significant difference in clinical outcome between groups.

In addition, arthroscopic subacromial decompression for shouled impingement was currently challenged because some high-quality prospective studies including that from Oxford university showed similar outcomes between surgical and non-surgical treatment. Therefore more efficient non-surgical treatments were needed for the rotator cuff lesions without complete tear.

The investigators have successfully treated non- calcific rotator cuff lesions without complete tearing with hyaluronate and published our data in J Shoulder Elbow surgery. Jun 19:557-63, 2010.

In the Phase III study, the investigators will perform three subacromial hyaluronate injections and zero to two sessions of extracorporeal shock wave therapy (ESWT) for these patients. The investigators hypothesize that through the actions of anti-inflammation, neovascularization and temporary cell permeability increment, a combined therapy of HA and ESWT may offer better therapeutic effects on the non-calcific rotator cuff lesion without complete tearing. The investigators will evaluate the treatment effects with Constant score and VAS scale and also check the changes or expressions of cytokines, growth factors, functional proteins, from the peripheral blood.

Conditions

• Rotator Cuff Lesions

Interventions

OTHER

HA only

HA injection only

OTHER

ESWT once

ESWT of the shoulder the patient will receives STORZ Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder

OTHER

ESWT twice

ESWT of the shoulder the patient will receives STORZ Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  lead OTHER

Principal Investigators

• Jih-Yang Ko, MD · Chang Gung Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-31

Primary Completion

2022-07-31

Completion

2022-07-31

Countries

• Taiwan

Study Locations