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

NCT05034757 | Unknown

• 1 other identifier: 201900290B0A3
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HA; ESWT; non-calcific rotator cuff lesions

Outcome Measures

Primary Outcomes (16)

• Constant Score

  The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record during the treatment course.

  measure and record during the treatment course.

• Constant Score

  The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 1 month after treatment.

  measure and record at 1 month after treatment.

• Constant Score

  The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 3 months after treatment.

  measure and record at 3 months after treatment.

• Constant Score

  The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 6 months after treatment.

  measure and record at 6 months after treatment.

• Constant Score

  The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 12 months after treatment.

  measure and record at 12 months after treatment.

• visual analog scale (VAS)

  Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record during the treatment course.

  measure and record during the treatment course.

• visual analog scale (VAS)

  Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 1 month after treatment.

  measure and record at 1 month after treatment.

• visual analog scale (VAS)

  Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 3 months after treatment.

  measure and record at 3 months after treatment.

• visual analog scale (VAS)

  Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 6 months after treatment.

  measure and record at 6 months after treatment.

• visual analog scale (VAS)

  Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 12 months after treatment.

  measure and record at 12 months after treatment.

• Range of Motion (ROM)

  Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record during the treatment course.

  measure and record during the treatment course.

• Range of Motion (ROM)

  Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 1 month after treatment.

  measure and record at 1 month after treatment.

• Range of Motion (ROM)

  Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 3 months after treatment.

  measure and record at 3 months after treatment.

• Range of Motion (ROM)

  Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 6 months after treatment.

  measure and record at 6 months after treatment.

• Range of Motion (ROM)

  Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 12 months after treatment.

  measure and record at 12 months after treatment.

• MRI

  Take shoulder MRI to compare the difference before and after treatment. The degeneration of the supraspic is graded as: grade 1 ≤ 1/3; 1/3 \< grade 2 \< 2/3; grade 3 ≥ 2/3.

  shoulder MRI will be checked 12 months after treatment

Study Arms (2)

Hyaluronate

EXPERIMENTAL

HA injection

Other: HA only

HA + ESWT

EXPERIMENTAL

HA + ESWT

Other: ESWT once; Other: ESWT twice

Interventions

HA only OTHER

HA injection only

Hyaluronate

ESWT once OTHER

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

HA + ESWT

ESWT twice OTHER

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

HA + ESWT

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain around the shoulder, a positive impingement sign
• Diagnosis of non-calcific rotator cuff pathology without complete tear
• Do not respond to conservative therapy or rehabilitation for at least 3 months

You may not qualify if:

• Rheumatic diseases
• Glenohumeral osteoarthritis
• Full-thickness cuff tears
• Fractures
• Infections
• Tumors
• Received a subacromial injection within 3 weeks
• Pregnant or want to become pregnant.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

Related Publications (1)

• Ko JY, Huang CC, Huang PH, Chen JW, Liao CY, Kuo SJ. Effects of supplementing extracorporeal shockwave therapy to hyaluronic acid injection among patients with rotator cuff lesions without complete tear: a prospective double-blinded randomized study. Int J Surg. 2024 Dec 1;110(12):7421-7433. doi: 10.1097/JS9.0000000000002063.

  PMID: 39172722 DERIVED

Study Officials

• Jih-Yang Ko, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jih-Yang Ko, MD

CONTACT

886-7-731-7123; kojy@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: September 5, 2021
• Study Start: October 31, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

TW (1)