The Clinical and Biological Effect of ESWT With Combined PRP Therapy on Rotator Cuff Lesions

NCT05032924 | Unknown

• 1 other identifier: 202100718A3A3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Through the investigators previous study of the effect of transient increased cellular permeability after ESWT, combined ESWT and PRP may have better effect on the treatment of rotator cuff lesions. The investigators intend to conduct a prospective double blind randomized control study on the treatment effect of combined ESWT and PRP therapy for rotator cuff lesions without complete tearing. Constant Score, VAS and data from peripheral blood will be measured for the effectiveness evaluation. Shoulder MRI will be followed-up one year after ESWT. The investigators hypothesize that combined ESWT and PRP will be more effective for rotator cuff lesions.

Conditions

Rotator Cuff Lesions

Keywords

Platelet Rich Plasma (PRP); Extracorporeal shock wave therapy (ESWT)

Outcome Measures

Primary Outcomes (13)

• 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 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 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)

PPR group

EXPERIMENTAL

Receive PRP injection only (PRP form Regen Kit BCT 1)

Combination Product: PPR group with ESWT; Combination Product: PPR group without ESWT

HA group

PLACEBO COMPARATOR

Receive HA injection only (HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe)

Combination Product: HA group with ESWT; Combination Product: HA group without ESWT

Interventions

PPR group with ESWT COMBINATION_PRODUCT

extracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy) (3000 impulse, each point, 24 KV, 0.32 mJ/mm2) one week after PRP or HA injection

PPR group

PPR group without ESWT COMBINATION_PRODUCT

PRP or HA injection only

PPR group

HA group with ESWT COMBINATION_PRODUCT

extracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy)

HA group

HA group without ESWT COMBINATION_PRODUCT

PRP or HA injection only

HA group

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, imaging diagnosis of rotator cuff pathology without complete tear
• do not respond to conservative therapy or rehabilitation for at least 3 months
• age between 35 and 80 years, who sign the informed consent form.

You may not qualify if:

• rheumatic diseases, SLE, diabetic neuropathy, glenohumeral osteoarthritis, full-thickness cuff tears, fractures, infections, or tumors
• received a subacromial injection within 3 weeks
• pregnant or want to become pregnant.
• arrhythmia, pacemaker, coagulopathy, or malignancy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Medical Hosptial

Kaohsiung City, 833, Taiwan

RECRUITING

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

Model Details: Participants are randomly into four group to receive either shockwave or PRP or sham (HA) treatment based on a computerized statistical randomization. Every participant will have Subacromial injection of 2.5 ml PRP form Regen Kit BCT 1 or HA (control)(HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe) one week before ESWT or sham therapy. Follow-up examinations are performed independently by one of the coauthors, who is blinded to patient treatment status at 1week, 2week, 1month, 3 months, 6 months, and 12 months after treatment. Peripheral blood (10cc) will be collected one week and 1 month after treatment and shoulder MRI will be checked 12 months after treatment. Participants who have persistent shoulder discomfort may be advised to undergo surgical intervention.

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: September 2, 2021
• Study Start: August 2, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

TW (1)