NCT02450864

Brief Summary

Investigators recent data showed anti-inflammatory effect of Effect of Extracorporeal Shockwave Technology (ESWT). Little studies focused on the effect and pathomechanism of ESWT on shoulder stiffness.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

6.6 years

First QC Date

April 13, 2015

Last Update Submit

February 5, 2017

Conditions

Stiffness of Shoulder, Not Elsewhere Classified

Keywords

Stiffness of Shoulder, Not Elsewhere Classified

Outcome Measures

Primary Outcomes (1)

  • the range of motion (ROM) of the shoulder as a measure

    Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD \>270degrees.

    1weeks

Study Arms (2)

patient with ESWT

EXPERIMENTAL

Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD \>270degrees.

Other: ESWT

patient without ESWT

SHAM COMPARATOR

Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD \>270degrees.

Other: ESWT

Interventions

ESWTOTHER

Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD \>270degrees.

patient with ESWTpatient without ESWT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 to 80 years
  • receiving surgery for open acromioplasty

You may not qualify if:

  • shoulder disorders caused by traumatic fracture
  • previous surgery
  • osteoarthritis
  • malignant disorders
  • hepatic disorders
  • renal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

Study Officials

  • Jih-Yang Jih-Yang, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jih-Yang Jih-Yang, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

May 21, 2015

Study Start

January 1, 2013

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

TW(1)