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Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder

Primary Purpose

Frozen Shoulder, Adhesive Capsulitis, Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PRP injection (PRP group)
Corticosteroid injection (CS group)
Normal saline injection (NS group)
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. . age between 20 to 80 years old;
  2. . shoulder pain for ≥ 1 months;
  3. . > 30% loss of passive range of motion (ROM) of the affected shoulder in external rotation and/or abduction, comparing with the sound side;
  4. . visual analog scale for pain on maximal passive external rotation or abduction > 4;
  5. an empty or soft end feel on passive external rotation, or abduction and/or presence of night pain or rest pain;
  6. showing willing to attend regular physical therapy programs for 8 weeks.

Exclusion Criteria:

  1. . severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
  2. . uncontrolled DM;
  3. . rotator cuff tear or calcification of the affected shoulder;
  4. . fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
  5. . a hard end feel on passive external rotation or abduction of the affected shoulder;
  6. . a history of drug allergy to local anesthetics or corticosteroids;
  7. . receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

PRP injection (PRP group) and physical therapy

Corticosteroid injection (CS group) and physical therapy

Normal saline injection (NS group) and physical therapy

Arm Description

Patients in the PRP group will receive both shoulder joint (GHJ) and SASD bursa injection for 2 times in 2-week interval. PRP will be prepared by taking 10ml venous blood which is then mixed with 2ml of thrombin and centrifuged in a specially designed tube at 3400 rotations per minute (rpm) for 15 minutes. About 2ml PRP and 3ml platelet poor plasma (PPP) will be extracted, then 4ml 1% xylocaine will be added to make 9ml injectate. 6ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. Another 3ml injectate will be injected into the SASD bursa of the affected shoulder with a 3.8 cm 22-gauge needle under US guidance. Physical therapy will be conducted for 8 weeks.

Three ml triamcinolone (1ml= 10mg), 4ml 1% xylocain, and 2ml normal saline to make a 9ml injectate is injected into the affected shoulder (6ml to posterior GHJ and 3 ml to SASD bursa) for 2 times in 2-week interval. The techniques of injection are the same as those used in the PRP injection. Physical therapy will be conducted for 8 weeks.

Four 4ml 1% xylocaine mixed with 5ml normal saline will be injected into the affected GHJ (6ml) and SASD bursa (3ml) for 2 times in 2-week interval . The techniques of injection are the same as those used in the PRP injection. Physical therapy will be conducted for 8 weeks.

Outcomes

Primary Outcome Measures

The Shoulder Pain and Disability Index (SPADI)
The SPADI is a self-administered questionnaire that evaluate the pain and disability of shoulder diseases. It has 2 subclasses (pain and disability) that consists of 13 items. The pain domain has 5 items and the disabilities domain has 8 items. The SPADI score, which ranges between 0 (best score) and 100 (worst score), is calculated by averaging the scores from the 2 subclasses.

Secondary Outcome Measures

The pain visual analog scale (VAS)
The pain VAS is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain.22 The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of pain VAS is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated.
Range of motion（ROM）
All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction.
Shoulder Disability Questionnaire（SDQ）
The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are "yes," "no," and "not applicable." The final score is calculated by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst possible condition).
The 36-item Short Form Health Survey（SF-36）
The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health.
Self-assessment of the treatment effect
Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=5, effective=4, same=3, worse=2, much worse=1).

Full Information

First Posted
January 28, 2022
Last Updated
October 3, 2023
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05230667
Brief Title
Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder
Official Title
Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection.
Detailed Description
This is a prospective assessor-blinded randomized controlled trial. We plan to enroll 90 participants with frozen shoulder from the outpatient clinic of the Department of Physical Medicine and Rehabilitation in our hospital. The study protocol and consent form have been approved by our ethics committee. After detailed explanation about the content of this study, participant is asked to sign an informed consent. The patients will be randomly divided into three groups: 1). PRP injection (PRP group); 2). Corticosteroid injection (CS group); 3). Normal saline injection (NS group). Randomization will be assigned according to a random number from a computer program by a statistician. The patients and the evaluator are unknown which group the patients are allocated, but the physician who performs joint injection knows which group the patients are assigned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder, Adhesive Capsulitis, Shoulder, Platelet-rich Plasma, Corticosteroid, Injection
Keywords
Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP injection (PRP group) and physical therapy
Arm Type
Active Comparator
Arm Description
Patients in the PRP group will receive both shoulder joint (GHJ) and SASD bursa injection for 2 times in 2-week interval. PRP will be prepared by taking 10ml venous blood which is then mixed with 2ml of thrombin and centrifuged in a specially designed tube at 3400 rotations per minute (rpm) for 15 minutes. About 2ml PRP and 3ml platelet poor plasma (PPP) will be extracted, then 4ml 1% xylocaine will be added to make 9ml injectate. 6ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. Another 3ml injectate will be injected into the SASD bursa of the affected shoulder with a 3.8 cm 22-gauge needle under US guidance. Physical therapy will be conducted for 8 weeks.
Arm Title
Corticosteroid injection (CS group) and physical therapy
Arm Type
Active Comparator
Arm Description
Three ml triamcinolone (1ml= 10mg), 4ml 1% xylocain, and 2ml normal saline to make a 9ml injectate is injected into the affected shoulder (6ml to posterior GHJ and 3 ml to SASD bursa) for 2 times in 2-week interval. The techniques of injection are the same as those used in the PRP injection. Physical therapy will be conducted for 8 weeks.
Arm Title
Normal saline injection (NS group) and physical therapy
Arm Type
Active Comparator
Arm Description
Four 4ml 1% xylocaine mixed with 5ml normal saline will be injected into the affected GHJ (6ml) and SASD bursa (3ml) for 2 times in 2-week interval . The techniques of injection are the same as those used in the PRP injection. Physical therapy will be conducted for 8 weeks.
Intervention Type
Other
Intervention Name(s)
PRP injection (PRP group)
Intervention Description
Patients in the PRP group will receive both shoulder joint (GHJ) and SASD bursa injection for one time. PRP will be prepared by taking 10ml venous blood which is then mixed with 2ml of thrombin and centrifuged in a specially designed tube at 3400 rotations per minute (rpm) for 15 minutes. About 2ml PRP and 3ml platelet poor plasma (PPP) will be extracted, then 4ml 1% xylocaine will be added to make 9ml injectate. 6ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. Another 3ml injectate will be injected into the SASD bursa of the affected shoulder with a 3.8 cm 22-gauge needle under US guidance.
Intervention Type
Other
Intervention Name(s)
Corticosteroid injection (CS group)
Intervention Description
Three ml triamcinolone (1ml= 10mg), 4ml 1% xylocain, and 2ml normal saline to make a 9ml injectate is injected into the affected shoulder (6ml to posterior GHJ and 3 ml to SASD bursa). The techniques of injection are the same as those used in the PRP injection.
Intervention Type
Other
Intervention Name(s)
Normal saline injection (NS group)
Intervention Description
Four 4ml 1% xylocaine mixed with 5ml normal saline will be injected into the affected GHJ (6ml) and SASD bursa (3ml). The techniques of injection are the same as those used in the PRP injection.
Primary Outcome Measure Information:
Title
The Shoulder Pain and Disability Index (SPADI)
Description
The SPADI is a self-administered questionnaire that evaluate the pain and disability of shoulder diseases. It has 2 subclasses (pain and disability) that consists of 13 items. The pain domain has 5 items and the disabilities domain has 8 items. The SPADI score, which ranges between 0 (best score) and 100 (worst score), is calculated by averaging the scores from the 2 subclasses.
Time Frame
Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary Outcome Measure Information:
Title
The pain visual analog scale (VAS)
Description
The pain VAS is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain.22 The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of pain VAS is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated.
Time Frame
Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Title
Range of motion（ROM）
Description
All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction.
Time Frame
Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Title
Shoulder Disability Questionnaire（SDQ）
Description
The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are "yes," "no," and "not applicable." The final score is calculated by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst possible condition).
Time Frame
Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Title
The 36-item Short Form Health Survey（SF-36）
Description
The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health.
Time Frame
Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Title
Self-assessment of the treatment effect
Description
Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=5, effective=4, same=3, worse=2, much worse=1).
Time Frame
Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: . age between 20 to 80 years old; . shoulder pain for ≥ 1 months; . > 30% loss of passive range of motion (ROM) of the affected shoulder in external rotation and/or abduction, comparing with the sound side; . visual analog scale for pain on maximal passive external rotation or abduction > 4; an empty or soft end feel on passive external rotation, or abduction and/or presence of night pain or rest pain; showing willing to attend regular physical therapy programs for 8 weeks. Exclusion Criteria: . severe systemic disorders including cancer, stroke, or cardiopulmonary diseases; . uncontrolled DM; . rotator cuff tear or calcification of the affected shoulder; . fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders; . a hard end feel on passive external rotation or abduction of the affected shoulder; . a history of drug allergy to local anesthetics or corticosteroids; . receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin-Fen Hsieh, M.D.
Phone
+886-28332211
Ext
2538
Email
M001026@ms.skh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh, M.D.
Phone
+886-28332211
Ext
2538
Email
M001026@ms.skh.org.tw

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder

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