Frozen ShoulderNCT05230667

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

A study testing PRP injection (PRP group), Corticosteroid injection (CS group) and Normal saline injection (NS group) in people with Frozen Shoulder and Adhesive Capsulitis, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Frozen Shoulder, Adhesive Capsulitis, Shoulder
What is being tested?: PRP injection (PRP group), Corticosteroid injection (CS group) and Normal saline injection (NS group)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteTaiwan
Study dates: 1 Aug 2022to 31 Jul 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age between 20 to 80 years old;
shoulder pain for ≥ 1 month;
> 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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Shin Kong Wu Ho-Su Memorial Hospital
Taipei

Other trials in Taiwan

About this study

Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection.

Read the 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.

Conditions: Frozen Shoulder, Adhesive Capsulitis, Shoulder, Platelet-rich Plasma, Corticosteroid, Injection
Being tested: PRP injection (PRP group), Corticosteroid injection (CS group), Normal saline injection (NS group)
Keywords: Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection
Medical subject headings: Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRP injection (PRP group)Other
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.
Corticosteroid injection (CS group)Other
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.
Normal saline injection (NS group)Other
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.

Study groups in NCT05230667
Study group	Role	What they receive
PRP injection (PRP group) and physical therapy	Active comparator	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. Receives: Other: Corticosteroid injection (CS group); Other: Normal saline injection (NS group)
Corticosteroid injection (CS group) and physical therapy	Active comparator	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. Receives: Other: PRP injection (PRP group); Other: Normal saline injection (NS group)
Normal saline injection (NS group) and physical therapy	Active comparator	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. Receives: Other: PRP injection (PRP group); Other: Corticosteroid injection (CS group)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

Secondary outcomes (5)

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.
Measured: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
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.
Measured: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
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).
Measured: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
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.
Measured: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
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).
Measured: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202231 Jul 2024

First posted9 Feb 2022
Study start1 Aug 2022
Primary completion31 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Frozen ShoulderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05230667
Sponsor's protocol ID: 20211209R
Other IDs: NSTC 111-2314-B-341-002 -, 2024SKHADR037
Status last verified: Jun 2025
First submitted: 28 Jan 2022
Last updated: 24 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
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All Frozen Shoulder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05230667
Acronym / sponsor ID: 20211209R
Conditions: Frozen Shoulder, Adhesive Capsulitis, Shoulder, Platelet-rich Plasma, Corticosteroid, Injection
Keywords: Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
Study start: 1 Aug 2022 (actual)
Primary completion: 31 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 9 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PRP injection (PRP group) and physical therapy	Active comparator	Other: Corticosteroid injection (CS group), Other: Normal saline injection (NS group)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.
Corticosteroid injection (CS group) and physical therapy	Active comparator	Other: PRP injection (PRP group), Other: Normal saline injection (NS group)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.
Normal saline injection (NS group) and physical therapy	Active comparator	Other: PRP injection (PRP group), Other: Corticosteroid injection (CS group)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.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

age between 20 to 80 years old;
shoulder pain for ≥ 1 month;
> 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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PRP injection (PRP group)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.	Other	Corticosteroid injection (CS group) and physical therapy, Normal saline injection (NS group) and physical therapy
Corticosteroid injection (CS group)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.	Other	Normal saline injection (NS group) and physical therapy, PRP injection (PRP group) and physical therapy
Normal saline injection (NS group)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.	Other	Corticosteroid injection (CS group) and physical therapy, PRP injection (PRP group) and physical therapy

Primary outcome

The Shoulder Pain and Disability Index (SPADI)
Time frame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
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.

5 secondary outcomes

The pain visual analog scale (VAS)
Time frame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Range of motion（ROM）
Time frame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Shoulder Disability Questionnaire（SDQ）
Time frame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
The 36-item Short Form Health Survey（SF-36）
Time frame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Self-assessment of the treatment effect
Time frame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.

Related trials for Frozen Shoulder

Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lin-Fen Hsieh principal investigator

Shin Kong Wu Ho-Su Memorial Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Shoulder Pain and Disability Index (SPADI) (time frame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05230667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.