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Frozen ShoulderNCT06491745

Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder

A study testing ESWT+PT+corticosteroid injection, ESWT group in people with Frozen Shoulder and Corticosteroid Injection, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Frozen shoulder, or adhesive capsulitis of the shoulder, is a common clinical problem characterized by pain, loss of both passive and active range of motion (ROM) of glenohumeral joint (GHJ), leads to functional limitation, and reduces quality of life. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
ESWT+PT+corticosteroid injection, ESWT group
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
1 siteTaiwan
Study dates
1 Aug 2024to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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;
  • pain visual analog scale on maximal passive external rotation or abduction > 4;
  • showing willing to receive ESWT, shoulder joint injection, and 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 history of drug allergy to local anesthetics or corticosteroids;
  • pregnancy;
  • receiving ESWT, corticosteroid joint or bursa injection of the affected shoulder during the preceding three months

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei

    Lin-Fen Hsieh, M.D., +886-28332211 ext. 2538, M001026@ms.skh.org.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder?

Frozen shoulder, or adhesive capsulitis of the shoulder, is a common clinical problem characterized by pain, loss of both passive and active range of motion (ROM) of glenohumeral joint (GHJ), leads to functional limitation, and reduces quality of life. Primary frozen shoulder occurs without any obvious connection to any other condition, and secondary frozen shoulder is related to some medical problems, such as an injury, inflammatory, immunological, and endocrine conditions, or surgery of the shoulder. The prevalence of frozen shoulder is 2%-5% in general population, usually between 40 to 60 years old, and more in female. Diabetes patients have more chance of developing frozen shoulder than general population and the prevalence was 13.4%.

Frozen shoulder is clinically divided into 3 overlapping phases. The painful freezing phase has a duration of 10 to 36 weeks and is characterized by pain and stiffness around the shoulder, which may worsen at night. The frozen phase is characterized by restricted ROM with a gradual relief of pain, which occurs at 4 to 12 months. The thawing phase with spontaneous improvement in the ROM takes 12 to 42 months. .Although frozen shoulder is a self-limited condition, the recovery may be slow and incomplete.

Read more

Treatment of frozen shoulder consists of physiotherapy, oral medication (nonsteroidal anti-inflammatory drugs or corticosteroid), intra-articular corticosteroid injection, hydrodilatation, suprascapular nerve block, mobilization, manipulation under anesthesia, and operative intervention (arthroscopic release or open release). Because of the uncertainty of the efficacy and risk of surgical treatment, nonsurgical treatments are more likely chosen by patients. Among them, intra-articular steroid injection and physical therapy are commonly used nonsurgical treatments and have shown some benefits. .Because the clinical picture of frozen shoulder may be similar to, or combining with chronic subacromial bursitis, especially in the freezing stage, concomitant subacromial/subdeltoid (SASD) bursa injection may be needed for treatment of frozen shoulder. In addition, the 3 stages of frozen shoulder often overlap and the clinical symptoms of patients are complex, adjuvant therapy is often needed throughout the course of treatment. Even after physical therapy (PT) and corticosteroid injection, mild to moderate contracture, especially external rotation, abduction, and internal rotation may still be present.

Over the past few years new evidence has emerged on the effectiveness of extracorporeal shock wave therapy (ESWT) in the treatment of many musculoskeletal disorders. Briefly, ESWT has been shown to promote neovasculization, amplify growth factor and protein synthesis, increase of pain inhibiting substance, alteration of pain receptor neurotransmission, and intensification of tissue regeneration. Furthermore, ESWT can produce a cavitation effect between tissues, cause intertissue release, promote the separation of adhesion, and release the adhesive tissue. Because of its analgesic, anti-fibrotic, and anti-inflammatory effect, application of ESWT as main treatment or an adjunct to other interventions has been tried. Knoblock et al found that focused ESWT can reduce pain in painful nodules in Dupuytren's disease; in a randomized controlled trial Chen et al showed focused ESWT was superior to oral corticosteroid for frozen shoulder, although oral corticosteroid is not commonly prescribed for patients with frozen shoulder. Vahdatpour compared ESWT with sham ESWT on treatment of frozen shoulder after 40mg triamcinolone intra-articular injection, and found that ESWT group seemed to have positive effects on treatment, and quicker return to daily life. Another two studies investigating application of radial shock wave to patients with frozen shoulder showed improvement of ROM, even for diabetic patients. A systemic review and meta-analysis also showed ESWT seems beneficial to patients with frozen shoulder and could be used as an adjunct therapy to routine treatments. However, the authors mentioned that the quality of the included randomized controlled trials were hampered by significant heterogeneity regarding long-term analgesia and joint ROM.

Because the effect of ESWT against frozen shoulder has not been well established, we aim to investigate whether adding ESWT to corticosteroid injection and routine PT beneficial for patients with frozen shoulder? We hypothesize that ESWT would be a positive adjunctive therapy in the treatment of frozen shoulder.

Read the detailed description

Intra-articular and subdeltoid bursal corticosteroid injection and physical therapy (PT) are commonly used nonsurgical treatments for frozen shoulder and have shown good benefits. However, because of complex clinical pictures and overlapping stages, even after the above treatments, pain and contracture of affected shoulder may still exist, and adjuvant therapy is often needed throughout the course of treatment. Over the past few years new evidence has emerged on the effectiveness of extracorporeal shock wave therapy (ESWT) in the treatment of many musculoskeletal disorders. Because of its analgesic, anti-fibrotic effect, and anti-inflammatory effect, application of ESWT to frozen shoulder as an adjunct to other interventions has been tried. However, up to now the effect of ESWT against frozen shoulder has not been well established. We aim to investigate whether adding ESWT to corticosteroid injection and routine PT beneficial for patients with frozen shoulder? This is a prospective single-blind randomized controlled trial. Ninety-four participants with primary frozen shoulder will be recruited from the outpatient clinic of the department of Physical Medicine and Rehabilitation of Shin Kong Wu Ho-Su Memorial Hospital and randomly divided into ESWT group and SHAM group. Each subject in the ESWT group will receive 4 times of ESWT at weekly interval; while participants in the SHAM group receive 4 times of sham ESWT (minimal energy) at weekly interval. Participants in each group also receive 2 times of intraarticular and subdeltoid bursa corticosteroid injection at 2-weekly interval and 8-week physical therapy program.

Outcome measures include the pain visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), the Shoulder Disability Questionnaire (SDQ), active and passive range of motion (ROM) of the affected shoulder, the 36-item Short Form Health Survey (SF-36), and patient's self evaluation. Evaluations were performed at baseline and at 1, 2, 4, 6 months after the beginning of the treatment. Statistics will be performed after completion of treatment and follow-up.

Being tested
ESWT+PT+corticosteroid injection, ESWT group, Sham ESWT+PT+corticosteroid injection, SHAM group.
Keywords
Frozen shoulder, corticosteroid injection, physical therapy, extracorporeal shock wave therapy, rehabilitation
Medical subject headings
Bursitis

What participants receive

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

  • ESWT+PT+corticosteroid injection, ESWT groupOther

    ESWT group. Patients in the ESWT group will receive ESWT, physical therapy, and both shoulder joint (glenohumeral joint, GHJ) and SASD bursa injection for 2 times in a 2-week interval. 3ml triamcinolone (1ml triamcinolone= 10mg) will be added to 3ml 1% xylocaine to make 6ml injectate. Among them, 4ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. After withdrawing the needle to subcutaneous layer, another 2ml injectate will be injected into the SASD bursa of the affected shoulder under US guidance.

  • Sham ESWT+PT+corticosteroid injection, SHAM group.Other

    SHAM group. The participants will receive the same dosage and technique of corticosteroid posterior GHJ and SASD bursa injection for 2 times at 2 weekly interval as participants do in the ESWT group. For creating a single-blinded condition, they will also receive 4 ESWT treatments at weekly interval except that the energy flux density is set at 0.04 mJ/mm2. For sham ESWT, the machine still makes a noise with every shock wave delivered in order to enhance the sham design.

Study groups in NCT06491745
Study groupRoleWhat they receive
ESWT+PT+corticosteroid injection, ESWT groupActive comparatorESWT group. Patients in the ESWT group will receive ESWT, physical therapy, and both shoulder joint (glenohumeral joint, GHJ) and SASD bursa injection for 2 times in a 2-week interval. 3ml triamcinolone (1ml triamcinolone= 10mg) will be added to 3ml 1% xylocaine to make 6ml injectate. Among them, 4ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. After withdrawing the needle to subcutaneous layer, another 2ml injectate will be injected into the SASD bursa of the affected shoulder under US guidance.
Receives: Other: Sham ESWT+PT+corticosteroid injection, SHAM group.
Sham ESWT+PT+corticosteroid injection, SHAM group.Active comparatorSHAM group. The participants will receive the same dosage and technique of corticosteroid posterior GHJ and SASD bursa injection for 2 times at 2 weekly interval as participants do in the ESWT group. For creating a single-blinded condition, they will also receive 4 ESWT treatments at weekly interval except that the energy flux density is set at 0.04 mJ/mm2. For sham ESWT, the machine still makes a noise with every shock wave delivered in order to enhance the sham design.
Receives: Other: ESWT+PT+corticosteroid injection, ESWT group

What is being measured

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

  1. 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 (1)
  1. 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.

Timeline

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

  1. First posted9 Jul 2024
  2. Study start1 Aug 2024
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491745
Sponsor's protocol ID
20231204R
Other IDs
NSTC 113-2314-B-341-003 -, NSTC 114-2314-B-341-001 -
Status last verified
Jul 2026
First submitted
1 Jul 2024
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ESWT+PT+corticosteroid injection, ESWT group in people with Frozen Shoulder and Corticosteroid Injection, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

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 5 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Lin-Fen Hsieh (+886-28332211 ext. 2538, M001026@ms.skh.org.tw), or a site near the patient. 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?
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 7 Jul 2026.

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