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

NCT06491745 | Recruiting DMC

• 3 other identifiers: 20231204RNSTC 113-2314-B-341-003 -NSTC 114-2314-B-341-001 -
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Frozen Shoulder; Corticosteroid Injection; Physical Therapy; Extracorporeal Shock Wave Therapy; Rehabilitation

Keywords

Frozen shoulder; corticosteroid injection; physical therapy; extracorporeal shock wave therapy; rehabilitation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• The pain visual analog scale (VAS)

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

Other Outcomes (4)

• Range of motion（ROM）

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

• Shoulder Disability Questionnaire（SDQ）

  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）

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

Study Arms (2)

ESWT+PT+corticosteroid injection, ESWT group

ACTIVE COMPARATOR

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.

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

Sham ESWT+PT+corticosteroid injection, SHAM group.

ACTIVE COMPARATOR

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.

Other: ESWT+PT+corticosteroid injection, ESWT group

Interventions

ESWT+PT+corticosteroid injection, ESWT group OTHER

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.

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.

ESWT+PT+corticosteroid injection, ESWT group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Lin-Fen Hsieh

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin-Fen Hsieh

CONTACT

+886-28332211; M001026@ms.skh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

TW (1)