Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491745
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder
Sponsor:
Shin Kong Wu Ho-Su Memorial Hospital
Organization:
Shin Kong Wu Ho-Su Memorial Hospital
Study Overview
Official Title:
Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 134
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 subacromialsubdeltoid 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 Dupuytrens 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
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 subacromialsubdeltoid 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 Dupuytrens 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
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NSTC 113-2314-B-341-003 - | OTHER_GRANT | None | None |