Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490172
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-11
Brief Title:
Shock Wave Therapy As a Treatment Intervention for Frozen Shoulder
Sponsor:
University of Stirling
Organization:
University of Stirling
Study Overview
Official Title:
The Effects of Extracorporeal Shock Wave Therapy As a Treatment Intervention for Chronic Adhesive Capsulitis a Mixed Methods Pilot Study
Status:
NOT_YET_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:
Adhesive capsulitis AC is a debilitating condition that causes global restriction and pain at the glenohumeral joint Physiotherapy treatment is often first line treatment management Patients with failed conservative management are commonly referred to a specialist consultant for further treatment Over the last 20 years extracorporeal shock wave therapy ESWT has gained popularity as a treatment for various orthopaedic presentations including chronic soft tissue conditions being non-invasive resulting in good outcomes with minimal side effects There is a lack of evidence on the clinical effectiveness of ESWT for chronic AC following failed conservative treatments with the available literature reporting positive outcomes however with heterogeneity in treatment protocols This proposed study aims to explore the feasibility of a full trial of ESWT as a treatment for AC using a standardised treatment protocol and clinical effects on outcomes of pain function and shoulder joint range of movement in persons with chronic adhesive capsulitis
A Delphi study will first explore expert opinion for the optimum treatment protocol of ESWT as a treatment for chronic AC followed by a mixed methods explanatory sequential study that includes a pilot trial with nested qualitative interviews The Shoulder Pain and Disability Index numerical pain rating scale EuroQol-5D and digital goniometer will be used to measure self-reported pain and function pain health-related quality of life and shoulder joint range of movement respectively Quantitative data will be analysed by descriptive statistics Qualitative data will be collected through semi-structured interviews Interview data will be analysed using Braun and Clarkes inductive thematic analysis approach The study will be conducted in an out-patient clinical setting in a community health hub facility with patients recruited from an NHS Orthopaedics waitlist Data collection is planned over a nine month period This study is not affiliated with funding streams
A Delphi study will first explore expert opinion for the optimum treatment protocol of ESWT as a treatment for chronic AC followed by a mixed methods explanatory sequential study that includes a pilot trial with nested qualitative interviews The Shoulder Pain and Disability Index numerical pain rating scale EuroQol-5D and digital goniometer will be used to measure self-reported pain and function pain health-related quality of life and shoulder joint range of movement respectively Quantitative data will be analysed by descriptive statistics Qualitative data will be collected through semi-structured interviews Interview data will be analysed using Braun and Clarkes inductive thematic analysis approach The study will be conducted in an out-patient clinical setting in a community health hub facility with patients recruited from an NHS Orthopaedics waitlist Data collection is planned over a nine month period This study is not affiliated with funding streams
Detailed Description:
Shoulder AC commonly known as frozen shoulder is a self-limiting condition that affects three to five percent of the population and up to 20 to 30 percent in persons with diabetes mellitus Its aetiology is still being understood with evidence supporting a chronic state of low-grade inflammation and elevation of pro-inflammatory lipoproteins resulting in fibrotic changes in the glenohumeral capsule This results in pain reduced shoulder range of movement ROM and functional disability that can spontaneously resolve between one to three years with 40 percent reporting persistent symptoms at long-term follow up mean follow up time 44 years range 2 - 20 years AC can occur spontaneously as a primary insidious onset or secondary following a post-traumatic event such as shoulder surgery or rotator cuff injury Treatment for AC commonly consists of conservative management interventions including pharmacotherapy physiotherapy and corticosteroid injection with referral to secondary care if symptoms persist for interventions such as manipulation under anaesthesia and arthroscopic capsular release
The treatment interventions or surgical procedures for AC may not always be effective or suitable for all patients due to conditions that may increase risk of complications such as respiratory conditions allergies previous surgery complications co-morbidities eg liver cardiovascular and kidney disease and patient choice Untreated conditions and long-wait times can lead to chronicity further impacting an individuals health and increasing costs to the National Health Service NHS Musculoskeletal MSK conditions are estimated to cost to the British government an estimated 7 billion per year accounting for one third of the NHS budget In a United Kingdom UK health survey evaluating the prevalence of chronic pain duration of pain 12 weeks or more labelled MSK conditions as a long-lasting illness accounting for 81 percent of participants and of this 24 percent involving the shoulder Chronic MSK pain has also been linked to 175 percent of work absences anxiety depression and health inequalities
Over the last 20 years EWST has gained popularity as a treatment modality for orthopaedics conditions such as chronic tendinopathies EWST can be generated as focused high- energy 060 millijoules mjmm2 shock waves or emitted as radial low 008 mJmm2 to medium-energy 028 mJmm2 shock waves ESWT stimulates soft tissue healing via a biological response of mechanotransduction through neovascularisation reduction of tendon matrix inflammatory markers such as metalloproteinases and interleukins assists with the migration and differentiation of mesenchymal stem cells and enhances the natural healing microenvironment To date therapeutic EWST has been shown to be clinically effective to treat bone non-unions chronic soft tissue disorders such as tendinopathies and recalcitrant MSK conditions commonly involving the supraspinatus muscle tendon patellar tendon Achilles tendon and plantar fascia and has become a favourable alternative treatment for individuals who have exhausted conventional conservative interventions
A review of the literature exploring the use of ESWT as a treatment for chronic AC found seven randomised control trials RCT reporting significant improvements in function pain and shoulder ROM in groups that received ESWT The literature found improvements in all outcomes within 12 weeks when compared to a control group
Although the literature demonstrates positive outcomes due to the small number of studies small sample sizes and heterogeneity of treatment protocols there is insufficient evidence for it to be a recommended treatment for AC by national health guidelines eg National Institute for Health and Care Excellence Further research is therefore required to determine the acceptability and viability of this intervention in the UK healthcare framework with potential to conduct a full-scale RCT
The treatment interventions or surgical procedures for AC may not always be effective or suitable for all patients due to conditions that may increase risk of complications such as respiratory conditions allergies previous surgery complications co-morbidities eg liver cardiovascular and kidney disease and patient choice Untreated conditions and long-wait times can lead to chronicity further impacting an individuals health and increasing costs to the National Health Service NHS Musculoskeletal MSK conditions are estimated to cost to the British government an estimated 7 billion per year accounting for one third of the NHS budget In a United Kingdom UK health survey evaluating the prevalence of chronic pain duration of pain 12 weeks or more labelled MSK conditions as a long-lasting illness accounting for 81 percent of participants and of this 24 percent involving the shoulder Chronic MSK pain has also been linked to 175 percent of work absences anxiety depression and health inequalities
Over the last 20 years EWST has gained popularity as a treatment modality for orthopaedics conditions such as chronic tendinopathies EWST can be generated as focused high- energy 060 millijoules mjmm2 shock waves or emitted as radial low 008 mJmm2 to medium-energy 028 mJmm2 shock waves ESWT stimulates soft tissue healing via a biological response of mechanotransduction through neovascularisation reduction of tendon matrix inflammatory markers such as metalloproteinases and interleukins assists with the migration and differentiation of mesenchymal stem cells and enhances the natural healing microenvironment To date therapeutic EWST has been shown to be clinically effective to treat bone non-unions chronic soft tissue disorders such as tendinopathies and recalcitrant MSK conditions commonly involving the supraspinatus muscle tendon patellar tendon Achilles tendon and plantar fascia and has become a favourable alternative treatment for individuals who have exhausted conventional conservative interventions
A review of the literature exploring the use of ESWT as a treatment for chronic AC found seven randomised control trials RCT reporting significant improvements in function pain and shoulder ROM in groups that received ESWT The literature found improvements in all outcomes within 12 weeks when compared to a control group
Although the literature demonstrates positive outcomes due to the small number of studies small sample sizes and heterogeneity of treatment protocols there is insufficient evidence for it to be a recommended treatment for AC by national health guidelines eg National Institute for Health and Care Excellence Further research is therefore required to determine the acceptability and viability of this intervention in the UK healthcare framework with potential to conduct a full-scale RCT
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?:
False
Is an FDA AA801 Violation?:
None