Shock Wave Therapy as a Treatment Intervention for Frozen Shoulder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Stirling
About this trial
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 Clarke's 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants aged 18 years and older.
Diagnosis of primary or secondary shoulder AC of a greater than three-month duration.
Diagnosis of AC by an orthopaedic consultant or upper limb Advanced Practice Physiotherapist.
Participants can attend an outpatient rural physiotherapy department to receive shockwave therapy intervention.
Disqualifiers
Participants who have bilateral shoulder pain, capsular tightness, calcific rotator cuff tendinitis, rotator cuff tear (atraumatic or traumatic), previous surgery on the affected shoulder, shoulder fracture, dislocation or subluxation, glenohumeral or acromioclavicular arthritis, malignancy, inflammatory disorders, neuromuscular disorders, presence of severe osteoporosis, pulmonary diseases, implanted pacemaker and pregnancy.
They have conditions related to ESWT contraindications (e.g., pregnancy, pacemaker, metal work or joint replacement near the treatment site, blood clotting disorder, use of anti-coagulants, less than six weeks of receiving a steroid injection over treatment site, malignancy, local infection or open wounds, skeletal growth places, under 18 years old).
Symptom duration less than 12 weeks.
Absent or altered skin sensation.
Trial design
Design model
Sequential
Treatments tested in this trial
Shock wave therapy
DeviceRadial Extracorporeal Shock Wave Therapy and feasibility as treatment for adhesive capsulitis
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: Delphi StudyNo intervention 0 interventions
Group B: Shock wave therapy quantitative data collection and analysisExperimental treatment 1 intervention
Group C: Qualitative semi-structured interviewsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment and rejection rate
Estimate the proportion of patients screened who meet the eligibility criteria. This will be analysed with descriptive statistics using IBM SPSS Statistical Software. This will be displayed as a numerical value with standard deviation
Time frame
18 months2
Retention rate
Adherence and compliance to intervention and home exercise programme, follow-up and drops out. This will be analysed with descriptive statistics using IBM SPSS Statistical Software. This will be displayed as a numerical value with standard deviation
Time frame
18 monthSecondary outcomes
1
The Shoulder Pain and Disability Index
Self-reported pain and function in shoulder conditions. 13 item questionnaire that assesses two domains, pain and disability, that best represents their shoulder symptoms over a week. The scale is scored from a zero, 'no pain / no difficulty,' to 10, 'worst pain imaginable / so difficult requires help', with higher scores indicating increase impairment or disability, and can be used to monitor change over time. A difference of eight points is the minimal detectable change for clinical significance.
Time frame
0, 6, and 12 weeks.2
Numerical Pain Rating Scale
One-dimensional tool used to measure pain both at rest and during movement. It is a 11-point scale for self-reported pain, zero meaning 'no pain' to 10 'extreme pain / worse pain possible,' at the time the questionnaire is administered and has been found to be more versatile being delivered in both verbal and written formats. Minimal clinical difference of change sore for general conditions is 3.0cm, and rotator cuff pain is 1.4cm on scale.
Time frame
0, 6, and 12 weeks.3
EuroQoL-5D-5L
Questionnaire measuring health-related quality of life. It measures five dimensions of health, mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, on a five-level scale. A score of one across all five categories represents the best possible health, whereas a score of five across all five categories represents the worst health status. The EQ-5D-5L also includes a perceived health status demonstrated as a visual analogue scale with grade ranging from zero, the worst possible health status, to 100, the best possible health status.
Time frame
0, 6, and 12 weeks.4
Digital Goniometry
A digital goniometer or smart phone application digital inclinometer will be used to measure shoulder joint passive ROM.
Time frame
0, 6, and 12 weeks.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: