Calcification Tendon, Calcific Shoulder Tendinitis, Calcific Tendinitis, Rotator Cuff Injuries, Rotator Cuff Tendinosis, Shoulder Pain, Shoulder Tendinitis
Conditions
Keywords
exercise therapy, lavage, rotator cuff calcific tendinopathy, shoulder calcification, extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation, shoulder pain, shape up my shoulders, sums
Brief summary
The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.
Detailed description
Rotator cuff calcific tendinopathy (RCCT) is a common musculoskeletal disorder caused by the presence of calcific deposits in the rotator cuff with an important impact in the quality of life of those who are suffering it. Conservative interventions such as extracorporeal shockwave therapy (ESWT) or ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) have been commonly recommended as part of the early management for this clinical condition. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been tested in people with RCCT yet. A randomised, single-blinded four parallel group clinical trial will be conducted. Participants (n=116) will be randomised in four groups: (1) ET; (2) ESWT; (3) US-PICT or (4) control.
Interventions
PROCEDUREExercise Therapy
Exercise protocol for rotator cuff related shoulder pain
PROCEDUREExtracorporeal Shockwave Therapy
High Energy Extracorporeal Shockwave Therapy
PROCEDUREUltrasound-Guided Percutaneous Irrigation
Two sessions of Ultrasound-Guided Percutaneous Irrigation
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* calcification deposit in the rotator cuff confirmed by diagnostic imaging (ultrasound, MRI or X-ray); * pain and loss of function in the shoulder; * not currently receiving physiotherapy or ESWT.
Exclusion criteria
* previous treatments on last year (e.g., injections, ESWT, US-PICT, surgery, etc.); * other shoulder disorders or trauma (e.g., fractures, dislocations, rotator cuff tears, frozen shoulder or shoulder instability); * known allergy to any of the pharmacological products used in the study; * taking oral anticoagulants * taking oral steroid within the six months prior to participation in the study; * cancer, systemic disease, pregnancy or infection; * neck pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain And Disability Index (SPADI) | Baseline | Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline | Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back |
| Range of motion | Baseline | Flexion, abduction and hand behind the back measured with a questionnaire with different stages. Degrees measured in different stages ranged from 0-30º, 30-60º, 60-90º, 90-120º, 120-150º and above 150º for flexion and abduction. For hand behind the back: hand to the hip, to the buttock, low back, mid back or between scapulas. |
| Type of calcification | Baseline | according to the Gartner classification assessed with x-ray by an experienced radiologist |
| Size of the calcification | Baseline | Measured in millimeters. Assessed with X-ray by an experienced radiologist |
| Location of the calcification | Baseline | Which tendon is affected. Assessed with X-ray by an experienced radiologist |
| Morphology of the calcification | Baseline | Isolated- fragmented - multiple. Assessed with X-ray by an experienced radiologist |
| Central Sensitization Inventory (CSI) | Baseline | Patient-reported instrument to identify when patient's symptoms may be related to central sensitization |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline | Self-reported questionnaire for measuring the subjective perception of sleep quality |
| Fear Avoidance Beliefs Questionnaire (FABQ) | Baseline | Patient-reported instrument for measuring fear avoidance and beliefs. The score range is 0 to 96, with a higher value reflecting a higher degree of fear avoidance beliefs. |
| Tampa Scale for Kinesiophobia (TSK) | Baseline | Self-reported questionnaire for measuring fear of movement or fear of (re)injury |
| painDETECT Scale | Baseline | Self-administered questionnaire, developed to quickly detect neuropathic pain, asking the patient about the pain experienced at the moment and with- in the last 4 weeks |
| Pain Catastrophizing Scale | Baseline | Patient-reported outcome to measure catastrophization |
| EuroQoL-5D | Baseline | Patient-reported outcome to measure quality of life |
| Hospital Anxiety and Depression Scale | Baseline | Patient-reported outcome to measure psychological factors |
| Patient Satisfaction | 2 weeks | Global impression of change |
| Night Pain | Baseline | How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night. |
Countries
Spain
Contacts
STUDY_DIRECTOREnrique Lluch, PT, PhD
University of Valencia
Outcome results
None listed