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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
Exercise protocol for rotator cuff related shoulder pain
High Energy Extracorporeal Shockwave Therapy
Two sessions of Ultrasound-Guided Percutaneous Irrigation
Lluis Alcanyis Hospital
Xàtiva, Valencia, Spain
RECRUITINGUniversitat de Valencia
Valencia, Spain
RECRUITINGShoulder Pain And Disability Index (SPADI)
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).
Time frame: Baseline
Shoulder Pain And Disability Index (SPADI)
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).
Time frame: 2 weeks
Shoulder Pain And Disability Index (SPADI)
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).
Time frame: 4 months
Shoulder Pain And Disability Index (SPADI)
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).
Time frame: 6 months
Shoulder Pain And Disability Index (SPADI)
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).
Time frame: 12 months
Pain Intensity
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
Time frame: Baseline
Pain Intensity
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
Time frame: 2 weeks
Pain Intensity
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
Time frame: 4 months
Pain Intensity
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
Time frame: 6 months
Pain Intensity
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
Time frame: 12 months
Range of motion
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.
Time frame: Baseline
Range of motion
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.
Time frame: 4 months
Range of motion
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.
Time frame: 12 months
Type of calcification
according to the Gartner classification assessed with x-ray by an experienced radiologist
Time frame: Baseline
Type of calcification
according to the Gartner classification assessed with x-ray by an experienced radiologist
Time frame: 4 months
Type of calcification
according to the Gartner classification assessed with x-ray by an experienced radiologist
Time frame: 12 months
Size of the calcification
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Time frame: Baseline
Size of the calcification
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Time frame: 4 months
Size of the calcification
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Time frame: 12 months
Location of the calcification
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Time frame: Baseline
Location of the calcification
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Time frame: 4 months
Location of the calcification
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Time frame: 12 months
Morphology of the calcification
Isolated- fragmented - multiple. Assessed with X-ray by an experienced radiologist
Time frame: Baseline
Morphology of the calcification
Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist
Time frame: 4 months
Morphology of the calcification
Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist
Time frame: 12 months
Central Sensitization Inventory (CSI)
Patient-reported instrument to identify when patient's symptoms may be related to central sensitization
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Self-reported questionnaire for measuring the subjective perception of sleep quality
Time frame: Baseline
Fear Avoidance Beliefs Questionnaire (FABQ)
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.
Time frame: Baseline
Tampa Scale for Kinesiophobia (TSK)
Self-reported questionnaire for measuring fear of movement or fear of (re)injury
Time frame: Baseline
painDETECT Scale
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
Time frame: Baseline
Pain Catastrophizing Scale
Patient-reported outcome to measure catastrophization
Time frame: Baseline
EuroQoL-5D
Patient-reported outcome to measure quality of life
Time frame: Baseline
Hospital Anxiety and Depression Scale
Patient-reported outcome to measure psychological factors
Time frame: Baseline
Patient Satisfaction
Global impression of change
Time frame: 2 weeks
Patient Satisfaction
Global impression of change
Time frame: 4 months
Patient Satisfaction
Global impression of change
Time frame: 6 months
Patient Satisfaction
Global impression of change
Time frame: 12 months
Night Pain
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.
Time frame: Baseline
Night Pain
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.
Time frame: 2 weeks
Night Pain
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.
Time frame: 4 months
Night Pain
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.
Time frame: 6 months
Night Pain
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.
Time frame: 12 months
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