Back to resultsEffectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL) (EFFECT)
Primary Purpose
Rotator Cuff Tendinosis, Rotator Cuff Injuries, Shoulder Tendinitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise Therapy
Extracorporeal Shockwave Therapy
Ultrasound-Guided Percutaneous Irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tendinosis focused on measuring exercise therapy, lavage, rotator cuff calcific tendinopathy, shoulder calcification, extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation, shoulder pain, shape up my shoulders, sums
Eligibility Criteria
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.
Sites / Locations
- Lluis Alcanyis Hospital
- Universitat de Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
No Intervention
Arm Label
Exercise Therapy
Extracorporeal Shockwave Therapy
Ultrasound-Guided Percutaneous Irrigation
Wait and Watch group
Arm Description
This group will receive the Shape Up My Shoulders (SUMS) protocol and it will be led by a physiotherapist trained in therapeutic exercise. It will last 12 weeks and it will be divided in 3 stages. Stage I- Early-stage rehabilitation exercises (i.e., breathing and relaxation exercises, ball rolling exercises, hand gripping exercises, mental imagery and contralateral side exercises) and Shoulder Symptom Modification Procedure (SSMP). This stage typically lasts 1 to 2 weeks. Stage II - Isometric, eccentric and heavy slow resistance exercises. The final part of Stage II is a progression from eccentric only to eccentric and concentric contractions. Stage III - Functional program. This stage starts in week 5 or 6 and progressed to week 12. Involves pushing, pulling, throwing, lifting, carrying, and precision (sensory-motor control) exercises.
This group will receive high energy Extracorporeal Shockwave Therapy (ESWT) applied by an experienced physiotherapist. ESWT will be applied on the most tender point of the shoulder, located by palpation. The dose will be 1500 impulses per session without anaesthesia and an intensity between 0.15 and 0.30 mJ/mm2 depending on patient tolerance. A total of 4 treatment sessions (1 session per week) with 1 week of rest between sessions will be implemented. Patient's position during the treatment will be seated in supine position with shoulder hyperextension and internal rotation with the hand placed below the contralateral glute with the palm touching the table.
This intervention will be performed by an experienced interventionist radiologist in two sessions. The shoulder position will be with hyperextension and internal rotation with the hand behind the back. One 20 mL syringe with saline solution, one with an anaesthetic with 20 mg/mL of mepivacaine 2% and another syringe with a corticoid injection with 40 mg/mL of triamcinolone acetonide will be prepared before the intervention. Firstly, the anaesthetic will be injected directed to the calcification. Then, the procedure will consist of injecting saline solution and aspiring the calcific deposits until it is neither possible to aspire more inside the syringe nor to detect any calcifications with ultrasound imaging. After that, a corticoid will be injected to the bursa to prevent the appearance of subacromial bursitis. Finally, an anaesthetic will be injected during the extraction of the needle.
The wait and see group will not receive any intervention and will serve as a control group to determine the natural history of RCCT. If one treatment proves to be more effective then participants in the other groups will be offered that treatment after 12 months, or before, if the investigation finishes early due to an obvious group difference and a need to break randomisation codes.
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
Secondary Outcome Measures
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
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
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
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
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
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.
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.
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.
Type of calcification
according to the Gartner classification assessed with x-ray by an experienced radiologist
Type of calcification
according to the Gartner classification assessed with x-ray by an experienced radiologist
Type of calcification
according to the Gartner classification assessed with x-ray by an experienced radiologist
Size of the calcification
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Size of the calcification
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Size of the calcification
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Location of the calcification
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Location of the calcification
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Location of the calcification
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Morphology of the calcification
Isolated- fragmented - multiple. Assessed with X-ray by an experienced radiologist
Morphology of the calcification
Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist
Morphology of the calcification
Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist
Central Sensitization Inventory (CSI)
Patient-reported instrument to identify when patient's symptoms may be related to central sensitization
Pittsburgh Sleep Quality Index (PSQI)
Self-reported questionnaire for measuring the subjective perception of sleep quality
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.
Tampa Scale for Kinesiophobia (TSK)
Self-reported questionnaire for measuring fear of movement or fear of (re)injury
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
Pain Catastrophizing Scale
Patient-reported outcome to measure catastrophization
EuroQoL-5D
Patient-reported outcome to measure quality of life
Hospital Anxiety and Depression Scale
Patient-reported outcome to measure psychological factors
Patient Satisfaction
Global impression of change
Patient Satisfaction
Global impression of change
Patient Satisfaction
Global impression of change
Patient Satisfaction
Global impression of change
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05478902
Brief Title
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)
Acronym
EFFECT
Official Title
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinosis, Rotator Cuff Injuries, Shoulder Tendinitis, Calcific Shoulder Tendinitis, Calcification Tendon, Calcific Tendinitis, Shoulder Pain
Keywords
exercise therapy, lavage, rotator cuff calcific tendinopathy, shoulder calcification, extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation, shoulder pain, shape up my shoulders, sums
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Therapy
Arm Type
Experimental
Arm Description
This group will receive the Shape Up My Shoulders (SUMS) protocol and it will be led by a physiotherapist trained in therapeutic exercise. It will last 12 weeks and it will be divided in 3 stages.
Stage I- Early-stage rehabilitation exercises (i.e., breathing and relaxation exercises, ball rolling exercises, hand gripping exercises, mental imagery and contralateral side exercises) and Shoulder Symptom Modification Procedure (SSMP). This stage typically lasts 1 to 2 weeks.
Stage II - Isometric, eccentric and heavy slow resistance exercises. The final part of Stage II is a progression from eccentric only to eccentric and concentric contractions.
Stage III - Functional program. This stage starts in week 5 or 6 and progressed to week 12. Involves pushing, pulling, throwing, lifting, carrying, and precision (sensory-motor control) exercises.
Arm Title
Extracorporeal Shockwave Therapy
Arm Type
Active Comparator
Arm Description
This group will receive high energy Extracorporeal Shockwave Therapy (ESWT) applied by an experienced physiotherapist. ESWT will be applied on the most tender point of the shoulder, located by palpation. The dose will be 1500 impulses per session without anaesthesia and an intensity between 0.15 and 0.30 mJ/mm2 depending on patient tolerance. A total of 4 treatment sessions (1 session per week) with 1 week of rest between sessions will be implemented. Patient's position during the treatment will be seated in supine position with shoulder hyperextension and internal rotation with the hand placed below the contralateral glute with the palm touching the table.
Arm Title
Ultrasound-Guided Percutaneous Irrigation
Arm Type
Active Comparator
Arm Description
This intervention will be performed by an experienced interventionist radiologist in two sessions. The shoulder position will be with hyperextension and internal rotation with the hand behind the back. One 20 mL syringe with saline solution, one with an anaesthetic with 20 mg/mL of mepivacaine 2% and another syringe with a corticoid injection with 40 mg/mL of triamcinolone acetonide will be prepared before the intervention. Firstly, the anaesthetic will be injected directed to the calcification. Then, the procedure will consist of injecting saline solution and aspiring the calcific deposits until it is neither possible to aspire more inside the syringe nor to detect any calcifications with ultrasound imaging. After that, a corticoid will be injected to the bursa to prevent the appearance of subacromial bursitis. Finally, an anaesthetic will be injected during the extraction of the needle.
Arm Title
Wait and Watch group
Arm Type
No Intervention
Arm Description
The wait and see group will not receive any intervention and will serve as a control group to determine the natural history of RCCT. If one treatment proves to be more effective then participants in the other groups will be offered that treatment after 12 months, or before, if the investigation finishes early due to an obvious group difference and a need to break randomisation codes.
Intervention Type
Procedure
Intervention Name(s)
Exercise Therapy
Other Intervention Name(s)
Shape Up My Shoulders Protocol
Intervention Description
Exercise protocol for rotator cuff related shoulder pain
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shockwave Therapy
Intervention Description
High Energy Extracorporeal Shockwave Therapy
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-Guided Percutaneous Irrigation
Other Intervention Name(s)
Lavage
Intervention Description
Two sessions of Ultrasound-Guided Percutaneous Irrigation
Primary Outcome Measure Information:
Title
Shoulder Pain And Disability Index (SPADI)
Description
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
Title
Shoulder Pain And Disability Index (SPADI)
Description
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
Title
Shoulder Pain And Disability Index (SPADI)
Description
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
Title
Shoulder Pain And Disability Index (SPADI)
Description
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
Title
Shoulder Pain And Disability Index (SPADI)
Description
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
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
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
Title
Pain Intensity
Description
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
Title
Pain Intensity
Description
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
Title
Pain Intensity
Description
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
Title
Pain Intensity
Description
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
Title
Range of motion
Description
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
Title
Range of motion
Description
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
Title
Range of motion
Description
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
Title
Type of calcification
Description
according to the Gartner classification assessed with x-ray by an experienced radiologist
Time Frame
Baseline
Title
Type of calcification
Description
according to the Gartner classification assessed with x-ray by an experienced radiologist
Time Frame
4 months
Title
Type of calcification
Description
according to the Gartner classification assessed with x-ray by an experienced radiologist
Time Frame
12 months
Title
Size of the calcification
Description
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Time Frame
Baseline
Title
Size of the calcification
Description
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Time Frame
4 months
Title
Size of the calcification
Description
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Time Frame
12 months
Title
Location of the calcification
Description
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Time Frame
Baseline
Title
Location of the calcification
Description
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Time Frame
4 months
Title
Location of the calcification
Description
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Time Frame
12 months
Title
Morphology of the calcification
Description
Isolated- fragmented - multiple. Assessed with X-ray by an experienced radiologist
Time Frame
Baseline
Title
Morphology of the calcification
Description
Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist
Time Frame
4 months
Title
Morphology of the calcification
Description
Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist
Time Frame
12 months
Title
Central Sensitization Inventory (CSI)
Description
Patient-reported instrument to identify when patient's symptoms may be related to central sensitization
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Self-reported questionnaire for measuring the subjective perception of sleep quality
Time Frame
Baseline
Title
Fear Avoidance Beliefs Questionnaire (FABQ)
Description
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
Title
Tampa Scale for Kinesiophobia (TSK)
Description
Self-reported questionnaire for measuring fear of movement or fear of (re)injury
Time Frame
Baseline
Title
painDETECT Scale
Description
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
Title
Pain Catastrophizing Scale
Description
Patient-reported outcome to measure catastrophization
Time Frame
Baseline
Title
EuroQoL-5D
Description
Patient-reported outcome to measure quality of life
Time Frame
Baseline
Title
Hospital Anxiety and Depression Scale
Description
Patient-reported outcome to measure psychological factors
Time Frame
Baseline
Title
Patient Satisfaction
Description
Global impression of change
Time Frame
2 weeks
Title
Patient Satisfaction
Description
Global impression of change
Time Frame
4 months
Title
Patient Satisfaction
Description
Global impression of change
Time Frame
6 months
Title
Patient Satisfaction
Description
Global impression of change
Time Frame
12 months
Title
Night Pain
Description
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
Title
Night Pain
Description
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
Title
Night Pain
Description
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
Title
Night Pain
Description
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
Title
Night Pain
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lirios Dueñas, PT, PhD
Phone
0034655525373
Email
liriosclinic@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Iván Caballero, PT, MSc
Phone
0034649109143
Email
ivancaballerofisioterapia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Lluch, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Director
Facility Information:
Facility Name
Lluis Alcanyis Hospital
City
Xativa
State/Province
Valencia
ZIP/Postal Code
46800
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Gallego, MD
Phone
691870052
Ext
+34
Email
crisgallegoterres@gmail.com
First Name & Middle Initial & Last Name & Degree
Cristina Gallego-Terres, MD
First Name & Middle Initial & Last Name & Degree
Luis Bresó-Parra, MD
Facility Name
Universitat de Valencia
City
Valencia
ZIP/Postal Code
46020
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lirios Dueñas Moscardó, PhD
Phone
0034655525373
Email
liriosclinic@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30774461
Citation
Sansone V, Maiorano E, Galluzzo A, Pascale V. Calcific tendinopathy of the shoulder: clinical perspectives into the mechanisms, pathogenesis, and treatment. Orthop Res Rev. 2018 Oct 3;10:63-72. doi: 10.2147/ORR.S138225. eCollection 2018.
Results Reference
result
PubMed Identifier
32830280
Citation
Simpson M, Pizzari T, Cook T, Wildman S, Lewis J. Effectiveness of non-surgical interventions for rotator cuff calcific tendinopathy: A systematic review. J Rehabil Med. 2020 Oct 31;52(10):jrm00119. doi: 10.2340/16501977-2725.
Results Reference
result
PubMed Identifier
17188907
Citation
Harvie P, Pollard TC, Carr AJ. Calcific tendinitis: natural history and association with endocrine disorders. J Shoulder Elbow Surg. 2007 Mar-Apr;16(2):169-73. doi: 10.1016/j.jse.2006.06.007. Epub 2006 Dec 22.
Results Reference
result
PubMed Identifier
25870115
Citation
Louwerens JK, Sierevelt IN, van Hove RP, van den Bekerom MP, van Noort A. Prevalence of calcific deposits within the rotator cuff tendons in adults with and without subacromial pain syndrome: clinical and radiologic analysis of 1219 patients. J Shoulder Elbow Surg. 2015 Oct;24(10):1588-93. doi: 10.1016/j.jse.2015.02.024. Epub 2015 Apr 11.
Results Reference
result
PubMed Identifier
10797220
Citation
Uhthoff HK, Loehr JW. Calcific Tendinopathy of the Rotator Cuff: Pathogenesis, Diagnosis, and Management. J Am Acad Orthop Surg. 1997 Jul;5(4):183-191. doi: 10.5435/00124635-199707000-00001.
Results Reference
result
PubMed Identifier
22745199
Citation
Ioppolo F, Tattoli M, Di Sante L, Attanasi C, Venditto T, Servidio M, Cacchio A, Santilli V. Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels. Phys Ther. 2012 Nov;92(11):1376-85. doi: 10.2522/ptj.20110252. Epub 2012 Jun 28.
Results Reference
result
PubMed Identifier
31191964
Citation
Lafrance S, Doiron-Cadrin P, Saulnier M, Lamontagne M, Bureau NJ, Dyer JO, Roy JS, Desmeules F. Is ultrasound-guided lavage an effective intervention for rotator cuff calcific tendinopathy? A systematic review with a meta-analysis of randomised controlled trials. BMJ Open Sport Exerc Med. 2019 Mar 9;5(1):e000506. doi: 10.1136/bmjsem-2018-000506. eCollection 2019.
Results Reference
result
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Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)
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