Shoulder Pain Clinical Trial
— EFFECTOfficial title:
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)
NCT number | NCT05478902 |
Other study ID # | 1718862 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | May 1, 2025 |
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.
Status | Recruiting |
Enrollment | 116 |
Est. completion date | May 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Universitat de Valencia | Valencia | |
Spain | Lluis Alcanyis Hospital | Xativa | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
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. — View 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; — View 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 — View 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 E — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Baseline | |
Primary | 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). | 2 weeks | |
Primary | 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). | 4 months | |
Primary | 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). | 6 months | |
Primary | 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). | 12 months | |
Secondary | 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 | Baseline | |
Secondary | 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 | 2 weeks | |
Secondary | 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 | 4 months | |
Secondary | 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 | 6 months | |
Secondary | 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 | 12 months | |
Secondary | 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. | Baseline | |
Secondary | 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. | 4 months | |
Secondary | 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. | 12 months | |
Secondary | Type of calcification | according to the Gartner classification assessed with x-ray by an experienced radiologist | Baseline | |
Secondary | Type of calcification | according to the Gartner classification assessed with x-ray by an experienced radiologist | 4 months | |
Secondary | Type of calcification | according to the Gartner classification assessed with x-ray by an experienced radiologist | 12 months | |
Secondary | Size of the calcification | Measured in millimeters. Assessed with X-ray by an experienced radiologist | Baseline | |
Secondary | Size of the calcification | Measured in millimeters. Assessed with X-ray by an experienced radiologist | 4 months | |
Secondary | Size of the calcification | Measured in millimeters. Assessed with X-ray by an experienced radiologist | 12 months | |
Secondary | Location of the calcification | Which tendon is affected. Assessed with X-ray by an experienced radiologist | Baseline | |
Secondary | Location of the calcification | Which tendon is affected. Assessed with X-ray by an experienced radiologist | 4 months | |
Secondary | Location of the calcification | Which tendon is affected. Assessed with X-ray by an experienced radiologist | 12 months | |
Secondary | Morphology of the calcification | Isolated- fragmented - multiple. Assessed with X-ray by an experienced radiologist | Baseline | |
Secondary | Morphology of the calcification | Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist | 4 months | |
Secondary | Morphology of the calcification | Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist | 12 months | |
Secondary | Central Sensitization Inventory (CSI) | Patient-reported instrument to identify when patient's symptoms may be related to central sensitization | Baseline | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | Self-reported questionnaire for measuring the subjective perception of sleep quality | Baseline | |
Secondary | 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. | Baseline | |
Secondary | Tampa Scale for Kinesiophobia (TSK) | Self-reported questionnaire for measuring fear of movement or fear of (re)injury | Baseline | |
Secondary | 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 | Baseline | |
Secondary | Pain Catastrophizing Scale | Patient-reported outcome to measure catastrophization | Baseline | |
Secondary | EuroQoL-5D | Patient-reported outcome to measure quality of life | Baseline | |
Secondary | Hospital Anxiety and Depression Scale | Patient-reported outcome to measure psychological factors | Baseline | |
Secondary | Patient Satisfaction | Global impression of change | 2 weeks | |
Secondary | Patient Satisfaction | Global impression of change | 4 months | |
Secondary | Patient Satisfaction | Global impression of change | 6 months | |
Secondary | Patient Satisfaction | Global impression of change | 12 months | |
Secondary | 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. | Baseline | |
Secondary | 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. | 2 weeks | |
Secondary | 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. | 4 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 12 months |
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