Clinical trial NCT05478902: Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)
Official title: Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Shoulder Pain And Disability Index (SPADI)
timeFrame: Baseline
measure: Shoulder Pain And Disability Index (SPADI)
timeFrame: 2 weeks
measure: Shoulder Pain And Disability Index (SPADI)
timeFrame: 4 months
measure: Shoulder Pain And Disability Index (SPADI)
timeFrame: 6 months
measure: Shoulder Pain And Disability Index (SPADI)
timeFrame: 12 months
Secondary outcomes:
measure: Pain Intensity
timeFrame: Baseline
measure: Pain Intensity
timeFrame: 2 weeks
measure: Pain Intensity
timeFrame: 4 months
measure: Pain Intensity
timeFrame: 6 months
measure: Pain Intensity
timeFrame: 12 months
measure: Range of motion
timeFrame: Baseline
measure: Range of motion
timeFrame: 4 months
measure: Range of motion
timeFrame: 12 months
measure: Type of calcification
timeFrame: Baseline
measure: Type of calcification
timeFrame: 4 months
measure: Type of calcification
timeFrame: 12 months
measure: Size of the calcification
timeFrame: Baseline
measure: Size of the calcification
timeFrame: 4 months
measure: Size of the calcification
timeFrame: 12 months
measure: Location of the calcification
timeFrame: Baseline
measure: Location of the calcification
timeFrame: 4 months
measure: Location of the calcification
timeFrame: 12 months
measure: Morphology of the calcification
timeFrame: Baseline
measure: Morphology of the calcification
timeFrame: 4 months
measure: Morphology of the calcification
timeFrame: 12 months
measure: Central Sensitization Inventory (CSI)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Baseline
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline
measure: painDETECT Scale
timeFrame: Baseline
measure: Pain Catastrophizing Scale
timeFrame: Baseline
measure: EuroQoL-5D
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Patient Satisfaction
timeFrame: 2 weeks
measure: Patient Satisfaction
timeFrame: 4 months
measure: Patient Satisfaction
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 12 months
measure: Night Pain
timeFrame: Baseline
measure: Night Pain
timeFrame: 2 weeks
measure: Night Pain
timeFrame: 4 months
measure: Night Pain
timeFrame: 6 months
measure: Night Pain
timeFrame: 12 months
Other outcomes:
Locations:
city: Xativa
country: Spain
facility: Lluis Alcanyis Hospital
state: Valencia
city: Valencia
country: Spain
facility: Universitat de Valencia
Study officials:
affiliation: University of Valencia
name: Enrique Lluch, PT, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.