The Effectiveness of Therapeutic Ultrasound in the Treatment of Calcific Tendinitis of the Shoulder

NCT04822779 | Unknown

• 1 other identifier: UHC Zagreb
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Rotator cuff tendinitis (RCT) has a prevalence between 2.7 and 22%, and predominantly affects middle-aged women. The pathophysiology has not been fully elucidated to date. RCT is characterized by hydroxyapatite crystal deposition in the rotator cuff tendons. Approximately half of the patients with RCT have pain with acute or chronic shoulder mobility limitation. In some patients, RCT shows a tendency for spontaneous and rapid regression. Diagnostic ultrasound (D-US) is a non-invasive, non-ionizing, and relatively inexpensive diagnostic imaging method that is safe and reliable in assessing rotator cuff pathology. It is very sensitive in the identification of calcifications that are shown in grayscale (B-mode) as hyperechoic structures with or without acoustic shadow. Based on ultrasound findings, Chiou HJ et al. have classified calcifications into 4 types: type I are arcuate, type II are fragmented or punctiform, type III are nodular, and type IV are cystic. Spontaneous resorption may occur with type III and IV calcifications. A positive Doppler signal (PD) surrounding the calcification is highly correlated with pain intensity. According to the European Union of Medical Specialists-Physical and Rehabilitation Medicine (UEMS-PRM) guidelines, the basis of RCT therapy is individual medical gymnastics (IMG). It includes exercises aimed to restore full shoulder mobility, and improve rotator cuff and scapular stabilizer muscles strength. Other passive procedures are elective in the choice of treatment. Ultrasound therapy is often used in the treatment of musculoskeletal shoulder pathology due to its thermal and non-thermal effects. It is considered that tissue heating stimulates healing (vasodilation, acceleration of the metabolism, and improvement of the viscoelastic properties of the connective tissue). The frequency of ultrasound therapy is selected depending on the desired depth of action (3 MHz for surface structures up to 2.5 cm depth, and 1 MHz for deeper structures, up to 5 cm depth). Pulse mode is commonly used in acute, while continuous in chronic conditions. To date, only a few studies have evaluated the reduction in calcification size after ultrasound therapy. Although ultrasound therapy is routinely used in the treatment of painful shoulder, reviewing the results of research published so far, we can say that current knowledge about the effectiveness of ultrasound therapy in RCT is inconsistent (only several studies with a small number of subjects, different parameters of applied ultrasound therapy in terms of penetration depth, applied energy and duration of treatment). This indicates the need for further research.

Conditions

Rotator Cuff Tendinitis; Shoulder Pain; Musculoskeletal Diseases

Keywords

ultrasound therapy; rehabilitation; kinesiotherapy; diagnostic ultrasound

Outcome Measures

Primary Outcomes (1)

• The change in calcification size measured by D-ultrasound before and after the intervention.

  The researcher will perform an ultrasound examination of the shoulder immediately before and immediately after the therapeutic intervention. The size of the calcification will be measured according to the standard size measurement protocol, and another examiner will make an independent measurement. The final measure will take the average value of the two.

  4 weeks

Secondary Outcomes (4)

• To compare the effectiveness of therapeutic ultrasound in combination with individual medical gymnastics with the effectiveness of individual medical gymnastics in reducing pain.

  4 weeks

• To compare the effectiveness of therapeutic ultrasound in combination with individual medical gymnastics with the effectiveness of individual medical gymnastics on increasing shoulder mobility.

  4 weeks

• To compare the effectiveness of therapeutic ultrasound in combination with individual medical gymnastics with the effectiveness of individual medical gymnastics on improving the functional status of the shoulder.

  4 weeks

• To compare the effectiveness of therapeutic ultrasound in combination with individual medical gymnastics with the effectiveness of individual medical gymnastics on the overall satisfaction with the outcome of rehabilitation.

  4 weeks

Study Arms (2)

Active Group

ACTIVE COMPARATOR

This group will receive ultrasound therapy. Respondents will conduct individual medical-gymnastics: unloading pendular exercises if strength exercises cannot be started immediately, shoulder range exercises, and rotator cuff and scapula stabilizer exercises for 30 minutes per treatment.

Device: Sonopuls 490u, Enraf-Nonius, Rotterdam, Kingdom of the Netherlands

Control Group

SHAM COMPARATOR

This group will receive sham ultrasound therapy. Respondents will conduct the same individual medical-gymnastics, as in the active group: unloading pendular exercises if strength exercises cannot be started immediately, shoulder range exercises, and rotator cuff and scapula stabilizer exercises for 30 minutes per treatment.

Other: Placebo

Interventions

Sonopuls 490u, Enraf-Nonius, Rotterdam, Kingdom of the Netherlands DEVICE

Ultrasound therapy will be applied in continuous output, 1 MHz frequency, the intensity of 1.5 W / cm2, and duration 10 min per treatment, on the front of the shoulder, on the surface of 2 ultrasound heads (10 cm2). The position of the arm will be in adduction and internal rotation in RCT of the supraspinatus, adduction and external rotation of the arm in RCT of the subscapularis, and the position of the arm over the opposite shoulder in RCT of the infraspinatus.

Active Group

Placebo OTHER

Sham ultrasound therapy will be applied using a frequency of 0 Hz, intensity 0 W / cm2, 10 min per treatment. The position of the arm will be in adduction and internal rotation in RCT of the supraspinatus, adduction and external rotation of the arm in RCT of the subscapularis, and the position of the arm over the opposite shoulder in RCT of the infraspinatus.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic RCT (VAS pain ≥ 4 + limited shoulder mobility) with D-ultrasound calcification size ≥ 5 mm
• calcification type I and II according to Chiou HJ et al.
• disease duration ≥ 2 months

You may not qualify if:

• asymptomatic RCT or RCT with mild symptoms (VAS pain ≤ 3 + normal shoulder mobility)
• calcification size \< 5 mm, type III and IV calcification according to Chiou HJ et al.
• duration symptoms less than 2 months
• rotator cuff tendon rupture
• adhesive capsulitis
• application of corticosteroids in the examined shoulder in the previous 3 months
• glucocorticoid therapy
• physical shoulder therapy in the previous 6 months
• shock wave therapy in the previous 12 months
• prior percutaneous calcification irrigation
• current cervical or cervicobrachial pain syndrome
• inflammatory rheumatic disease
• scapular dyskinesia with positive assisted and repository scapular test
• subacromial/subdeltoid bursitis
• recent trauma or malignancy

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

University Department for Rheumatology and Rehabilitation, Clinical Hospital Centre Zagre

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Related Publications (6)

• Chiou HJ, Chou YH, Wu JJ, Hsu CC, Huang DY, Chang CY. Evaluation of calcific tendonitis of the rotator cuff: role of color Doppler ultrasonography. J Ultrasound Med. 2002 Mar;21(3):289-95; quiz 296-7. doi: 10.7863/jum.2002.21.3.289.

  PMID: 11883540 BACKGROUND

• Varela E, Valero R, Kucukdeveci AA, Oral A, Ilieva E, Berteanu M, Christodoulou N; UEMS-PRM Section Professional Practice Committee. Shoulder pain management. The role of physical and rehabilitation medicine physicians. The European perspective based on the best evidence. A paper by the UEMS-PRM Section Professional Practice Committee. Eur J Phys Rehabil Med. 2013 Oct;49(5):743-51.

  PMID: 24145232 BACKGROUND

• Alexander LD, Gilman DR, Brown DR, Brown JL, Houghton PE. Exposure to low amounts of ultrasound energy does not improve soft tissue shoulder pathology: a systematic review. Phys Ther. 2010 Jan;90(1):14-25. doi: 10.2522/ptj.20080272. Epub 2009 Nov 12.

  PMID: 19910457 BACKGROUND

• Ebenbichler GR, Erdogmus CB, Resch KL, Funovics MA, Kainberger F, Barisani G, Aringer M, Nicolakis P, Wiesinger GF, Baghestanian M, Preisinger E, Fialka-Moser V. Ultrasound therapy for calcific tendinitis of the shoulder. N Engl J Med. 1999 May 20;340(20):1533-8. doi: 10.1056/NEJM199905203402002.

  PMID: 10332014 BACKGROUND

• Williams JW Jr, Holleman DR Jr, Simel DL. Measuring shoulder function with the Shoulder Pain and Disability Index. J Rheumatol. 1995 Apr;22(4):727-32.

  PMID: 7791172 BACKGROUND

• Philadelphia Panel. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for shoulder pain. Phys Ther. 2001 Oct;81(10):1719-30.

  PMID: 11589645 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stjepan Čota, MD

CONTACT

+385917683917; stjepancota@yahoo.com

Nadica Laktašić Žerjavić, Assist. Prof.

CONTACT

nadica_laktasic@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization of patients will be performed before the intervention in the R software package and the results of the randomization will be known only to the therapist who will be involved in the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stjepan Čota, MD

Model Details: The research will be a double-blind randomized control prospective study.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: January 1, 2023
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CR (1)