Multimodal Physical Therapy With Exercise in Partial-thickness Rotator Cuff Tears

NCT ID: NCT03597490

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-05-16

Brief Summary

The aim of this study is to investigate the early stage effectiveness of multimodal physical therapy with exercise in the conservative treatment of partial thickness rotator cuff tears.

Detailed Description

Although partial thickness rotator cuff tear prevalence is greater than those of full-thickness tear, most studies on conservative treatment are associated with full-thickness tears. In general, any physical therapy modality alone is not effective in the treatment of rotator cuff tears. It has been reported that multimodal physiotherapy may be more successful than monotherapy, but evidence in this regard is inadequate. Therefore this observational prospective study aiming to investigate the effectiveness of physiotherapy in the treatment of rotator cuff tears was planned. The null hypothesis of this study is that multimodal physical therapy combined with exercise has no effect on pain and function in the treatment of partial thickness rotator cuff tears. The alternative hypothesis is the opposite.

Patients will be assessed by standardized measures in terms of pain and function (American Shoulder and Elbow Surgeons standardized shoulder form: patient self report section), active range of motion (goniometric measurement) and quality of life (Western Ontario rotator cuff index) at baseline and first, third and 6th months of follow-up.

Conditions

Partial Thickness Rotator Cuff Tear

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Partial thickness rotator cuff tear

Patients with symptomatic non-traumatic partial thickness rotator cuff tear treated with multimodal physical therapy with exercise

Multimodal physical therapy with exercise

Intervention Type: COMBINATION_PRODUCT

Multimodal physical therapy will compose of thermotherapy (hot pack or cold pack) and electrotherapy (transcutaneous electrical nerve stimulation or interferential current) and therapeutic ultrasound (at least two of them). Therapeutic exercise will compose of combination of range of motion, stretching, strengthening,neuromuscular and task specific exercises according to the clinical condition of patient under the supervision of a physiotherapist. Additionally, all patients will be allowed to carry on home exercise program.

Interventions

Multimodal physical therapy with exercise

Multimodal physical therapy will compose of thermotherapy (hot pack or cold pack) and electrotherapy (transcutaneous electrical nerve stimulation or interferential current) and therapeutic ultrasound (at least two of them). Therapeutic exercise will compose of combination of range of motion, stretching, strengthening,neuromuscular and task specific exercises according to the clinical condition of patient under the supervision of a physiotherapist. Additionally, all patients will be allowed to carry on home exercise program.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Symptomatic partial thickness rotator cuff tear verified with magnetic resonance imaging or ultrasound imaging
• Prescription of multimodal physical therapy with exercise by a clinician other than investigators prior to inclusion in the study
• Covered by the social security system
• Giving informed consent to include in the study

Exclusion Criteria

• Age of under 50
• Full thickness rotator cuff tear
• Radicular pain
• Glenohumeral osteoarthritis
• Calcific tendonitis
• Adhesive capsulitis
• History of physiotherapy in last 6 months
• Prior surgical treatment
• Contraindication to physical therapy and/or exercises

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

ilker şengül

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ilker şengül

Role: PRINCIPAL_INVESTIGATOR

İzmir Katip Çelebi University

Locations

İlker Şengül

Izmir, In the USA Or Canada, Please Select..., Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Matthewson G, Beach CJ, Nelson AA, Woodmass JM, Ono Y, Boorman RS, Lo IK, Thornton GM. Partial Thickness Rotator Cuff Tears: Current Concepts. Adv Orthop. 2015;2015:458786. doi: 10.1155/2015/458786. Epub 2015 Jun 11.

Reference Type: BACKGROUND

PMID: 26171251 (View on PubMed)

Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.

Reference Type: BACKGROUND

PMID: 27283590 (View on PubMed)

Celik D, Atalar AC, Demirhan M, Dirican A. Translation, cultural adaptation, validity and reliability of the Turkish ASES questionnaire. Knee Surg Sports Traumatol Arthrosc. 2013 Sep;21(9):2184-9. doi: 10.1007/s00167-012-2183-3. Epub 2012 Aug 30.

Reference Type: BACKGROUND

PMID: 22932692 (View on PubMed)

El O, Bircan C, Gulbahar S, Demiral Y, Sahin E, Baydar M, Kizil R, Griffin S, Akalin E. The reliability and validity of the Turkish version of the Western Ontario Rotator Cuff Index. Rheumatol Int. 2006 Oct;26(12):1101-8. doi: 10.1007/s00296-006-0151-2. Epub 2006 Jun 24.

Reference Type: BACKGROUND

PMID: 16799776 (View on PubMed)

Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003 Mar;13(2):84-92. doi: 10.1097/00042752-200303000-00004.

Reference Type: BACKGROUND

PMID: 12629425 (View on PubMed)

Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.

Reference Type: BACKGROUND

PMID: 22958838 (View on PubMed)

Other Identifiers

18.04.2018-150

Identifier Type: -

Identifier Source: org_study_id