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

NCT03597490 | Terminated

• 1 other identifier: 18.04.2018-150
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Thickness Rotator Cuff Tear

Keywords

Partial Thickness Rotator Cuff Tear; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Pain/function

  Pain and function are assessed by Turkish version of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section. It consists of two subscales including pain (one item) and function section (ten items). Pain and function subscales range between 0 and 50 with a maximum total score of 100. Lower pain subscale score means more pain, and lower function subscale score means more functional loss. The Turkish version of ASES standardized shoulder form:patient self reported section has been reported as reliable and valid.

  Baseline to 6 months follow-up

Secondary Outcomes (1)

• Disease specific health-related quality of life

  Baseline to 6 months follow-up

Other Outcomes (1)

• Active range of motion of shoulder joint

  Baseline to 6 months follow-up

Study Arms (1)

Partial thickness rotator cuff tear

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

Combination Product: Multimodal physical therapy with exercise

Interventions

Multimodal physical therapy with exercise 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.

Partial thickness rotator cuff tear

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic nontraumatic partial thickness rotator cuff tear

You may qualify if:

• Symptomatic partial thickness rotator cuff tear verified with magnetic resonance imaging or ultrasound imaging
• Covered by the social security system
• Giving informed consent to include in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İlker Şengül

Izmir, In the USA Or Canada, Please Select..., 35360, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 26171251 BACKGROUND

• 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.

  PMID: 27283590 BACKGROUND

• 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.

  PMID: 22932692 BACKGROUND

• 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.

  PMID: 16799776 BACKGROUND

• 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.

  PMID: 12629425 BACKGROUND

• 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.

  PMID: 22958838 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• ilker şengül

  İzmir Katip Çelebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 24, 2018
• Study Start: July 1, 2018
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)