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Partial Thickness Rotator Cuff TearNCT03597490

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

An observational study of Partial Thickness Rotator Cuff Tear, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Partial Thickness Rotator Cuff Tear
What is being tested?
Multimodal physical therapy with exercise
How many people
3 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2018to 16 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with symptomatic nontraumatic partial thickness rotator cuff tear

Who may be able to join

  • 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

Who cannot join

  • Age of under 50
  • Full thickness rotator cuff tear
  • Radicular pain
  • Glenohumeral osteoarthritis
  • Calcific tendonitis
  • Adhesive capsulitis
Show all 9Show fewer
  • History of physiotherapy in last 6 months
  • Prior surgical treatment
  • Contraindication to physical therapy and/or exercises

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • İlker Şengül

    Izmir, In the USA Or Canada, Please Select..., 35360

Other trials in Turkey (Türkiye)

About this study

Official title: Effectiveness of Multimodal Physical Therapy Combined With Exercise in Partial-thickness Rotator Cuff Tears: a Prospective Observational Study

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.

Read the 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.

Being tested
Multimodal physical therapy with exercise
Keywords
Partial Thickness Rotator Cuff Tear, Physical Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal physical therapy with exerciseCombination 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.

Study groups in NCT03597490
Study groupRoleWhat they receive
Partial thickness rotator cuff tearPatients with symptomatic non-traumatic partial thickness rotator cuff tear treated with multimodal physical therapy with exercise
Receives: Combination Product: Multimodal physical therapy with exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 6 months follow-up

Secondary outcomes (1)

  1. Disease specific health-related quality of life

    Disease specific health-related quality of life is assessed by Turkish version of Western Ontario Rotator Cuff Index.The Turkish version of the WORC index has been found a reliable and valid measurement tool. WORC index consists of 5 subscales including physical symptoms (6 items), sports and recreation (4 items), work (4 items), life style (4 items) and emotions (3 items). Each item is estimated based on 0-100 mm visual analogue scale. By summating the item scores, subscale scores and total scores are computed (possible total maximum score is 2100). Lower scores represents higher quality of life.

    Measured: Baseline to 6 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2018
  2. Study start1 Jul 2018
  3. Primary completion16 May 2019
  4. Study completion16 May 2019

Why it stopped: excessive dropout

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03597490
Sponsor's protocol ID
18.04.2018-150
Status last verified
May 2019
First submitted
2 Jul 2018
Last updated
20 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26171251

  • 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.

    PubMed 27283590

  • 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.

    PubMed 22932692

  • 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.

    PubMed 16799776

  • 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.

    PubMed 12629425

  • 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.

    PubMed 22958838

Questions about this trial

What is this clinical trial studying?

An observational study of Partial Thickness Rotator Cuff Tear, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: excessive dropout). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain/function (time frame: Baseline to 6 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03597490, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.

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