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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06006351
Other study ID # Uskudar54
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 1, 2023

Study information

Verified date December 2023
Source Uskudar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the effects of exercise and Hypervolt Device on pain, muscle strength and normal joint movement in the treatment of shoulder impingement syndrome.


Description:

The study was planned as a randomized controlled trial. The study sample will be divided into two groups by simple randomization method. Only exercise will be applied to 30 individuals diagnosed with shoulder impingement in the first group of the study. In the second group, 30 individuals with shoulder impingement diagnosis will be given a Hypervolt Device in addition to the exercise. Disabilities of the Arm, Shoulder and Hand Questionnaire, Visual Analog Scale and Lawton Daily Living Activities Questionnaire will be applied to the participants before and after the treatment. The obtained data will be analyzed statistically.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Being between the ages of 18-50. - Having a Visual Analogue Scale (VAS) value of 5 or higher. - Having a history of shoulder pain for at least 1 month. - Volunteer to participate in research. - Having been diagnosed with Shoulder Impingement. Exclusion Criteria: - Having cognitive, mental or psychological problems. - Having a condition that prevents him from exercising.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapy
manual therapy stretching exercises strengthening exercises electrotherapy applications
Hypervolt Device
The painful area will be applied with a massage tool, and the frequency and mode of the tool will be adjusted in a way that does not disturb the patient.

Locations

Country Name City State
Turkey Uskudar university Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Consigliere P, Haddo O, Levy O, Sforza G. Subacromial impingement syndrome: management challenges. Orthop Res Rev. 2018 Oct 23;10:83-91. doi: 10.2147/ORR.S157864. eCollection 2018. — View Citation

Ellenbecker TS, Cools A. Rehabilitation of shoulder impingement syndrome and rotator cuff injuries: an evidence-based review. Br J Sports Med. 2010 Apr;44(5):319-27. doi: 10.1136/bjsm.2009.058875. — View Citation

Gebremariam L, Hay EM, van der Sande R, Rinkel WD, Koes BW, Huisstede BM. Subacromial impingement syndrome--effectiveness of physiotherapy and manual therapy. Br J Sports Med. 2014 Aug;48(16):1202-8. doi: 10.1136/bjsports-2012-091802. Epub 2013 Nov 11. — View Citation

Marik TL, Roll SC. Effectiveness of Occupational Therapy Interventions for Musculoskeletal Shoulder Conditions: A Systematic Review. Am J Occup Ther. 2017 Jan/Feb;71(1):7101180020p1-7101180020p11. doi: 10.5014/ajot.2017.023127. — View Citation

Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disabilities of the Arm, Shoulder and Hand Questionnaire It was developed to evaluate functional status and symptoms by focusing on physical function in upper extremity injuries. According to the results of the survey; a result from 0-100 is obtained from each part; 0-no apology 100-maximum apology. 12 weeks
Primary Lawton Activities of Daily Living Scale It is a questionnaire consisting of eight questions, including information about using the telephone, preparing food, shopping, doing daily household chores, washing clothes, getting on a transportation vehicle, using medicines and managing money. If the individual does the activities independently, three points, two points if he does it with help, and one point if he cannot do it at all. In Lawton Activities of Daily Living Scale; 0-8 points are classified as "dependent", 9-16 points as "semi-dependent", 17-24 points as "independent". 12 weeks
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