NCT06006351

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

August 17, 2023

Last Update Submit

December 21, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

control

ACTIVE COMPARATOR

classical physiotherapy protocol will be applied.

Other: Physiotherapy

Massage

EXPERIMENTAL

In addition to the classical physiotherapy protocol, a Hypervolt Device will be applied.

Other: PhysiotherapyOther: Hypervolt Device

Interventions

manual therapy stretching exercises strengthening exercises electrotherapy applications

Massagecontrol

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.

Massage

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Having cognitive, mental or psychological problems.
  • Having a condition that prevents him from exercising.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar university

Istanbul, Turkey (Türkiye)

Location

Related 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.

    PMID: 30774463BACKGROUND
  • 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.

    PMID: 20371557BACKGROUND
  • 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.

    PMID: 28027039BACKGROUND
  • 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.

    PMID: 24217037BACKGROUND
  • 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.

    PMID: 28630217BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Tuba KARACA

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exercise therapy and Applying a Hypervolt massager
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.Dr.

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 22, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations