NCT04434183

Brief Summary

The aim of this study is to evaluate and compare the effects of home exercise program and isokinetic exercise program on pain, muscle strength, functionality, proprioception sensation and quality of life in patients with subacromial impingement syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

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

Study Start

First participant enrolled

May 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

June 9, 2020

Last Update Submit

June 16, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • Assessment of shoulder examination findings

    The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder examination findings. The investigators used to painful arc test consisting of 13 questions that scored from zero to ten.

    3 months

  • Assessment of shoulder functions

    The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder functions and muscle strenght. The investigators used to Constant-Murley functional evaluate scale consisting of four parameters that scored from zero to one hundered.

    3 months

  • Assessment of muscle strenght

    The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using newton-meter for muscle strenght and angle degree for velocity measurements.

    3 months

  • Assessment of quality of life

    The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment quality of life values with Pittsburg sleep quality index. The Pittsburg sleep quality index consisting of 23 questions that scored from zero to three.

    3 months

  • Assessment of sense of proprioseption

    The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using angle degree for sense of position.

    3 months

  • Assessment of shoulder pain

    The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder pain. The investigators used to visual analog score for pain that scored from zero to ten.

    3 months

  • Assessment of shoulder disability

    The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder disability. The investigators used to shoulder disability questionnare consisting of 16 questions that scored yes or no. Calculation; score = \[Yes counts / (Yes counts + No counts)\]x100. The score seems, zero point is maximal fine health and 100 points (maximal point) is poor health.

    3 months

  • Assessment of physical health situation

    The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for physical health situation. The investigators used to health evaluated inventory. The inventroy consisting of 20 questions that scored from zero to three per question. Zero point is maximal fine health and 60 points are maximal poor health.

    3 months

Study Arms (2)

isokinetic exercise

ACTIVE COMPARATOR

The group (isokinetic exercise group, n = 25) was given isokinetic exercise.

Device: Exercises of rehabilitation

home exercise

ACTIVE COMPARATOR

The group(home exercise group, n=25) was given home exercise program.

Device: Exercises of rehabilitation

Interventions

Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients

Also known as: Isokinetic cybex dynamometer
home exerciseisokinetic exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shoulder pain and functional disability at least 6 months

You may not qualify if:

  • Instability of shoulder, Stage 2-3 adhesive capsulitis, tendinitis or bursitis, cervical radiculopathy, underwent surgery, norological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (2)

  • Akman S, Kucukkaya M. [Subacromial impingement syndrome: pathogenesis, clinical features, and examination methods]. Acta Orthop Traumatol Turc. 2003;37 Suppl 1:27-34. Turkish.

  • Campbell RS, Dunn A. External impingement of the shoulder. Semin Musculoskelet Radiol. 2008 Jun;12(2):107-26. doi: 10.1055/s-2008-1078699.

Related Links

Study Officials

  • OMER KURU, FULL PROF

    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Administrative Director of PMR Clinic

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 16, 2020

Study Start

May 30, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations