Comparison of the Effects of Home Exercise and Isokinetic Exercise Program in Subacromial Impingement Syndrome Patients

Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)
Overall Status
Completed
CT.gov ID
NCT04434183
Collaborator
(none)
50
1
2
6
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Exercises of rehabilitation
N/A

Detailed Description

The study was designed prospectively. A total of 50 patients with subacromial impingement syndrome according to clinical and MRI findings with shoulder pain for at least 3 months were included in the study. Patients were randomly divided into two groups. The first group (isokinetic exercise group, n = 25) was given isokinetic exercise. The second group(home exercise group, n=25) was given home exercise program. Patients were evaluated before and after treatment and 3 months after the end of treatment. In the evaluation, VAS, Shoulder Pain and Disability Index, Constant Murley Scoring, Shoulder Disability Questionnaire, Health Assessment Questionnaire, Pittsburgh Sleep Quality Index, Humic Norm II isokinetic device were used. At statistically evaluation of data Student T Test and Mann Whitney U tests were used. In qualitative datas comparison Ki-Kare Test was used. Significance was evaluated at the level of p< 0.05.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effects of Home Exercise Program and Isokinetic Exercise Program on Pain, Muscle Strength, Functionality, Sense of Proprioception and Quality of Life in Subacromial Impingement Syndrome Patients
Actual Study Start Date :
May 30, 2018
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Nov 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: isokinetic exercise

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

Device: Exercises of rehabilitation
Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients
Other Names:
  • Isokinetic cybex dynamometer
  • Active Comparator: home exercise

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

    Device: Exercises of rehabilitation
    Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients
    Other Names:
  • Isokinetic cybex dynamometer
  • Outcome Measures

    Primary Outcome Measures

    1. Assessment of shoulder examination findings [3 months]

      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.

    2. Assessment of shoulder functions [3 months]

      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. Assessment of muscle strenght [3 months]

      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.

    4. Assessment of quality of life [3 months]

      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.

    5. Assessment of sense of proprioseption [3 months]

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

    6. Assessment of shoulder pain [3 months]

      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.

    7. Assessment of shoulder disability [3 months]

      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.

    8. Assessment of physical health situation [3 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Shoulder pain and functional disability at least 6 months
    Exclusion Criteria:
    • Instability of shoulder, Stage 2-3 adhesive capsulitis, tendinitis or bursitis, cervical radiculopathy, underwent surgery, norological diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prof Dr Cemil Tascioglu City Hospital Istanbul Turkey 34384

    Sponsors and Collaborators

    • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    Investigators

    • Study Chair: OMER KURU, FULL PROF, Prof. Dr. Cemil Tascıoglu City Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sevgi Atar, Administrative Director of PMR Clinic, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
    ClinicalTrials.gov Identifier:
    NCT04434183
    Other Study ID Numbers:
    • 851
    First Posted:
    Jun 16, 2020
    Last Update Posted:
    Jun 18, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 18, 2020