NCT06531889

Brief Summary

The objective of this retrospective study was to look into the effects of core stabilization exercises applied in conjunction with classic physiotherapy program on pain, muscle strength, disability, and posture in SIS.

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 Mar 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

December 15, 2023

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • The Numerical Rating Scale (NPRS-11)

    The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.

    Change from baseline pain score at 6th week

  • New York Posture Rating Method to determine their postures

    The rating chart is used to assess 13 areas of the body, based on the assumption that posture is the alignment of the body and its segments. 13 regions (head, neck, shoulder, scapula, upper thoracic, waist, rips, abdomen, hips, knees, legs, feet and toes) are assessed in two different positions (lateral and posterior). A score is allocated to each area according to the position: 5 points to the correct position; 3 points for a slight deviation, and 1 point for a pronounced deviation. Total score is between 18-90 points. higher the points better the postural alignment

    Change from baseline pain score at 6th week

  • Shoulder pain and disability index

    The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.

    Change from baseline score of The Shoulder Pain and Disability Index at 6th week

Secondary Outcomes (4)

  • Shoulder mobility on the Shoulder Range of Motion

    Change from baseline range of motion at 6th week

  • Core muscle strength test

    Change from baseline strenght score at 6th week

  • Endurance of Core Muscles

    Change from baseline endurance score at 6th week

  • Manual muscle test

    Change from baseline manual muscle testing score at 6th week

Study Arms (2)

classical physiotherapy program

ACTIVE COMPARATOR

The group in classical physiotherapy program; n=25 (3 days per week for six weeks)

Other: classical physiotherapy program

core stabilization group

EXPERIMENTAL

The group in which core stabilization was also performed in addition to classical physiotherapy program; n=25 (3 days per week for 6 weeks)

Other: classical physiotherapy programOther: Core Stabilization Exercises

Interventions

Classical physiotherapy program=Classical physiotherapy program included transcutaneous electrical nerve stimulation, infrared radiation for 15 min, continuous ultrasound for 5 min and home exercise program. For active assistive shoulder range of motion (ROM), home exercises included the Codman exercise, flexion exercise at the ladder, and the Wand exercise, as well as some strengthening and stretching exercises performed at the pain limit with 10 repetitions twice a day (six weeks)

classical physiotherapy programcore stabilization group

The interventions of the core exercise were applied when the patient lay on his/her back with his/her knees at flexion. The number of repeats for each exercise was five, and these exercises were done 3 times a week for 6 weeks with the same physiotherapist. The further steps in the exercises were extended according to the activation duration of the core muscles, and this extension was elongated 5 s

core stabilization group

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between the ages of 35 and 60 who were diagnosed by a Physical Therapy and Rehabilitation doctor with at least ten years of experience, whose SIS was confirmed by MRI, and who had shoulder complaints for at least three months, patients with positive signs, a positive Hawkins-Kennedy test, significant loss of active and passive shoulder movements or painful range of motion (ROM), and patients whose treatment and evaluation methods were appropriate for the study design were enrolled in the study

You may not qualify if:

  • Patients who had upper extremity surgery, patients with a history of shoulder trauma and corticosteroid application to the shoulder region in the previous year, a history of shoulder dislocation, infection, tumor, adhesive capsulitis, reflex sympathetic dystrophy, congenital anomaly, rheumatic disease, and chronic severe systemic disease, as well as professional athletes and patients whose evaluations were missing in the previous month were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, +90, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Nuray ALACA

    Acibadem University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof Nuray Alaca

Study Record Dates

First Submitted

December 15, 2023

First Posted

August 1, 2024

Study Start

March 1, 2019

Primary Completion

June 1, 2019

Study Completion

August 30, 2019

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations