NCT06156475

Brief Summary

The aim of this study is to investigate the effectiveness of Electromyographic Biofeedback with proprioception exercises on pain, range of motion, muscle strength, proprioception and functionality 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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

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

May 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
Last Updated

December 11, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 27, 2023

Last Update Submit

December 5, 2023

Conditions

Keywords

Shoulder impingement syndromeshoulder painproprioceptionbiofeedback

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand scale

    The Disabilities of the Arm, Shoulder and Hand scale was used to measure shoulder function. The Disabilities of the Arm, Shoulder and Hand scale consists of 30 items. The total score that can be obtained from items scored between 1-5 varies between 0-100. An increase in the score indicates a decrease in function.

    8 weeks

Secondary Outcomes (5)

  • Visual analogue scale

    8 weeks

  • Joint range of motion

    8 weeks

  • Muscle strength

    8 weeks

  • Proprioception

    8 weeks

  • Patient satisfaction

    8 weeks

Study Arms (2)

Proprioception Exercise Group

EXPERIMENTAL

Wand exercises and Proprioception exercises

Procedure: Proprioception exercisesProcedure: Wand Exercise

Proprioception exercises with Electromyographic Biofeedback

ACTIVE COMPARATOR

Wand exercises and Proprioception exercises with Electromyographic Biofeedback

Procedure: Proprioception exercises with Electromyographic BiofeedbackProcedure: Wand Exercise

Interventions

Patients trained for proprioception exercises.

Proprioception Exercise Group

Patients trained for Proprioception exercises with Electromyographic Biofeedback

Proprioception exercises with Electromyographic Biofeedback
Wand ExercisePROCEDURE

Patients were educated with wand exercises.

Proprioception Exercise GroupProprioception exercises with Electromyographic Biofeedback

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with subacromial impingement syndrome,
  • Being between the ages of 18 and 65,
  • Not having received medical treatment,
  • Not having received a shoulder-related physiotherapy program in the last year,
  • Not having had any shoulder-related surgery,

You may not qualify if:

  • Neurological deficits of the upper extremity and the presence of another orthopedic disorder, rheumatic or congenital disease other than subacromial impingement syndrome,
  • Presence of mental problem,
  • Having received corticosteroid treatment in the last year,
  • Upper extremity fracture,
  • Acute cervical pathology,
  • Having cardiovascular and systemic diseases that prevent working,
  • Pregnancy,
  • Those with communication problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, Florya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ebru Kaya Mutlu, Professor

    Bandırma Onyedi Eylül University

    PRINCIPAL INVESTIGATOR
  • Buse Aydin, M.Sc.

    Istabul Aydin University

    STUDY CHAIR
  • Yasemin Karaaslan, Asst. Prof.

    Mustafa Kemal University

    STUDY CHAIR
  • Hanifegül Taskiran, Professor

    Istanbul Aydın University

    STUDY CHAIR
  • Nezih Ziroglu, MD

    Acıbadem Mehmet Ali Aydınlar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study consisted of patients with subacromial impingement syndrome evaluated by an orthopedist. Patients who met the inclusion criteria were divided into two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 5, 2023

Study Start

May 1, 2021

Primary Completion

August 1, 2021

Study Completion

December 1, 2021

Last Updated

December 11, 2023

Record last verified: 2023-11

Locations