NCT04538690

Brief Summary

20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Our hypothesis is that the balance will improve and pain will decrease in individuals after exercise.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

August 31, 2020

Last Update Submit

October 13, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Objective Balance Measurement

    By Biodex Balance System Stability and Fall Risk, static and dynamic

    4 week

  • Pain Intensity

    By Visual Analogue Scale scored between 0-10. 0 means no pain and 10 means unbearable pain.

    4 week

Secondary Outcomes (1)

  • Range of Motion

    4 week

Study Arms (2)

Control Group

NO INTERVENTION

Age and sex matched non interventional, healthy control group

Exercise Group

EXPERIMENTAL

Individuals who are taken part of shoulder exercises with painful shoulder disorders.

Other: Shoulder ExercisesOther: Electrotherapy

Interventions

Exercises consist of shoulder range of motion, releasing exercises, strength training, stretching.

Exercise Group

TENS, US

Exercise Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having one of the diagnoses of impingement, rotator cuff syndrome, frozen shoulder, biceps tendon,
  • Pain severity felt by the patient above-8 according to the Visual Analogue Scale divided into 10 equal intervals,
  • Patients who were recommended conservative treatment

You may not qualify if:

  • Any previous surgical operation,
  • Skeletal system fractures or dislocations,
  • Other diagnosed orthopedic, neurological or rheumatological diseases, diabetes, neuropathy and pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34815, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder PainMotor Activity

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gizem Ergezen, MSc

    Medipol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gizem Ergezen, MSc, Physiotherapist

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 4, 2020

Study Start

September 15, 2020

Primary Completion

November 15, 2020

Study Completion

November 20, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations