NCT04273568

Brief Summary

The aim of this study was to investigate the effects of scapular proprioceptive neuromuscular facilitation (PNF) techniques applied in addition to exercise therapy in patients with Subacromial impingement syndrome (SIS) on pain, pressure pain threshold (PPT), range of motion (ROM), functionality, scapular dyskinesis, active trigger points and emotional state.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

February 11, 2020

Last Update Submit

February 17, 2020

Conditions

Keywords

Proprioceptive Neuromuscular FacilitationShoulder pain

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Pain intensity of the patients at 6 weeks

    Pain intensity of the patients at rest, during activity and at night was assessed using the VAS; Visual Analog Scale. In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.

    Baseline and 6 weeks

  • Change from Baseline Functional Status of the patients at 6 weeks

    The functional status of the patients were evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). DASH is a scale consisting of 30 questions that question the functional status and symptoms used in musculoskeletal disorders of the upper extremity.The number of Likert scale (1: no difficulty, 5: I can not do at all) is used in answering the questions and the total score obtained is between 0 and 100.

    Baseline and 6 weeks

Secondary Outcomes (5)

  • Shoulder Range of Motion (ROM)

    Baseline and 6 weeks

  • Pain Pressure Threshold (PPT)

    Baseline and 6 weeks

  • Scapular dyskinesis

    Baseline and 6 weeks

  • Active trigger points

    Baseline and 6 weeks

  • Emotional state

    Baseline and 6 weeks

Other Outcomes (1)

  • Patient Satisfaction: Global Rating of Change (GRC) scale

    At the end of the 6-weeks treatment

Study Arms (2)

Group1 (PNF group)

EXPERIMENTAL

Scapular PNF and exercise program was applied to the PNF group.

Other: Scapular PNFOther: Exercise program

Group 2 (Exercise group)

ACTIVE COMPARATOR

Exercise program was applied to the exercise group

Other: Exercise program

Interventions

Rhythmic initiation and repetitive stretching techniques in scapula anterior elevation-posterior depression and anterior depression-posterior elevation patterns were applied twice a week for 6 weeks.

Group1 (PNF group)

An exercise program consisting of exercises used in the conservative treatment of shoulder impingement syndrome for both groups was applied twice a week for 6 weeks.

Group 2 (Exercise group)Group1 (PNF group)

Eligibility Criteria

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

You may qualify if:

  • Aged between 20 and 60
  • Diagnosed with SIS by MRI and clinical examination and a specialist physician
  • Positive impingement tests (Hawkings, Neer and Jobe test) or painful motion arc (60 ° -120 °)
  • Unilateral shoulder pain that has been going on for at least 3 months
  • Signed voluntary consent form

You may not qualify if:

  • Diagnosed with adhesive capsulitis or massive rotator cuff tear
  • Having undergone upper limb surgery
  • Presence of rheumatological systemic diseases
  • Presence of Glenohumeral instability
  • Having a neurological disease affecting the upper extremity
  • Diagnosed with cervical radiculopathy
  • Degenerative joint disorders
  • Having communication problems
  • Steroid injection therapy or physiotherapy in the past 6 months have been rehabilitated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, 34295, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 18, 2020

Study Start

March 1, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations