NCT04392934

Brief Summary

In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (SIS) and its relation to the acromion morphology.

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 Jan 2020

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

January 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 11, 2020

Last Update Submit

May 13, 2020

Conditions

Keywords

physiotherapyacromion morphologysubacromial impingement syndrome

Outcome Measures

Primary Outcomes (6)

  • Visual Analog Scale (VAS)

    Pain at rest and pain at activity was measured by Visual Analog Scale (VAS). High score was determined as high level of pain. Visual analog scale (VAS) was ranging from 0 cm (no pain) to 10 cm (worst imaginable pain).

    4 weeks

  • Muscle strength

    Muscle strength tests for shoulder flexion, extension, abduction, adduction, internal and external rotation were done by a dynamometer (NK-500, AIPU, Anhui, China).

    4 weeks

  • Range of motion

    Goniometric measurements were applied by a universal goniometer to determine the range of motion in terms of flexion, extension, abduction, adduction, internal and external rotation directions.

    4 weeks

  • Joint position sense

    The joint position sense was evaluated by a laser pointer. During the test, 90˚ shoulder flexion and 90˚ shoulder abduction movements were evaluated. A laser pointer was fixed with a velcro 5 cm above the elbow. The patient was asked to bring the shoulder to 90˚ flexion while the patient's eyes were open and meanwhile, the measurement was made by the physiotherapist with a goniometer. The patient was asked to fix this position for 10 seconds. The projection of the laser pointer on millimeter paper was marked. The patient repeated this movement 3 times with eyes open and memorized it. The patient returned to the neutral position and closed her eyes then repeated the flexion movement 3 times and the projection of the laser pointer on millimeter paper was marked. The same procedure was performed for shoulder abduction. The deviation between the measurements was calculated.

    4 weeks

  • Painful arc sign

    The patient was asked to perform active shoulder abduction, and the difference between the angle at which the pain first occurred and the angle at which the pain ended was noted during this movement pattern. Measurements were made on the affected shoulder joint by a goniometer

    4 weeks

  • Functionality

    To assess the functional levels of the patients, the Shoulder Pain and Disability Index (SPADI) was used.

    4 weeks

Study Arms (3)

flat shape acromion group

EXPERIMENTAL

a conservative physiotherapy protocol was applied for 4 weeks

Procedure: a conservative physiotherapy protocol

curved shape acromion group

EXPERIMENTAL

a conservative physiotherapy protocol was applied for 4 weeks

Procedure: a conservative physiotherapy protocol

hooked shape acromion group

EXPERIMENTAL

a conservative physiotherapy protocol was applied for 4 weeks

Procedure: a conservative physiotherapy protocol

Interventions

5 minutes of ultrasound (Business Line US 50, Medical Italia, Italy) at a frequency of 1 MHz and intensity of 1.5 watts/cm², 20 minutes of conventional TENS (BTL-5000, UK ) applied to the patients. Then Codman's exercises, shoulder wheel activity, isometric exercises, range of motion exercises, capsular stretching, scapular stabilization exercises, and muscle strengthening exercises were done by patients. After the treatment, cold pack was applied to the shoulder for 10 minutes. The modalities in the treatment program were applied for a total of 20 sessions 5 days per week.

curved shape acromion groupflat shape acromion grouphooked shape acromion group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who were diagnosed (clinically and by MRI) with SIS by the physician, at a stage of II-III levels according to Neer's criteria, who were undergoing physiotherapy for the first time and who had not received any treatment from the shoulder region before were included in this study.

You may not qualify if:

  • Patients who had a history of fracture in the upper extremity and, surgical operation from any part of the upper extremity, who had acute cervical disc herniation or a neuromuscular disease, receiving a medical therapy for pain relief, less than 80 % participation to sessions were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Begumhan Turhan

    Hasan Kalyoncu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Participants are grouped according to their acromion type. First group is flat shape acromion group, second is hook shape group and the third one is curved shape acromion group. All groups are treated with the same physiotherapy protocol.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 19, 2020

Study Start

January 10, 2020

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations