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Effects of Exercise Trainings on Pain, Function and AHD in Patients With SPS

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Scapula Retraction Exercise Group
Scapula Retraction +Glenohumeral Rotational Exercise Group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring acromiohumeral distance, pain, functional level, Subacromial Impingement Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • painful arc of movement during flexion or abduction;
  • positive Neer or Kennedy-Hawkins impingement signs
  • pain on resisted lateral rotation, abduction or empty can test.

Exclusion Criteria:

  • previous shoulder surgery;
  • shoulder pain reproduced by neck movement;
  • clinical signs of full-thickness RC tears; or
  • shoulder capsulitis.

Sites / Locations

  • Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

scapula retraction exercise group

Scapula Retraction +Glenohumeral Rotational Exercise Group

Control Group

Arm Description

Manual Therapy Stretching Exercises Exercise training focus on scapulothoracic muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up.

Manual Therapy Stretching Exercises Exercise training focus on scapulothoracic muscles Exercise training focus on rotator cuff muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up.

Age-sex and hand-dominancy matched healthy controls will be included as a control group (CG) for acromiohumeral distance (AHD) normative data

Outcomes

Primary Outcome Measures

Functional Level
Functional level will be assessed by using Shoulder Pain and Disability Index (SPADİ). All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2018
Last Updated
January 20, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03494192
Brief Title
Effects of Exercise Trainings on Pain, Function and AHD in Patients With SPS
Official Title
Utilizing Scapula Retraction Exercises With or Without Glenohumeral Rotational Exercises With a Gradual Progression: A Double-Blind Randomized Controlled Trial for Subacromial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial pain syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders. The development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments. The aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.
Detailed Description
Coordinated motion between the humerus and scapula is required for pain-free arm movement. Rotator cuff and scapulothoracic muscles dynamically control the subacromial space or acromiohumeral distance (AHD).Scapulothoracic muscles need to provide stability and control in a synchronized fashion to facilitate normal scapulohumeral movement. Scapular upward rotation and posterior tilt is essential to maintain the AHD.Therefore, the force couple function of the rotator cuff muscles play an critical role in opposing the superior migration force that is generated by deltoid muscle and, to maintenance the subacromial space. Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial impingement syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders. The development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments. he aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
acromiohumeral distance, pain, functional level, Subacromial Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
scapula retraction exercise group
Arm Type
Experimental
Arm Description
Manual Therapy Stretching Exercises Exercise training focus on scapulothoracic muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up.
Arm Title
Scapula Retraction +Glenohumeral Rotational Exercise Group
Arm Type
Experimental
Arm Description
Manual Therapy Stretching Exercises Exercise training focus on scapulothoracic muscles Exercise training focus on rotator cuff muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Age-sex and hand-dominancy matched healthy controls will be included as a control group (CG) for acromiohumeral distance (AHD) normative data
Intervention Type
Other
Intervention Name(s)
Scapula Retraction Exercise Group
Other Intervention Name(s)
scapula stabilization exercises
Intervention Description
physiotherapy program consists of manual therapy, supervised stretching and scapulothoracic muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions. After 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up.
Intervention Type
Other
Intervention Name(s)
Scapula Retraction +Glenohumeral Rotational Exercise Group
Other Intervention Name(s)
Scapula stabilization +Glenohumeral Rotational Exercise Group
Intervention Description
physiotherapy program consists of manual therapy, supervised stretching and scapulothoracic and also rotator cuff muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions. After 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up
Primary Outcome Measure Information:
Title
Functional Level
Description
Functional level will be assessed by using Shoulder Pain and Disability Index (SPADİ). All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.
Time Frame
ffrom baseline to twelve week after treatment sessions
Other Pre-specified Outcome Measures:
Title
pain assessment
Description
pain intensity will de assessed by using Visual Analog Scale at rest, activity and at night. All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.
Time Frame
from baseline to 6-month follow up
Title
Acromiohumeral Distance Measurement
Description
Acromiohumeral Distance will be measured by 0°, 30°, 45°, 60° and 90° of shoulder abduction positions. All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.
Time Frame
from baseline to 6-month follow up
Title
Patient Satisfaction
Description
Patient Satisfaction will be assessed by simple questions consisting of self- recovery rate and patients expectation
Time Frame
at 12 week and 6-month follow ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: painful arc of movement during flexion or abduction; positive Neer or Kennedy-Hawkins impingement signs pain on resisted lateral rotation, abduction or empty can test. Exclusion Criteria: previous shoulder surgery; shoulder pain reproduced by neck movement; clinical signs of full-thickness RC tears; or shoulder capsulitis.
Facility Information:
Facility Name
Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will share IPD when we recruiting the patients

Learn more about this trial

Effects of Exercise Trainings on Pain, Function and AHD in Patients With SPS

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