NCT06374004

Brief Summary

The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.

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 Apr 2024

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

April 10, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

April 11, 2024

Last Update Submit

July 25, 2024

Conditions

Keywords

RehabilitationElectromyographyAcromiohumeral DistancePain

Outcome Measures

Primary Outcomes (2)

  • Electromyography (EMG)

    A surface EMG system with 8 channels will use to measure muscle activation levels. A synchronized video record will take at 50 frames per second to identify 3 phases of the exercises ascending phase of the abduction (from 0°-60°, 60°-120°, and 120°-180°). Measurements will make from the affected side. The same examiner will place bipolar Ag-Cl surface electrodes over the Upper Trapezius (UT), Middle Trapezius (MT), Lower Trapezius (LT), Infraspinatus (IS), Middle Deltoid (MD), and Serratus Anterior (SA) muscles of all participants. Investigators will measure maximal voluntary isometric contractions (MVICs) of the UT, MT, LT, IS, MD, and SA muscles in randomized order first. The width of the wooden blocks will adjust according to the arm distance of the patients. Shoulder abduction angles of 60° and 120° will mark with tape on the wooden blocks.

    twelve weeks

  • Acromiohumeral Distance (AHD)

    Real-time ultrasonography (US) images of the subacromial space will obtain with a 4 to 13 Megahertz linear transducer. All US images will evaluate by the same researcher with 5 years of experience in US imaging of the shoulder. US images will obtain from the affected side shoulder. The AHD will measure linearly (as a millimetres) between the highest point of the humeral head and the lowest point of the acromion using the on-screen calibrations of the US system. Measurements will do at 0°, 60° and 90° abduction of the shoulder.

    twelve weeks

Secondary Outcomes (3)

  • Muscle Tone

    twelve weeks

  • Functional Activity Level

    twelve weeks

  • Pain Intensity

    twelve weeks

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

The exercise group will perform stretching and strengthening exercises involving the muscle groups around the shoulder and scapula for 12 weeks.

Other: Exercise Group

Thoracic Mobilization Group

ACTIVE COMPARATOR

The exercise group will perform stretching and strengthening exercises involving the muscle groups around the shoulder and scapula for 12 weeks. In addition to the exercises, thoracic mobilization will be applied to the participants in this group 1 day a week for a total of 6 weeks.

Other: Exercise GroupOther: Thoracic Mobilization Group

Interventions

The exercises will be given as a home program and each exercise will be performed 2 times a day for a total of 12 weeks. Participants will perform the exercises 1 day a week under the supervision of a physiotherapist. The exercise program lasts approximately 30 minutes.

Exercise GroupThoracic Mobilization Group

The exercises will be given as a home program and each exercise will be performed 2 times a day for a total of 12 weeks. Participants will perform the exercises 1 day a week under the supervision of a physiotherapist. The exercise program lasts approximately 30 minutes. Thoracic mobilization will be applied to segments where passive accessory movement is insufficient or painful. 30 repetitions/4 sets will be applied to each determined segment. Thoracic mobilization will be performed with the patient lying prone position.

Thoracic Mobilization Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Thoracic kyphosis angle \> 40°
  • Full active shoulder abduction

You may not qualify if:

  • Bilateral shoulder pain
  • Rotator cuff tear
  • Shoulder/cervical injury other than SAPS
  • Surgery history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • MAHMUT ÇALIK, PhD Student

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomly divided into two groups and participants will not know which group participants are in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group received exercise therapy and the other group received manual therapy (thoracic mobilization) in addition to exercise therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD Student, Principal Investigator

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 18, 2024

Study Start

April 10, 2024

Primary Completion

July 5, 2024

Study Completion

July 5, 2024

Last Updated

July 26, 2024

Record last verified: 2024-07

Locations