Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06374004
Other study ID # HU-FTR-MC-01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 10, 2024
Est. completion date July 5, 2024

Study information

Verified date April 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Subacromial pain syndrome (SAPS) is the most common shoulder problem and accounts for 44%-65% of all shoulder problems. Repetitive compression of the rotator cuff tendons as they pass through the subacromial space affects shoulder function along with pain. Studies have shown that scapular kinematics are affected in individuals with subacromial pain syndrome. In addition to increased scapular internal rotation, scapular upward rotation and posterior tilt during elevation are decreased in these individuals. These kinematic changes have been associated with decreased activation of the middle and lower trapezius and serratus anterior muscles and excessive upper trapezius activation. This change in scapular kinematics causes narrowing of the subacromial space and repeated traumatization of the rotator cuff muscles passing through it. In addition, kyphotic posture in the thoracic region (insufficient extension of the thoracic vertebrae) negatively affects scapular kinematics. Kyphotic posture has been shown to be associated with subacromial pain syndrome by causing anterior tilt, downward rotation and protraction in the scapula. Exercise and mobilization applications are frequently applied in subacromial pain syndrome. Strengthening the muscles around the shoulder and scapula, increasing glenohumeral and scapulothoracic joint mobility, and stretching the posterior capsule are frequently applied to reduce pain and increase function. Studies on increasing thoracic mobilization are limited in number. In these studies, the acute effects of thoracic manipulation applications on pain, normal joint motion and functional activity level were examined in individuals with subacromial pain syndrome. There is only one pilot study that examined the effect of mobilization applied to the thoracic region. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 32
Est. completion date July 5, 2024
Est. primary completion date July 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Thoracic kyphosis angle > 40° - Full active shoulder abduction Exclusion Criteria: - Bilateral shoulder pain - Rotator cuff tear - Shoulder/cervical injury other than SAPS - Surgery history

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise 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 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.

Locations

Country Name City State
Turkey Hacettepe University, Faculty of Physical Therapy and Rehabilitation Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Muscle Tone The participant's upper trapezius muscle tone will assess. Measurements will make by placing the tip of the muscle tone assessment device vertically at the midpoint of the individuals' upper trapezius muscle. The resulting changes in muscle tone and stiffness will record as results. twelve weeks
Secondary Functional Activity Level American Shoulder and Elbow Surgeons (ASES) will use to determine functional activity level. ASES is frequently use in the evaluation of shoulder functions in rotator cuff injuries. Participants can score between 0-100 points in the ASES assessment. A high score on the ASES assessment indicates high activity level and low disability level.The Turkish version of the questionnaire will use in our study. twelve weeks
Secondary Pain Intensity A pain intensity will evaluate with the Visual Analog Scale (VAS). Participants will ask to mark the intensity of pain participants feel during rest and night pain and daily life activity on a 0-10 cm straight line. The length between the point will mark by the patient and the starting point on the line will measure with a ruler and the pain intensity will record in cm. twelve weeks
See also
  Status Clinical Trial Phase
Completed NCT06139120 - The Segmental Distribution of Hypersensitivity in Patients With Chronic Subacromial Pain Syndrome
Completed NCT05549674 - Copenhagen Cohort of Patients With Shoulder Pain
Completed NCT05402514 - Digitally Delivered Exercise and Education Treatment for Shoulder Pain: 3 Months Follow-up
Completed NCT03317808 - Exercise for Subacromial Pain Syndrome N/A
Recruiting NCT05951933 - Transcranial Electrical Stimulation in Subacromial Pain Syndrome N/A
Completed NCT04952623 - Online Education to Improve the Management of Rotator Cuff Related Shoulder Pain N/A
Completed NCT05200130 - Effectiveness of Telerehabilitation on Subacromial Pain Syndrome N/A
Not yet recruiting NCT06409442 - Effects of Corrective External Support and Regional Vibration Applications in Subacromial Pain Syndrome N/A
Recruiting NCT06229925 - Effects of Transcranial Direct Current Stimulation Versus Sham in Subacromial Pain Syndrome N/A
Completed NCT05205369 - Effects of Yi Jin Bang Exercise and Usual Exercise Therapy in Adults With Subacromial Pain Syndrome N/A
Withdrawn NCT04834271 - Effects of Blood Flow Restriction Training in Rotator Cuff Related Shoulder Pain N/A
Recruiting NCT04923477 - Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms N/A
Completed NCT03168477 - Dry Needling and Manipulation vs. Mobilization, Exercise and Interferential Electrotherapy for Shoulder Impingement (Subacromial Pain Syndrome) N/A
Recruiting NCT04813757 - Scapular Upward Rotation Focused Treatment for Patient With Shoulder Impingement Syndrome and a Positive Scapular Assistance Test N/A
Completed NCT05408949 - Comparison of SEP Exercises Versus SSMP With Tendon Loading & Resistance Exercise in Shoulder Pain. N/A
Not yet recruiting NCT06276192 - Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care N/A
Withdrawn NCT04738461 - The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome N/A
Completed NCT05524870 - The Effect of Manual Therapy on Central Sensitization N/A
Completed NCT03338283 - Electro-massage in Subjects With Subacromial Pain Syndrome N/A
Completed NCT04599127 - The Effect of Mobilization With Movement in Individuals With Shoulder Impingement Syndrome N/A