Effects of Corrective External Support and Regional Vibration Applications in Subacromial Pain Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDokuz Eylul University

About this trial

Sixty three individuals with chronic subacromial pain syndrome will be included in our study. In the evaluations to be made to the participants; Pain intensity will be measured with the Visual Analogue Scale (VAS), joint movement and shoulder proprioception will be measured with the inclinometer, and shoulder muscle strength will be measured with the digital hand dynamometer. In addition, functionality and disability levels will be determined by SPADI and Short form-Questionnaire for Arm, Shoulder and Hand Problems (Q-DASH). Supraspinatus tendon thickness and acromiohumeral space measurements will be made by ultrasonographic imaging. Patient satisfaction will be evaluated with the Visual Analog Patient Satisfaction Scale survey and quality of life will be evaluated with the SF-12 survey (The 12-item Short Form Survey).

Participants will be randomly divided into 3 groups of 21 participants each. In addition to the standard physiotherapy program, taping around the shoulder will be applied to the kinesio taping group, and localized vibration therapy around the shoulder will be applied to the localized vibration therapy group, in addition to the standard physiotherapy program. The Control Group (CG) will receive the same physiotherapy program as the other groups and will attend the same number of sessions as the other groups, accompanied by a physiotherapist. Evaluations will be made and analyzed before treatment, after 3 weeks of treatment, after 6 weeks of treatment, at 12 weeks and at the end of 24 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteering to participate in the study,

Being over 18 years of age,

Having diagnosed with subacromial impingement syndrome,

SIS-related complaints have persisted for at least 3 months,

Disqualifiers

Having a history of fractures and surgery in the upper extremity and cervicothoracic region,

Having another neurological, orthopedic or rheumatic shoulder problem such as frozen shoulder or instability,

Having a systemic musculoskeletal disease,

Known chest deformity, scoliosis diagnosis and physical disability,

Trial design

Design model

Crossover

Treatments tested in this trial

  • Standard Physiotherapy Program

    Other intervention

    Patients with Subacromial Impingement Syndrome (SIS) will receive a 6-week treatment program. Patients will be given a physiotherapy treatment program by a physiotherapist three times a week, and on the other days, patients will practice six selected simple exercises at home.

  • Kinesio Taping

    Other intervention

    In addition to the standard physiotherapy program, kinesio taping (device) will be applied.

  • Local Vibration Therapy

    Other intervention

    In addition to the standard physiotherapy program, local vibration (device) will be applied.

Treatment groups

63 Participants
are divided into 3 treatment groups
Group A: Control Group (CG) (Standard Physiotherapy Program)Active comparator 1 intervention
Group B: Kinesio Taping Group (KTG) (Standard Physiotherapy Program + Kinesio Taping)Active comparator 2 interventions
Group C: Local Vibration Therapy Group (LVTG) (Standard Physiotherapy Program + Local Vibration Therapy)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Shoulder Pain

The level of pain felt during rest and activity will be marked on a 10 cm scale and the result will be recorded by measuring with a ruler. The value '0' means no pain; '10' indicates unbearable pain.

Time frame
Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
2

Range of Motion (Active and Pain-Free)

Active shoulder abduction, flexion, internal and external rotation movements will be measured using a 1-degree interval water-controlled inclinometer (Fabrication End Inc, NewYork, USA) while the patient is in the supine position. Pain-free joint range is the angle at which the patient first feels pain during active movement. Pain-free joint motion will be assessed by measuring pain-free joint motion during active shoulder elevation in the scapular plane with an inclinometer. While the patient is sitting in a chair with back support and lifts his arm up with his thumb pointing up, the angle at which he first feels pain will be recorded one degree below.

Time frame
Baseline, and after 6 weeks of interventions period
3

Muscle Strength

Change of trapezius,serratus anterior, supraspinatus and shoulder internal rotation isometric strength (in kg, with hand held dynamometer).The average of three consecutive repetitions will be recorded.

Time frame
Baseline, and after 6 weeks of interventions period
4

Shoulder Pain and Disability Index (SPADI)

Shoulder Pain and Disability Index has 3 subscales: total, pain and disability. The pain subscale consists of 5 questions about shoulder pain during daily living activities, and the disability subscale consists of 8 questions about difficulty in performing daily living activities. A high score indicates increased pain and impaired shoulder function.To answer the questions, patients place a mark on a 10cm visual analogue scale for each question.The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

Time frame
Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

Secondary outcomes

1

Patient Satisfaction Rating

The patient's symptom status (degree of improvement), physiotherapist (care provided) and overall satisfaction with the treatment will be evaluated by giving a score out of 10 with the Visual Analog Patient Satisfaction Scale. The lowest level individual is not satisfied at all; The highest level indicates that they are completely satisfied. In follow-up evaluations, only symptoms (degree of improvement) will be questioned.

Time frame
Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
2

Assessment of the Patient's Perceived Change in Condition

The patient's perceived change in condition will be measured using the Global Change Rating Scale. This rating scale measures the person's perception of the change in their condition after treatment. The patient evaluates the overall change from the day he started treatment to the day he finished treatment using a 7-point Likert Scale. On the scale, a score of -7 would be scored as much, much worse, a score of 0 would be scored as almost the same, and a score of +7 would be scored as much, much better.

Time frame
Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
3

Ultrasonographic Measurements

Ultrasonographic measurements will be performed by examining images obtained in 2D using the LOGIQ e ultrasonography unit (LOGIQ e Ultrasound, GE(General Electric Company ) Healthcare, USA). A 7-12 megahertz(MHz) linear transducer will be used in the evaluations. To measure supraspinatus tendon thickness, the transducer will be placed perpendicular to the supraspinatus tendon in the anterior of the shoulder and two measurements will be made and the average will be taken. For acromiohumeral distance measurement, images of the humerus and acromion will be taken together at 0◦ and 60◦ scapular plane shoulder elevation, with the location of the transducer as the standard, 2.1 cm behind the first acromial arch in the coronal plane. It gives the shortest distance determined by 2D linear measurement between the acromion and humerus on the recorded images. The average of the measurements taken from the 1st and 2nd measurement locations will be recorded.

Time frame
Baseline, and after 6 weeks of interventions period
4

Proprioception

Change of shoulder abduction joint position sense (with digital inclinometer in degree) (Target angel:100 degree abduction). The target angle to be tested will be taught by the investigators with eyes open 3 times and eyes closed 3 times. The participant will then be asked to bring it to the target angle with their eyes closed. The deviation value from the target angle will be recorded.

Time frame
Baseline, and after 6 weeks of interventions period

Other outcomes

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