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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02670174
Other study ID # 2015/0816
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date June 2018

Study information

Verified date December 2023
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized controlled trial will be conducted to examine the effectiveness of a traditional home exercise program versus 2 kinetic chain home exercise programs on treatment outcome of overhead athletes with shoulder impingement syndrome. Primary outcome measures are reduction of pain and disability, and improvement in functionality and sports performance. Secondary outcome measures are strength, mobility, flexibility and functional performance.


Description:

Participant are randomly assigned in 3 home exercise groups. 1. The traditional program: consists of solely strengthening the rotator cuff muscles and scapular muscles (e.g. external rotation) 2. Separate kinetic chain program: same exercises as the first group but they also receive an exercise program to separately train the core and lower body. (e.g. external rotation separately and squat separately) 3. Integrated kinetic chain program: same exercises as the first group but all exercises are performed while simultaneously activating the kinetic chain. (e.g. external rotation while squatting).


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Symptoms of shoulder impingement on the dominant side for at least 3 months and at least 3 of the following tests are considered positive - Jobe - Hawkins - Neer - Painful arc during elevation - Pain or lack of force production with isometric external rotation - Apprehension test - Relocation test - Performing overhead sports at least 3 hours/week - Shoulder pain interferes with sports activities - They have not had treatment for this shoulder pain Exclusion Criteria: - History of shoulder dislocation or subluxation - History of orthopedic surgery - No complaints of pain or dysfunction in the upper limb (except impingement related complaints in the dominant shoulder), lower limb or spine at the last 6 months - Currently taking nonsteroidal anti-inflammatory medication - Received a steroid injection in the past 12 months - Participating in another study - Known systemic diseases - Known structural diseases

Study Design


Intervention

Other:
Traditional training

Separate kinetic chain training

Integrated kinetic chain training


Locations

Country Name City State
Belgium Vakgroep REVAKI (Ghent University - Ghent University hospital) Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Shoulder Pain And Disability Index (SPADI) score Patients will fill in the SPADI questionnaire to evaluate shoulder pain and function. The SPADI is a valid, reliable and frequently used questionnaire for shoulder pain patients consisting of 13 items divided in 2 subscales: pain (5 items) and disability (8 items). Each item was scored on a 10-point numeric rating scale. Total and subscale scores were summed and transformed to a score out of 100 (%) were a higher score indicates a higher level of pain and/or disability At baseline and within one week after the 6-weeks training program
Primary Changes in Western Ontario Shoulder Stability index (WOSI) score The WOSI is a patient-evaluated disease-specific quality of life scoring questionnaire that has been developed for shoulder instability patients. This 21-item questionnaire consists of 4 subscales: physical symptoms (10 items), sport/recreation/work (4 items), lifestyle (4 items), and emotions (3 items). Each item was scored on a 100-mm visual analogue scale. Total and subscale scores were summed and transformed to a score out of 100 (%) where a higher score indicates more limitations in shoulder related quality of life At baseline and within one week after the 6-weeks training program
Primary Subjective perception of shoulder improvement A Global Rating of Change (GROC) scale was used to quantify patient-perceived improvement of overall shoulder function after 6 weeks treatment as "improved", "unchanged" or "worse". In case they improved or got worse, the amount of change was reflected on a 5-point scale: very little change, little change, some change, a large change, a very large change. An "unchanged" condition scored 0, "improved" between 1 and 5, and "worse" between -1 and -5 points.
amount of change was scored on a 5-point scale (very little change, little change, some change, a large change, a very large change)
6-weeks training program
Secondary Changes in shoulder muscle isokinetic strength (Biodex system 4) Isokinetic strength of shoulder internal and external rotators will be measured bilateral with the Biodex device (Biodex system 4, Biodex Medical Systems, Inc., Shirley, New York, USA). For further analysis, concentric peak torque (PT) (rotation) or peak force (PF) (protraction-retraction) values were normalized to body weight (BW). A higher value represents more strength and thus a better outcome. at baseline and within one week after the 6-weeks training program
Secondary Changes in shoulder scapular isokinetic strength Isokinetic strength of scapular protraction and retraction muscles will be measured bilateral with the Biodex device (Biodex system 4, Biodex Medical Systems, Inc., Shirley, New York, USA). For further analysis, concentric peak torque (PT) (rotation) or peak force (PF) (protraction-retraction) values were normalized to body weight (BW). A higher value represents more strength and thus a better outcome. at baseline and within one week after the 6-weeks training program
Secondary Changes in scapular dyskinesis Scapular dyskinesis will be measured by observing the scapular movement during active elevation. For both sides (left and right), scapular dyskinesis was evaluated as being present or not. In case dyskinesis was present, the amount of dyskinesis is scored as subtle or prominent. at baseline and within one week after the 6-weeks training program
Secondary Changes in functional tests for the upper limb measured with the Y Balance Test The YBT-UQ is a commonly used upper extremity functional test to assess closed kinetic chain function of the stance arm while performing an open kinetic chain movement in the reaching arm. Under standardized verbal encouragement, patients stand in a three point plank position while using the free arm to push a reach indicator box as far as possible in 3 reach directions i.e. medial, inferolateral and superolateral.The average of the 3 test trials for each limb and each direction was normalized for upper limb length. Additionally, a normalized composite score per side was calculated by averaging the mean normalized test scores in the 3 reach directions. A higher scores indicates a better outcome. at baseline and within one week after the 6-weeks training program
Secondary Return To Play (RTP) Is it possible to return to play after 6 weeks intervention or not? In addition, following question was asked: on a scale of 0 to 100%, what is the extent to which the injured shoulder has reached the shoulder function before the injury occurred? up to one week after the 6-weeks training program
Secondary Changes in functional tests for the upper limb measured with the Seated Medicine Ball Throw The SMBT is an open kinetic chain functional screening test to assess bilateral upper body power and strength. The subjects were instructed to sit on the floor with the head, shoulder and back against the wall while holding a 2kg medicine ball with both arms.Participants had to throw the medicine ball forward, in a straight line and as far as possible with head, shoulders and back maintaining full wall contact. For further analysis, the mean distance of 4 test trials was calculated. A higher scores indicates a better outcome. at baseline and within one week after the 6-weeks training program
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