Trial Outcomes & Findings for Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome (NCT NCT02153827)

Results Overview

shoulder functional self report measure is a disease specific self reported outcome measure for individuals experiencing rotator cuff pathology. A score of 0 is the minimum score and indicates low levels of shoulder function. A score of 100 is the maximum score and indicates full shoulder function. Scores are derived by summing all 5 subscales and dividing that number by the total available number of 2100. Units for each item are derived from a visual analog scale totaling 100cm.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

6 months

Results posted on

2016-10-20

Participant Flow

March 2014 - October 2015 participants were recruited from the local community via publicly displayed flyers.

none to report

Participant milestones

Participant milestones
Measure	Eccentric External Rotator Training Eccentric Shoulder External Rotator Training	General Shoulder Exercise General Shoulder exercise: general exercise consisting of active shoulder movements
Overall Study STARTED	25	23
Overall Study COMPLETED	22	14
Overall Study NOT COMPLETED	3	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Eccentric External Rotator Training Eccentric Shoulder External Rotator Training	General Shoulder Exercise General Shoulder exercise: general exercise consisting of active shoulder movements
Overall Study Lost to Follow-up	3	9

Baseline Characteristics

Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eccentric External Rotator Training n=25 Participants Eccentric Shoulder External Rotator Training Eccentric Shoulder External Rotator Training	General Shoulder Exercise n=23 Participants General Shoulder exercise: general exercise consisting of active shoulder movements	Total n=48 Participants Total of all reporting groups
Age, Continuous	43.35 years STANDARD_DEVIATION 17.88 • n=5 Participants	48.35 years STANDARD_DEVIATION 16.89 • n=7 Participants	45.85 years STANDARD_DEVIATION 17.38 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Body mass	79.87 Kilograms STANDARD_DEVIATION 15.04 • n=5 Participants	81.90 Kilograms STANDARD_DEVIATION 18.55 • n=7 Participants	80.88 Kilograms STANDARD_DEVIATION 16.795 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

shoulder functional self report measure is a disease specific self reported outcome measure for individuals experiencing rotator cuff pathology. A score of 0 is the minimum score and indicates low levels of shoulder function. A score of 100 is the maximum score and indicates full shoulder function. Scores are derived by summing all 5 subscales and dividing that number by the total available number of 2100. Units for each item are derived from a visual analog scale totaling 100cm.

Outcome measures

Outcome measures
Measure	Eccentric External Rotator Training n=22 Participants Eccentric Shoulder External Rotator Training	General Shoulder Exercise n=14 Participants General Shoulder exercise: general exercise consisting of active shoulder movements
Change in Western Ontario Rotator Cuff Index	92.72 units on a scale derived from 100cm vas Standard Deviation 8.98	77.15 units on a scale derived from 100cm vas Standard Deviation 15.91

SECONDARY outcome

Timeframe: 6 months

Global rating of change is a single item questionnaire asking about total change since beginning treatment. The scale ranges from -7 (a great deal worse) to +7 (a great deal better). The unit of measure is scores on a scale.

Outcome measures

Outcome measures
Measure	Eccentric External Rotator Training n=22 Participants Eccentric Shoulder External Rotator Training	General Shoulder Exercise n=14 Participants General Shoulder exercise: general exercise consisting of active shoulder movements
Global Rating of Change	5.00 units on a scale Standard Deviation 2.25	2.50 units on a scale Standard Deviation 2.65

SECONDARY outcome

Timeframe: 6 months

0-10 pain scale with 0 meaning no pain and 10 being maximal pain. This is derived from a single item questionnaire.

Outcome measures

Outcome measures
Measure	Eccentric External Rotator Training n=22 Participants Eccentric Shoulder External Rotator Training	General Shoulder Exercise n=14 Participants General Shoulder exercise: general exercise consisting of active shoulder movements
Numeric Pain Rating Scale	1.04 units on a scale 0-10 Standard Deviation 1.62	2.14 units on a scale 0-10 Standard Deviation 1.83

SECONDARY outcome

Timeframe: 6 months

Degrees of shoulder elevation with 0 being the least and 180 being the greatest.

Outcome measures

Outcome measures
Measure	Eccentric External Rotator Training n=22 Participants Eccentric Shoulder External Rotator Training	General Shoulder Exercise n=14 Participants General Shoulder exercise: general exercise consisting of active shoulder movements
Shoulder Active Range of Motion	175 Degrees Standard Deviation 11	170 Degrees Standard Deviation 15

SECONDARY outcome

Timeframe: 6 months

Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.

Outcome measures

Outcome measures
Measure	Eccentric External Rotator Training n=22 Participants Eccentric Shoulder External Rotator Training	General Shoulder Exercise n=14 Participants General Shoulder exercise: general exercise consisting of active shoulder movements
Upper Quarter Y Balance Test	1.21 cm of reach divided by limb length Standard Deviation 13	1.12 cm of reach divided by limb length Standard Deviation .29

Adverse Events

Eccentric External Rotator Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Shoulder Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Chaconas

University of St. Augustine

Phone: 904-826-0084

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place