Trial for Shoulder Pathology and Pain in Chronic SCI

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03521856

Enrollment

Registered

2018-05-11

Start date

2012-05-02

Completion date

2016-08-31

Last updated

2022-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

spinal cord injuries, SCI

Brief summary

This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.

Interventions

BEHAVIORALshoulder exercise

Exercises performed 3 times a week for 12 weeks

BEHAVIORALeducation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Candidates will be men or women, 18 years of age or older. 2. Candidates must have an SCI and be at least 1 year post-diagnosis 3. Candidates must use a wheelchair (manual or electric) for at least the majority of the time. 4. Candidates must be able to transfer themselves without the help of others. 5. The presence of at least moderate shoulder pain (rating of \>= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months.

Exclusion criteria

1. Patients younger than 18 years of age. 2. Patients who have a history of pre-injury rotator cuff tears or shoulder injury. 3. Patients who do not use a wheelchair (manual or electric) at least 50% of the time.

Design outcomes

Primary

Measure	Time frame	Description
Change in shoulder pathology	Baseline to week 12	Quantitative ultrasound measures of the supraspinatus tendon

Secondary

Measure	Time frame	Description
Change in shoulder pain using the numerical rating scale	Baseline to week 12	Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)
Change in shoulder pain using the WUSPI	Baseline to week 12	Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)
Change in shoulder pathology	Baseline to week 16	Quantitative ultrasound measures of the supraspinatus tendon

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026