Maintenance of Shoulder Health and Function After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Southern California Spinal Cord Injury Model System: A Randomized Clinical Trial to Evaluate Two Prevention Programs for Maintenance of Shoulder Health and Function After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135978
• Other study ID #: H133N110018
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: April 9, 2018
• Start date: April 2012
• Est. completion date: July 2017

Study information

• Verified date: April 2018
• Source: Rancho Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a shoulder exercise program can prevent the onset of shoulder pain and improve community participation in persons who have a spinal cord injury (SCI). Upon entry into the study patients will have pain-free shoulders and will be followed for 3 years to determine rate of shoulder pain development. Patients will learn a simple shoulder home exercise program and will be instructed on techniques to protect their shoulder during wheelchair propulsion, transfers and activities of daily living. Patients will be instructed to perform the home exercise program 3 days per week. Two types of treatment (training) delivery approaches that have been documented to reduce chronic shoulder pain will be compared. The rate of shoulder pain development for the two groups will be compared to the rate of shoulder pain development in the historical control group. The investigators hypothesize that the rate of shoulder pain development will be lower in the experimental treatment groups compared to the historical control group. Any differences between the two treatment delivery approaches for the experimental treatment groups will help to provide guidelines for the most effective delivery approach of a shoulder pain prevention program.

Description:

All persons are at risk for shoulder pain from a shoulder injury or rotator cuff injury. Persons with SCI are at a greater risk because of the increased use of their shoulders. Lifestyle changes following SCI place a large demand on an individual's shoulders. Pushing a wheelchair, transferring, and performing pressure relief raises are three common activities that put added strain on the shoulders. In addition to these activities, reaching from a wheelchair can put strain on the shoulder because many environments are not ideally set up for wheelchair users. These new stressors are believed by the medical community to lead to shoulder pain. The prevalence of shoulder pain for persons with spinal cord injury is 30-70%. Untreated, shoulder pain may lead to additional losses in function and community mobility.

Previous research shows that shoulder exercises along with education on how to improve one's technique for wheelchair propulsion, transfers, and weight relief raises can significantly reduce chronic shoulder pain and improve quality of life. The investigators aim to not only reduce existing shoulder pain, but also to prevent the onset of new pain.

The current study will teach the same 4 simple shoulder strengthening exercises performed in the prior study to patients with healthy shoulders. Half of the patients will receive 2 sessions of one-to-one training with a physical therapist, and the other half will receive 4 sessions of training combined with an interactive education program on techniques to protect their shoulder in a class format led by a physical therapist and a peer mentor with a spinal cord injury. Patients will be followed for 3 years to learn if they develop shoulder pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• spinal cord injury

• at least 2 years duration post spinal cord injury and no greater than 20 years duration post spinal cord injury

• at least 18 years of age

• free of shoulder pain that interferes with daily activities or requires medical intervention at the time of enrollment in the study

• a total score on the "Wheelchair User's Shoulder Pain Index" of 10 or less

• adequate arm strength and movement to perform the shoulder exercise program

Exclusion Criteria:

• positive shoulder impingement signs (positive Hawkins-Kennedy test and painful arc in shoulder abduction or flexion)

• biceps tendonitis (positive Speed's test)

• adhesive capsulitis, or cervical radiculopathy

• a history of shoulder injury or surgery or orthopedic or neurologic disorders (other than SCI) that would impact arm function

Related Conditions & MeSH terms

• Shoulder Pain
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Other:
• Shoulder home exercise program
Patients receive instruction and practice on the shoulder home exercise program, receive a notebook with handouts including pictures and written instructions on how to perform the program, and receive a kit containing the exercise equipment. Patients are asked to perform the exercises at home 3 days a week over the next 3 years.

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehabilitaiton Center	Downey	California

Sponsors (2)

Lead Sponsor	Collaborator
Rancho Research Institute, Inc.	Rancho Los Amigos National Rehabilitation Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Shoulder torque	Shoulder torque testing will be performed using either a Biodex machine or a handheld dynamometer for the motions of isometric shoulder abduction, adduction, flexion, extension, internal rotation and external rotation.	Baseline, 18 month, and 36 month evaluation time points
Other	Self-Efficacy	Patients will complete a questionnaire rating their confidence or self-efficacy in regards to exercise.	Baseline, 18 month and 36 month evaluation time points
Other	Community Participation	Patients will asked to complete the questionnaire, "Reintegration To Normal Living Index".	Baseline, 18 month and 36 month evaluation time points
Primary	Presence of shoulder pain	Presence of shoulder pain will be measured using the "Wheelchair User's Shoulder Pain Index". This questionnaire uses a visual analog scale to rate level of shoulder pain during the previous week while performing 15 common daily activities such as transferring from the bed to a wheelchair or pushing a wheelchair > 10 minutes.	36 month (3 year) evaluation time point
Secondary	Activity levels	Patients will be called every 2-3 months to report the frequency and intensity of their shoulder exercise program. Patients will be asked questions about their arm use specific to their functional abilities during the previous 1 to 3 days, such as the number of transfers performed, number of depression raises performed, how often they use their arms for chores or use their arms to help with walking (if applicable). All patients with a manual wheelchair will have an odometer installed on their wheelchair and will report their distance and speed of wheelchair propulsion.	Baseline and every 2-3 months over the 3 year study