Maintenance of Shoulder Health and Function After Spinal Cord Injury

NCT02135978 | Completed

• 1 other identifier: H133N110018
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury; Shoulder Pain

Keywords

Spinal Cord Injury; Shoulder Pain; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Activity levels

  Baseline and every 2-3 months over the 3 year study

Other Outcomes (3)

• Shoulder torque

  Baseline, 18 month, and 36 month evaluation time points

• Self-Efficacy

  Baseline, 18 month and 36 month evaluation time points

• Community Participation

  Baseline, 18 month and 36 month evaluation time points

Study Arms (3)

One-to-one training group for shoulder home exercise program

EXPERIMENTAL

Patients will attend two sessions of one-to-one training with a physical therapist to learn the shoulder home exercise program. The sessions are 4 weeks apart. They will also review a handout on techniques to protect their shoulder during wheelchair propulsion and transfers.

Other: Shoulder home exercise program

Enhanced training group for shoulder home exercise program

ACTIVE COMPARATOR

Patients will attend four classes held each week for 4 consecutive weeks. The classes are led by a physical therapist and a peer mentor (with a spinal cord injury). Two to four research patients are in each class. Classes begin with an interactive education presentation on techniques and recommendations to protect the shoulder during transfers, wheelchair propulsion, raises and activities of daily living. This is followed by performance of the home exercise program. Patients will be called every 3 to 6 months by a peer mentor to receive encouragement, praise, and/or problem solve barriers to exercise.

Other: Shoulder home exercise program

Historical control group

NO INTERVENTION

Historical control group has received no intervention. Eligibility criteria, outcome measures and study duration for historical control group is matched for the experimental group and active comparator.

Interventions

Shoulder home exercise program OTHER

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.

Enhanced training group for shoulder home exercise program; One-to-one training group for shoulder home exercise program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rancho Research Institute, Inc.: lead
• Rancho Los Amigos National Rehabilitation Center: collaborator

Study Sites (1)

Rancho Los Amigos National Rehabilitaiton Center

Downey, California, 90242, United States

Location

Related 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.

  PMID: 21292803 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Shoulder Pain; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Sara J Mulroy, PhD, PT

  Rancho Research Institute and Rancho Los Amigos National Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, PT, Director Pathokinesiology Service

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 12, 2014
• Study Start: April 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

US (1)