Manual Therapy for the Treatment of Shoulder Pain for Overuse Syndrome Wheelchair Dependent Persons (MTX)

• ClinicalTrials.gov Identifier: NCT04991415
• Recruitment Status: Completed
• First Posted: August 5, 2021
• Last Update Posted: August 5, 2021
• Sponsor: Craig Hospital
• Information provided by (Responsible Party): Jennifer Coker, Craig Hospital

Study Description

Brief Summary:

Shoulder pain is a common, debilitating problem for persons with Spinal cord injuries (SCI). Shoulder pain affects approximately 40-50% of the total population of persons with paraplegia (those with SCI with full use of their upper extremities and no or limited use of their lower extremities). Among the etiologies of shoulder pain in persons with paraplegia, overuse syndrome is the most common. Shoulder overuse syndrome in a person with paraplegia is the result of high activity demands and high mechanical load on the upper extremity during activities such as wheelchair propulsion, transferring with the arms, and performing activities of daily living from a wheelchair height, resulting in increased overhead activity. The pain as a result of overuse syndrome can limit the patient's participation in occupational and physical therapy as well as limit performance of activities of daily living and participation in usual life activities. An alternative treatment for shoulder pain with evidence to support efficacy in the able bodied population is Manual Therapy (MT). Unfortunately, there have been no prior research studies published examining the therapeutic efficacy of MT for overuse injuries of the shoulder in patients with paraplegia. This study will determine if MT, is efficacious to reduce pain in this population. A total of 20 patients with paraplegia identified in the outpatient clinic at Craig Hospital with overuse syndrome of the shoulder will be enrolled in the study.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries; Pain; Musculoskeletal Manipulations	Other: Manual Therapy	Not Applicable

Detailed Description:

Shoulder pain is a common, debilitating problem for persons with Spinal cord injuries (SCI). Shoulder pain affects approximately 40-50% of the total population of persons with paraplegia (those with SCI with full use of their upper extremities and no or limited use of their lower extremities). Among the etiologies of shoulder pain in persons with paraplegia, overuse syndrome is the most common. Shoulder overuse syndrome in a person with paraplegia is the result of high activity demands and high mechanical load on the upper extremity during activities such as wheelchair propulsion, transferring with the arms, and performing activities of daily living from a wheelchair height, resulting in increased overhead activity. The pain as a result of overuse syndrome can limit the patient's participation in occupational and physical therapy as well as limit performance of activities of daily living and participation in usual life activities.

In the able bodied population, the most common recommendation for overuse syndrome is resting the affected joint. In persons with paraplegia and wheelchair dependence, this recommendation is unrealistic and would lead to non-use of the person's primary means of mobility (the wheelchair). Often, patients require pharmacologic intervention to help alleviate the pain in order to participate in therapy sessions and activities of daily living. Current treatment options for overuse syndrome include oral medication including narcotic pain medication and anti-inflammatory medication, modalities, injections, and surgery. Despite these treatment options, pain from overuse syndrome remains a prevalent problem with no treatment option proven superior and no gold standard of treatment identified. An alternative treatment for shoulder pain with evidence to support efficacy in the able bodied population is Manual Therapy (MT). Unfortunately, there have been no prior research studies published examining the therapeutic efficacy of MT for overuse injuries of the shoulder in patients with paraplegia. This study will determine if MT, is efficacious to reduce pain in this population. A total of 20 patients with paraplegia identified in the outpatient clinic at Craig Hospital with overuse syndrome of the shoulder will be enrolled in the study. Ten of the participants will be randomized to the control group and receive no MT and ten participants will be randomized to the treatment group and receive MT for three days per week x 2weeks. The treatment will be provided by a Doctor of Osteopathic Medicine (D.O.), physical, or occupational therapists trained to perform MT. During this study, the subject's pain and function will be measured by a 10 point questionnaire, the Numeric Pain Rating Scale (NPRS) and the Wheelchair Users Shoulder Pain Index (WUSPI). The NPRS and WUSPI are included in Appendix 1 and 2. The NPRS has been validated as a ratio scale for pain. The WUSPI has been validated as a scale for assessment of baseline shoulder dysfunction and for periodic measurement in longitudinal studies of musculoskeletal complications in wheelchair users. Data gathered from these outcome measures will be accumulated and statistically analyzed to examine the potential benefit of MT in the target population. This investigation will be one of the first to examine the relationship between MT and reduction in shoulder pain for treatment of overuse syndrome in persons with paraplegia. It will also examine if decreased pain secondary to MT will result in a decrease in pain during functional activity in these individuals. The results of this pilot study may result in publication in peer reviewed journals, presentations at national symposiums and application for funding for Complementary Medicine grant by the National Institute of Health or other available grant for larger study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Manual Therapy for the Treatment of Shoulder Pain for Overuse Syndrome Wheelchair Dependent Persons
• Study Start Date: December 2014
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: July 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; 30 minutes of manual therapy three times a week for two weeks (six total sessions).	Other: Manual Therapy
No Intervention: Control; No intervention

Outcome Measures

Primary Outcome Measures :

1. Change in Wheelchair Users Shoulder Pain Index (WUSPI) [ Time Frame: Two weeks ]
   WUSPI collected at baseline (before treatment) and two weeks (after treatment)

Secondary Outcome Measures :

1. Change in Numerical Pain Rating Scale (NPRS) [ Time Frame: Two weeks ]
   NPRS collected at baseline (before treatment) and two weeks (after treatment)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age 18-65,
• Spinal cord injury, non-ambulatory, wheelchair user,
• Pain in shoulder from overuse injury,
• Pain interference on the WUSPI of at least 6/10 on at least 2 of the transfer items and any one of the remaining items,
• English-speaking,
• Stable spine,
• Full weight-bearing status in bilateral upper extremities (i.e. no orthopedic precautions on UE weight-bearing activities)
• Greater than 3 months post initial spinal cord injury
• Diagnosis of overuse syndrome of the shoulder

Exclusion Criteria:

• Concomitant moderate to severe Traumatic Brain Injury
• Fractures in upper limbs.
• Concurrent diagnosis of Fibromyalgia.
• Cervical radiculopathy.
• Previous shoulder pathology
• Neuromuscular junction disorders (such as myasthenia gravis),
• Psychiatric disorder.
• Lack capacity to provide informed consent.

Contacts and Locations

Locations

United States, Colorado

Craig Hospital

Englewood, Colorado, United States, 80113

Sponsors and Collaborators

Craig Hospital

Investigators

• Principal Investigator: Jeffrey Berliner, DO; Physician, Director of Outpatient Medicine

More Information

• Responsible Party: Jennifer Coker, Research Scientist I, Craig Hospital
• ClinicalTrials.gov Identifier: NCT04991415
• Other Study ID Numbers: Manual Therapy
• First Posted: August 5, 2021
• Last Update Posted: August 5, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Shoulder Pain; Spinal Cord Injuries; Cumulative Trauma Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Sprains and Strains