Manual Therapy for the Treatment of Shoulder Pain for Overuse Syndrome Wheelchair Dependent Persons (MTX)
Primary Purpose
Spinal Cord Injuries, Pain, Musculoskeletal Manipulations
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility 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.
Sites / Locations
- Craig Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
30 minutes of manual therapy three times a week for two weeks (six total sessions).
No intervention
Outcomes
Primary Outcome Measures
Change in Wheelchair Users Shoulder Pain Index (WUSPI)
WUSPI collected at baseline (before treatment) and two weeks (after treatment)
Secondary Outcome Measures
Change in Numerical Pain Rating Scale (NPRS)
NPRS collected at baseline (before treatment) and two weeks (after treatment)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04991415
Brief Title
Manual Therapy for the Treatment of Shoulder Pain for Overuse Syndrome Wheelchair Dependent Persons
Acronym
MTX
Official Title
Manual Therapy for the Treatment of Shoulder Pain for Overuse Syndrome Wheelchair Dependent Persons
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
July 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Craig Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Pain, Musculoskeletal Manipulations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
30 minutes of manual therapy three times a week for two weeks (six total sessions).
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Primary Outcome Measure Information:
Title
Change in Wheelchair Users Shoulder Pain Index (WUSPI)
Description
WUSPI collected at baseline (before treatment) and two weeks (after treatment)
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Change in Numerical Pain Rating Scale (NPRS)
Description
NPRS collected at baseline (before treatment) and two weeks (after treatment)
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Berliner, DO
Organizational Affiliation
Physician, Director of Outpatient Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Manual Therapy for the Treatment of Shoulder Pain for Overuse Syndrome Wheelchair Dependent Persons
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