Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04991415 |
Other study ID # |
Manual Therapy |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 2014 |
Est. completion date |
July 2021 |
Study information
Verified date |
July 2021 |
Source |
Craig Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.