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Spinal Cord InjuriesMTXNCT04991415

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

A study testing Manual Therapy in people with Spinal Cord Injuries and Pain, run by Craig Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Manual Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Dec 2014to Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Craig Hospital

    Englewood, Colorado, 80113

Other trials in United States

About this study

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.

Read the 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.

Being tested
Manual Therapy
Medical subject headings
Spinal Cord Injuries, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04991415
Study groupRoleWhat they receive
TreatmentExperimental30 minutes of manual therapy three times a week for two weeks (six total sessions).
Receives: Other: Manual Therapy
ControlNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Wheelchair Users Shoulder Pain Index (WUSPI)

    WUSPI collected at baseline (before treatment) and two weeks (after treatment)

    Measured: Two weeks

Secondary outcomes (1)
  1. Change in Numerical Pain Rating Scale (NPRS)

    NPRS collected at baseline (before treatment) and two weeks (after treatment)

    Measured: Two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study startDec 2014
  3. Primary completionDec 2017
  4. Study completionJul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04991415
Sponsor's protocol ID
Manual Therapy
Acronym
MTX
Status last verified
Jul 2021
First submitted
20 Sep 2016
Last updated
5 Aug 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Manual Therapy in people with Spinal Cord Injuries and Pain, run by Craig Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Wheelchair Users Shoulder Pain Index (WUSPI) (time frame: Two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.

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