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

NCT04991415 | Completed

• 1 other identifier: Manual Therapy
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Pain; Musculoskeletal Manipulations

Outcome Measures

Primary Outcomes (1)

• Change in Wheelchair Users Shoulder Pain Index (WUSPI)

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

  Two weeks

Secondary Outcomes (1)

• Change in Numerical Pain Rating Scale (NPRS)

  Two weeks

Study Arms (2)

Treatment

EXPERIMENTAL

30 minutes of manual therapy three times a week for two weeks (six total sessions).

Other: Manual Therapy

Control

NO INTERVENTION

No intervention

Interventions

Manual Therapy OTHER

Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jeffrey Berliner, DO

  Physician, Director of Outpatient Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist I

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: August 5, 2021
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-07

Locations

US (1)