Clinical trial NCT04467749: Effects of In-Wheel Suspension
Official title: Effects of In-wheel Suspension in Reducing Vibration, Neck, and Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Fatigue
Back Pain
Neck Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2020-07-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Manual wheelchairs allow individuals with spinal cord injuries (SCI) to safely and effectively access their environment. However, continual exposure to whole body vibration (WBV) is one of many contributing factors to neck pain, back pain, and fatigue in wheelchair users with SCI.

Vibration-reducing in-wheel suspension has the potential to mitigate issues associated with long-term manual wheelchair propulsion. Evidence is lacking on how well these systems work for reducing harmful shock and vibration, pain and fatigue. The purpose of this study is to examine how these wheels change the vibration levels manual wheelchair users are exposed to and how they impact pain and fatigue.

Detailed description: Objective: The purpose of this project is to examine how Integral or in-wheel suspension impacts shock, vibration, pain and fatigue in manual wheelchair users with spinal cord injury who have chronic neck or back pain, defined as continuous or daily recurring pain that has been present for more than 3 months.

Experimental Design: This study consists of 2 phases. The first phase is a non-experimental post-test only design. The second phase is a non-experimental pretest-post-test design.

Methods: Thirty participants will be recruited to participate.

At Baseline (visit 1) participants will be asked to complete the study questionnaires and a standardized mobility course using a pair of standard wheelchair wheels (spoked rim), Spinergy lightweight carbon fiber wheels, and Loopwheels. Vibration exposure will be measured during the various propulsion tasks. The participant will be blinded to the type of wheel being used in the trial. Participants will be given a set of wheels (either Spinergy or Loopwheels) to use at home for the 12-week intervention.

Participants will use the in-wheel suspension wheels in their normal daily routine for 12-weeks. During this time, they will receive online surveys three times per week covering pain and fatigue experienced in various parts of the body.

At Closeout (Visit 2), participants will be asked to return to the lab to collect final outcomes, complete an exit survey and have their wheels swapped out for their original set.

Eligibility criteria: Inclusion Criteria:

* have neurological impairment secondary to a traumatic SCI
* have a SCI which occurred or was diagnosed over one year prior to the start of the study
* uses a manual wheelchair as a primary means of mobility (at least 30 hours per week but not necessarily always in motion)
* uses a manual wheelchair with 24- or 25-inch quick release wheels
* uses a manual wheelchair that does not have suspension elements in the frame,
* weighs under 265 pounds (maximum weight limit of the suspension wheels),
* has moderate chronic neck and/or back pain.
* proficient in English

Exclusion Criteria:

* History of fractures or dislocations in the shoulder, elbow and wrist from which the participant has not fully recovered (i.e. the participant may no longer experience pain or limited/altered function due to the injury)
* upper limb pain that interferes with the ability to propel,
* severe cognitive limitations,
* current or recent (within the last 6 months) history of pressure sores.

Primary outcomes:
measure: Vibrational Dose Value (VDV)
timeFrame: Baseline Visit (Phase 1 Primary Outcome)
measure: Changes in Neck Pain
timeFrame: Baseline and 12-weeks (Phase 2 Primary Outcome)
measure: Changes in Upper Back Pain
timeFrame: Baseline and 12-weeks (Phase 2 Primary Outcome)
measure: Changes in Fatigue
timeFrame: Baseline and 12-weeks (Phase 2 Primary Outcome)
Secondary outcomes:
measure: Changes in Mobility Participation in the Community
timeFrame: Baseline and 12-weeks (Phase 2 Secondary Outcome)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Alicia Koontz, PhD
role: PRINCIPAL_INVESTIGATOR
References: