Clinical trial NCT05236933: Association Between Types of Pain and Motor Activities Physical Activity
Official title: Association Between Types of Pain and Motor Activities Physical Activity in Individuals With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Chronic Pain
Keywords: physical activity
virtual reality
nociceptive pain
neuropathic pain
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with chronic SCI who live in the Greater Philadelphia region and have experienced chronic pain are eligible to participate in the study. Recruitment efforts will be targeted equally towards men and women of all races and ethnicities, however because SCI is more prevalent in men, we anticipate higher recruitment of men than women.

Brief summary: This study will investigate the relationships between: (1) physical activity (PA) and types of chronic pain (nociceptive and neuropathic), and (2) virtual reality (VR) and types of chronic pain (nociceptive and neuropathic).

Detailed description: Chronic pain can be differentiated by its underlying mechanisms. However, this important distinction is not applied to most non-pharmacological treatment approaches. Studies that have shown modulation of chronic pain with physical activity (PA) or virtual reality (VR) have not evaluated differential effects on nociceptive and neuropathic pain. Therefore, it is unknown if neuropathic pain and nociceptive pain respond differently to PA and VR, and if treatment could be optimized through targeted interventions or a combination of interventions. Understanding the relationships between different types of pain and motor activity will provide new insight to inform future recommendations to alter PA levels for pain modulation.

A prospective, cohort design will be employed for this study of individuals with SCI for a duration of one week in the community. This study will identify trends that are different between the responses of different types of pain and motor activities (i.e., PA and VR). The data obtained will also capture fluctuations in PA levels across participants and corresponding pain levels because PA levels will be collected through real-world data in the community.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of spinal cord injury (SCI) (at least six months post-SCI)
* Experienced chronic pain for a duration of at least 6 months
* Functionally able to self-propel a manual wheelchair
* Medically stable

Exclusion Criteria:

* History of motion sickness or epilepsy
* Condition in which PA is medically contraindicated

Primary outcomes:
measure: Change in pain intensity over 1 week
timeFrame: Measured repeatedly at set intervals; at baseline, 15 minutes after baseline assessment, and once daily for 1 week
Secondary outcomes:
measure: Pain interference
timeFrame: Measured once at baseline
measure: Depression
timeFrame: Measured once at baseline
measure: Kinesiophobia
timeFrame: Measured once at baseline
measure: Conditioned pain modulation
timeFrame: Measured once at baseline
measure: Virtual embodiment
timeFrame: Measured once at baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
References: