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NCT Number: NCT05236933

Association Between Types of Pain and Motor Activities Physical Activity

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).

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Key information

Conditions

Spinal Cord Injury Behavior Central Nervous System Diseases Chronic Pain Motor Activity Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Temple University

Philadelphia, Pennsylvania, 19122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in pain intensity over 1 week

    Time frame: Measured repeatedly at set intervals; at baseline, 15 minutes after baseline assessment, and once daily for 1 week

    Patient-reported rating of pain intensity collected using the International SCI Pain Basic Data Set Version 2.0 (Widerstrom-Noga et al., 2014). This measure provides information regarding the location and severity of pain on a 0-10 scale, where higher number indicates worse pain, and categorization of pain into neuropathic and nociceptive.

Secondary outcomes

  1. Pain interference

    Time frame: Measured once at baseline

    Pain interference will be collected using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 8a V1.0 (Amtmann et al., 2010). Pain interference is a measure of consequences of pain, rather than intensity. It incorporates aspects of pain associated with quality of life and physical functioning. A 5-point Likert scale for eight items provides a score ranging from 8-40, where a higher score indicates greater pain interference.

  2. Depression

    Time frame: Measured once at baseline

    Depression will be measured using the Patient Health Questionnaire to examine its effect as a potential confounder in the interaction between physical activity and pain. This measure implements a 4-point Likert scale for nine items to calculate a score ranging from 0-27, with 0 indicating no depression and 27 indicating severe depression.

  3. Kinesiophobia

    Time frame: Measured once at baseline

    The Tampa Scale for Kinesiophobia will be used in assessing kinesiophobia, which will assist in identifying if it is a confounder. This 17-item measure uses a 4-point Likert scale to calculate a score between 17-68, where higher scores indicate greater fear of movement.

  4. Conditioned pain modulation

    Time frame: Measured once at baseline

    Conditioned pain modulation (CPM) is used to assess endogenous pain inhibition mechanisms. The outcome of CPM testing is either a normal effect or an abnormal effect. Abnormal CPM effect, which is an increased pain threshold after a conditioning stimulus, is an important biomarker of chronic pain (Fernandes et al., 2019).

  5. Virtual embodiment

    Time frame: Measured once at baseline

    The Virtual Embodiment Questionnaire (Roth & Latoschik, 2020) will be used to assess embodiment with the avatar while in the immersive VR environment. This measure uses a 7-point Likert scale to calculate a score ranging from 4-28 in each of three sections that assess body ownership of the avatar, control and agency of the avatar, and sensation of body changes with the avatar. A higher score in each section indicates increased ownership, increased control, and increased body change, respectively.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

Association Between Types of Pain and Motor Activities Physical Activity in Individuals With Spinal Cord Injury

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2022
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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