Association Between Types of Pain and Motor Activities Physical Activity

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236933
• Other study ID #: 27219
• Status: Completed
• Start date: March 24, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: March 2023
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity over 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.	Measured repeatedly at set intervals; at baseline, 15 minutes after baseline assessment, and once daily for 1 week
Secondary	Pain interference	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.	Measured once at baseline
Secondary	Depression	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.	Measured once at baseline
Secondary	Kinesiophobia	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.	Measured once at baseline
Secondary	Conditioned pain modulation	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).	Measured once at baseline
Secondary	Virtual embodiment	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.	Measured once at baseline