Spinal Cord InjuryNCT05236933
Association Between Types of Pain and Motor Activities Physical Activity
An observational study of Spinal Cord Injury and Chronic Pain, run by Temple University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury, Chronic Pain
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2022to 15 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- History of motion sickness or epilepsy
- Condition in which PA is medically contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Types of Pain and Motor Activities Physical Activity in Individuals With Spinal Cord Injury
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).
Read the 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.
- Conditions
- Spinal Cord Injury, Chronic Pain
- Keywords
- physical activity, virtual reality, nociceptive pain, neuropathic pain
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain, Motor Activity, Nociceptive Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neuropathic | Individuals who report pain that is categorized as neuropathic will be assigned to this group. | |
| Nociceptive | Individuals who report pain that is categorized as nociceptive will be assigned to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured repeatedly at set intervals; at baseline, 15 minutes after baseline assessment, and once daily for 1 week
Secondary outcomes (5)
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: Measured once at baseline
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: Measured once at baseline
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: Measured once at baseline
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: Measured once at baseline
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: Measured once at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start24 Mar 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236933
- Sponsor's protocol ID
- 27219
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Canori A, Coffman DL, Wright WG, Finley MA, Hiremath SV. Differential relationships between physical activity and pain phenotypes in individuals with spinal cord injury. J Spinal Cord Med. 2025 Jul;48(4):720-729. doi: 10.1080/10790268.2024.2344315. Epub 2024 Apr 25.
PubMed 38661677
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Types of Pain and Motor Activities Physical Activity in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05236933
- Acronym / sponsor ID
- 27219
- Conditions
- Spinal Cord Injury, Chronic Pain
- Keywords
- physical activity, virtual reality, nociceptive pain, neuropathic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuropathic | – | –Individuals who report pain that is categorized as neuropathic will be assigned to this group. |
| Nociceptive | – | –Individuals who report pain that is categorized as nociceptive will be assigned to this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- History of motion sickness or epilepsy
- Condition in which PA is medically contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Pain interference
Time frame: Measured once at baseline
Depression
Time frame: Measured once at baseline
Kinesiophobia
Time frame: Measured once at baseline
Conditioned pain modulation
Time frame: Measured once at baseline
Virtual embodiment
Time frame: Measured once at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 38661677Canori A, Coffman DL, Wright WG, Finley MA, Hiremath SV. Differential relationships between physical activity and pain phenotypes in individuals with spinal cord injury. J Spinal Cord Med. 2025 Jul;48(4):720-729. doi: 10.1080/10790268.2024.2344315. Epub 2024 Apr 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Chronic Pain, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05236933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.