Chronic PainPhase 1/2NCT02561676
Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education
A Phase 1/2 study testing Education Program Type 1 and Education Program Type 2 in people with Chronic Pain and Spinal Cord Injuries, run by Kessler Foundation at 1 site in United States.
Trial summary
Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI). The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Spinal Cord Injuries
- What is being tested?
- Education Program Type 1 and Education Program Type 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 31 Dec 2019
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCI for at least one year
- Chronic pain for at least three months that is moderate to severe
- Fluent in English
- Not currently starting a new pain treatment or changing a previous pain treatment
Who cannot join
- Lack of access to a computer with high-speed internet access, at home or another location
- Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect physical or mental functioning
- Significant difficulties with learning or memory
- Previous participation in a health and function education program specifically designed for people with chronic pain and SCI
- Inability to understand English well
- Other conditions not related to SCI that cause pain (such as fibromyalgia)
Trial locations and contacts
1 site in 1 country.
About this study
Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI).
The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.
Read the detailed description
Chronic pain (pain that is present for a long period of time) is common among people with spinal cord injury (SCI). The pain is often severe and can affect daily activities. Unfortunately, common treatments such as medications provide incomplete relief from chronic pain. Thus, persons with SCI have to find alternate ways to live a happy, healthy, and productive life, even with some pain.
The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.
- Conditions
- Chronic Pain, Spinal Cord Injuries
- Being tested
- Education Program Type 1, Education Program Type 2
- Keywords
- Mindfulness, Spinal Cord Injury
- Medical subject headings
- Chronic Pain, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Program Type 1Other
The classes will discuss topics related to health and functioning of people with spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.
Education Program Type 2Other
The classes will discuss topics related to health and functioning of people with spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based Education Program Type 1 | Experimental | The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day. Receives: Other: Education Program Type 1 |
| Web-Based Education Program Type 2 | Experimental | The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day. Receives: Other: Education Program Type 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS). The MPI-LIS is a self-report of extent of interference of pain with life activities and the enjoyment of life. The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.
Measured: Average of scores obtained during baseline (Week 1 and Week 2) compared to scores obtained during Week 12 (the week in which the program is completed)
Secondary outcomes (7)
Change in pain intensity rated on a 0-10 numerical rating scale
Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").
Measured: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Brief Patient Health Questionnaire scores
The Brief Patient Health Questionnaire will be used to assess changes in mental health before and after participation in the education program.
Measured: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Mental Health Subscale of the SF-36 scores
The Mental Health Subscale of the SF-36 will be used to assess changes in mental health and well-being before and after participation in the education program.
Measured: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Survey of Pain Attitudes scores
The Survey of Pain Attitudes will be used to assess thoughts and feelings about pain before and after participation in the education program.
Measured: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Coping Strategies Questionnaire scores
The Coping Strategies Questionnaire will be used to assess thoughts and feelings about pain before and after participation in the education program.
Measured: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Chronic Pain Acceptance Questionnaire scores
The Chronic Pain Acceptance Questionnaire will be used to assess thoughts and beliefs about pain before and after participation in the education program.
Measured: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Pain interference with activities, measured with the Life Interference Subscale of the Change in Multidimensional Pain Inventory (MPI-LIS) scores
The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS). The MPI-LIS is a self-report of extent of interference of pain with life activities and the enjoyment of life. The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.
Measured: 3, 6, 12 months post-intervention versus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startMar 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- eMindful.com
- Responsible party
- Sponsor
- Investigators
- Jeanne M Zanca, PhD, MPT, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561676
- Sponsor's protocol ID
- R-860-14
- Status last verified
- May 2020
- First submitted
- 11 Feb 2015
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education
- ClinicalTrials.gov ID
- NCT02561676
- Acronym / sponsor ID
- R-860-14
- Conditions
- Chronic Pain, Spinal Cord Injuries
- Keywords
- Mindfulness, Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- eMindful.com
- Study start
- Mar 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Sep 2015 (estimated)
- 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.
Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI).
The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.
Detailed description
Chronic pain (pain that is present for a long period of time) is common among people with spinal cord injury (SCI). The pain is often severe and can affect daily activities. Unfortunately, common treatments such as medications provide incomplete relief from chronic pain. Thus, persons with SCI have to find alternate ways to live a happy, healthy, and productive life, even with some pain.
The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-Based Education Program Type 1 | Experimental | Other: Education Program Type 1The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day. |
| Web-Based Education Program Type 2 | Experimental | Other: Education Program Type 2The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- SCI for at least one year
- Chronic pain for at least three months that is moderate to severe
- Fluent in English
- Not currently starting a new pain treatment or changing a previous pain treatment
Key exclusion criteria (6 listed)
- Lack of access to a computer with high-speed internet access, at home or another location
- Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect physical or mental functioning
- Significant difficulties with learning or memory
- Previous participation in a health and function education program specifically designed for people with chronic pain and SCI
- Inability to understand English well
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education Program Type 1The classes will discuss topics related to health and functioning of people with spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class. | Other | Web-Based Education Program Type 1 |
| Education Program Type 2The classes will discuss topics related to health and functioning of people with spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class. | Other | Web-Based Education Program Type 2 |
Primary outcome
Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
Time frame: Average of scores obtained during baseline (Week 1 and Week 2) compared to scores obtained during Week 12 (the week in which the program is completed)
The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS). The MPI-LIS is a self-report of extent of interference of pain with life activities and the enjoyment of life. The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.
7 secondary outcomes
Change in pain intensity rated on a 0-10 numerical rating scale
Time frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Brief Patient Health Questionnaire scores
Time frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Mental Health Subscale of the SF-36 scores
Time frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Survey of Pain Attitudes scores
Time frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Coping Strategies Questionnaire scores
Time frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Chronic Pain Acceptance Questionnaire scores
Time frame: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Pain interference with activities, measured with the Life Interference Subscale of the Change in Multidimensional Pain Inventory (MPI-LIS) scores
Time frame: 3, 6, 12 months post-intervention versus 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 12 May 2020.
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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.
Jeanne M Zanca, PhD, MPT principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Education Program Type 1 and Education Program Type 2 in people with Chronic Pain and Spinal Cord Injuries, run by Kessler Foundation 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 6 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 12 May 2020. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS) (time frame: Average of scores obtained during baseline (Week 1 and Week 2) compared to scores obtained during Week 12 (the week in which the program is completed)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2020.