Spinal Cord InjuryPhase 1/2NCT02262234
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
A Phase 1/2 study testing Education Program Type 1 and Education Program Type 2 in people with Spinal Cord Injury and Chronic Pain, 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). Unfortunately, chronic pain is very difficult to treat. Many treatments reduce chronic pain only partially. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Chronic Pain
- 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
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- 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
- Spinal cord injury for at least one year
- Chronic pain for at least three months that is moderate to severe (rated at or above 4/10 on a scale of 0 to 10 where 0 = "no pain" and 10 = "pain as bad as you can imagine")
- Fluent in English
- Not currently starting a new pain treatment or changing a previous pain treatment
Who cannot join
- Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect my 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
- Presence of 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). Unfortunately, chronic pain is very difficult to treat. Many treatments reduce chronic pain only partially. As a result, many people with SCI must find ways of accomplishing daily activities even though they have pain.
The purpose of this research study is to determine how well two different kinds of education programs reduce the extent to which chronic pain interferes with daily life and well-being.
Read the detailed description
Pain is a highly prevalent and disabling condition among persons with spinal cord injury (SCI). Unfortunately, current pain treatments offer incomplete relief, produce side effects, and/or involve significant cost. Low-risk, low-cost treatments capable of addressing residual pain and pain-related disability are greatly needed. A number of research studies have associated educational interventions with improvements in pain-related outcomes.
The overall goal of the proposed pilot study is to evaluate the feasibility, acceptability, and potential benefits of two types of educational programs for people with chronic pain and spinal cord injury. This study aims to identify a low-cost, low-risk treatment option that empowers people with pain and SCI to improve their functioning and quality of life.
- Conditions
- Spinal Cord Injury, Chronic Pain
- Being tested
- Education Program Type 1, Education Program Type 2
- Keywords
- Spinal cord injury, Chronic pain, Education
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Program Type 1Other
The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.
Education Program Type 2Other
The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.
| Study group | Role | What they receive |
|---|---|---|
| Education Program Type 1 | Experimental | Not described Receives: Other: Education Program Type 1 |
| Education Program Type 2 | Experimental | Not described Receives: Other: Education Program Type 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference with activities
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 10-item 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: Week 10 versus baseline
Secondary outcomes (3)
Pain intensity
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 10 versus baseline
Mental health and well-being
The Brief Patient Health Questionnaire and Perceived Stress Scale will be used to assess changes in mental health that occur between baseline and the end of the education program.
Measured: Week 10 versus baseline
Pain attitudes
The Survey of Pain Attitudes will be used to assess changes in thoughts and beliefs about pain.
Measured: Week 10 versus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Kessler Institute for Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Jeanne M Zanca, PhD, MPT, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262234
- Sponsor's protocol ID
- R-815-14
- Status last verified
- May 2020
- First submitted
- 7 Oct 2014
- 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
- Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
- ClinicalTrials.gov ID
- NCT02262234
- Acronym / sponsor ID
- R-815-14
- Conditions
- Spinal Cord Injury, Chronic Pain
- Keywords
- Spinal cord injury, Chronic pain, Education
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Kessler Institute for Rehabilitation
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Oct 2014 (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). Unfortunately, chronic pain is very difficult to treat. Many treatments reduce chronic pain only partially. As a result, many people with SCI must find ways of accomplishing daily activities even though they have pain.
The purpose of this research study is to determine how well two different kinds of education programs reduce the extent to which chronic pain interferes with daily life and well-being.
Detailed description
Pain is a highly prevalent and disabling condition among persons with spinal cord injury (SCI). Unfortunately, current pain treatments offer incomplete relief, produce side effects, and/or involve significant cost. Low-risk, low-cost treatments capable of addressing residual pain and pain-related disability are greatly needed. A number of research studies have associated educational interventions with improvements in pain-related outcomes.
The overall goal of the proposed pilot study is to evaluate the feasibility, acceptability, and potential benefits of two types of educational programs for people with chronic pain and spinal cord injury. This study aims to identify a low-cost, low-risk treatment option that empowers people with pain and SCI to improve their functioning and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Program Type 1 | Experimental | Other: Education Program Type 1 |
| Education Program Type 2 | Experimental | Other: Education Program Type 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spinal cord injury for at least one year
- Chronic pain for at least three months that is moderate to severe (rated at or above 4/10 on a scale of 0 to 10 where 0 = "no pain" and 10 = "pain as bad as you can imagine")
- Fluent in English
- Not currently starting a new pain treatment or changing a previous pain treatment
Key exclusion criteria (5 listed)
- Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect my 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
- Presence of other conditions not related to SCI that cause pain (such as fibromyalgia)
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 first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week. | Other | Education Program Type 1 |
| Education Program Type 2The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week. | Other | Education Program Type 2 |
Primary outcome
Pain interference with activities
Time frame: Week 10 versus baseline
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 10-item 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.
3 secondary outcomes
Pain intensity
Time frame: Week 10 versus baseline
Mental health and well-being
Time frame: Week 10 versus baseline
Pain attitudes
Time frame: Week 10 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.
- Kessler Foundation Home PageLink provided by the sponsor.
Related trials for Spinal Cord Injury
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Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
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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 Spinal Cord Injury and Chronic Pain, 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 5 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?
Pain interference with activities (time frame: Week 10 versus baseline). 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.