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Multiple SclerosisPOPNCT01800604

Power Over Pain (POP) Study

A study testing Pain Self-Management Intervention #1, Pain Self-Management Intervention #2 and Pain Self-Management Intervention #3 in people with Multiple Sclerosis and Spinal Cord Injury, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many individuals with multiple sclerosis (MS), spinal cord injury (SCI), acquired amputation (AMP), muscular dystrophy (MD), and low back pain (LBP) experience pain. There has been little research on how to treat this pain. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pain Self-Management Intervention #1, Pain Self-Management Intervention #2 and Pain Self-Management Intervention #3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
1 siteUnited States
Study dates
Feb 2013to Jan 2018
Phase
Interventional
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

  • 18 years of age or older;
  • diagnosis of SCI, MS, AMP, MD or LBP
  • moderate to severe chronic pain possibly related to MS, SCI, AMP, MD, or LBP that is persistent in nature;
  • able to read, speak, and understand English.

Who cannot join

  • severe cognitive impairment defined as two or more errors on the Six-Item Screen;
  • psychiatric condition or symptoms that would interfere with participation;
  • Pre-existing medical conditions that might interfere with EEG assessments.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington, Ninth and Jefferson Building

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Psychological Treatment of Disability-Related Pain: Efficacy and Mechanisms

Many individuals with multiple sclerosis (MS), spinal cord injury (SCI), acquired amputation (AMP), muscular dystrophy (MD), and low back pain (LBP) experience pain. There has been little research on how to treat this pain. Different types of treatment that include self-hypnosis, education about chronic pain, and learning skills on how to change how a person thinks about his/her pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these different treatments can help decrease pain in people with multiple sclerosis and spinal cord injury, and determine how and why these treatments are effective. A subject must have a diagnosis of MS,SCI, AMP, MD, or LBP, have chronic pain, and be at least 18 years old to participate.

Read the detailed description

Individuals from the study's recruitment sources with the diagnoses listed above will be contacted by research staff via telephone and invited to be screened for participation. In addition, individuals interested in participating may contact research staff upon learning about the study through a description listed on an approved website or a referral. Research staff will use a recruitment script for purposes of screening subjects and explaining the study. In addition, the initial screening process will also include conducting a cognitive screening known as the 6-item cognitive screener.

Research staff will verify the diagnoses (MS, SCI, AMP, MD or LBP) of prospective subjects who have not been 'pre-verified' in one of three ways during the recruitment process:

  1. Research staff will attempt to determine whether a subject from has a University of Washington Medical Center (UWMC)/Harborview Medical Center (HMC) medical record by conducting a simple search using a secure application. If research staff are unable to locate a medical record for the prospective subject from recruitment strategy #1, or if the individual is part of recruitment strategy #4 (i.e. if individual sees description of study on clinicaltrials.gov and contacts research staff), then one of two options will be pursued:
  2. Subjects will be asked during the initial screening process if staff may review their medical records if they have received services at the UWMC/HMC since their diagnosis;
  3. Subjects will be asked during the initial screening process if staff may contact a physician of their choice to verify their diagnosis if (a) they have not received services at the UWMC/HMC since their diagnosis; (b) they refuse to give staff permission to review their UWMC/HMC medical records; or (c) staff for some reason cannot find a UWMC/HMC medical record despite the subject attesting to being a patient at one time at the UWMC/HMC and giving staff permission to review his/her records.

Only individuals whose diagnosis has been verified (either via medical record review prior to/during screening or through verification via the subject's physician depending on recruitment source) will proceed with the psychological screening assessment.

Once a prospective subject has been screened and deemed eligible to participate, research staff will arrange a time and date for all subjects recruited into the study to participate in a telephone psychological screening assessment with one of the study's licensed clinicians (Drs. Jensen, Ehde, Molton, or Dillworth) or senior fellow (Elena Mendoza, a clinical psychologist). The study clinician will ask potential subjects some questions to assess the presence of active suicidal ideation or paranoid thoughts using an assessment sheet. Individuals who do have these types of thoughts will not be eligible for the study. Individuals will be referred to a mental health professional if he or she needs immediate attention.

Research staff will then arrange a time with the subject to attend in person what we call the initial intake session. At the beginning of the initial intake session, research staff will review a consent form with the subject and answer any questions he/she may have. The subject will complete and sign the consent form if he/she would like to participate. If the subject decides to enroll in the study, he/she will then be asked to complete a set of tasks testing memory and processing speed, participate in a relaxation and hypnotic exercise, and provide basic demographic information, as well as information about diagnosis and pain problem(s) he/she experiences. The initial intake session will last about 1.5 hours depending on the subject's answers.

The subject will then participate in a brain activity assessment at the Integrated Brain Imaging Center (IBIC) at the University of Washington that will take about one hour to complete. The brain activity assessment consists of an electroencephalogram (EEG), which measures the electrical activity in the brain through electrodes placed on the scalp. There is no risk of electrical shock. Research staff will place a damp electrode net on the subject's head that contains the electrodes that will measure the subject's brain activity. EEG activity will be collected with the subject's eyes closed. The research staff member will collect the data and ask the subject to remain as still as possible during the assessment. A research staff member will ask the subject his/her pain intensity during and after the assessment.

Subjects will be randomly assigned (by chance, like flipping a coin) to one of four treatment interventions. All four treatment interventions involve educating subjects about pain, discussing the impact of pain, and discussing different ways to manage it in hopes of decreasing subjects' pain and its impact on their lives. Two treatment interventions will also involve self-hypnosis. During self-hypnosis, subjects learn to enter a state of focused attention, and then change how they experience pain. All four treatment interventions are called "self-management" approaches to pain management. All of these treatments are commonly used in pain clinics and have been used to treat pain in persons with MS and SCI. We are interested in comparing the four different approaches to treating chronic pain.

A research staff member will also contact each subject six times by telephone during his/her participation in the study to complete three short interviews or assessments, 3-5 minutes long, and one longer assessment, about 30-40 minutes long, in a period of one week. These assessments will be completed one week prior to treatment, about halfway through the treatment period, after the completion of treatment, and 3-, 6- and 12-months after the subject completes treatment. The three shorter assessments will include questions about pain intensity. The fourth longer assessment will include questions about such things as how the subject thinks about pain, treatments for pain the subject has received, medications or drugs the subject has used, and any depressive symptoms the subject may have experienced.

We will also ask each subject to participate in a brain activity assessment following the end of treatment. The brain activity will be done the same way as described earlier and will take place at the Integrated Brain Imaging Center at the University of Washington.

Being tested
Pain Self-Management Intervention #1, Pain Self-Management Intervention #2, Pain Self-Management Intervention #3, Pain Self-Management Intervention #4
Medical subject headings
Multiple Sclerosis, Spinal Cord Injuries, Chronic Pain, Muscular Dystrophies, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Self-Management Intervention #1Behavioural

    Pain Self-Management Intervention #1 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). The sessions will cover a variety of topics, including the definition of chronic pain, the physiological processes underlying chronic pain, common pain-related conditions such as sleep disturbance, and the effects of chronic pain. Participants will be encouraged to ask questions about and discuss the information presented during the treatment sessions.

  • Pain Self-Management Intervention #2Behavioural

    Pain Self-Management Intervention #2 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). Pain Self-Management Intervention #2 will emphasize cognitive restructuring skills to replace maladaptive pain-related thoughts with adaptive and reassuring ones. These skills include being able to: (1) develop awareness of one's thoughts; (2) identify and evaluate adaptive/helpful vs. unhelpful/maladaptive thoughts; and (3) develop alternative thoughts to maladaptive thoughts that are (a) realistic, (b) accurate, (c) reassuring, and (d) facilitate positive outcomes.

  • Pain Self-Management Intervention #3Behavioural

    Pain Self-Management Intervention #3 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). In Pain Self-Management Intervention #3, subjects will relax in a comfortable position with their eyes closed and simply listen to the clinician speak. The clinician will begin the session with a hypnotic induction focusing on being aware of sensations of relaxation, followed by suggestions for decreases in pain intensity and alterations in the sensory experience of "what are sometimes uncomfortable sensations" so that they are more comfortable.

  • Pain Self-Management Intervention #4Behavioural

    Pain Self-Management Intervention #4 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). Pain Self-Management Intervention #4 will use hypnotic strategies and suggestions for identifying adaptive cognitions and for making adaptive changes in cognitions more integrated into a participant's belief system.

Study groups in NCT01800604
Study groupRoleWhat they receive
Pain Self-Management Arm #1ExperimentalPain Self-Management Intervention #1
Receives: Behavioral: Pain Self-Management Intervention #1
Pain Self-Management Arm #2ExperimentalPain Self-Management Intervention #2
Receives: Behavioral: Pain Self-Management Intervention #2
Pain Self-Management Arm #3ExperimentalPain Self-Management Intervention #3
Receives: Behavioral: Pain Self-Management Intervention #3
Pain Self-Management Arm #4ExperimentalPain Self-Management Intervention #4
Receives: Behavioral: Pain Self-Management Intervention #4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in average pain intensity pre-treatment to post-treatment

    Average pain intensity will be assessed via telephone interviews using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours, four times within a 1-week period at each assessment point. The change in mean of these ratings will be used as the primary outcome measure of average daily pain intensity.

    Measured: Pre-treatment, Mid-treatment, Post-treatment, 3-,6-, and 12 months following end of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionJan 2018
  4. Study completionJan 2018

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01800604
Sponsor's protocol ID
43605
Other IDs
1R01HD070973
Acronym
POP
Status last verified
Oct 2018
First submitted
8 Feb 2013
Last updated
17 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • de la Vega R, Sakulsriprasert P, Miro J, Jensen MP. Optimizing Pain Intensity Assessment in Clinical Trials: How Many Ratings are Needed to Best Balance the Need for Validity and to Minimize Assessment Burden? J Pain. 2024 Jul;25(7):104474. doi: 10.1016/j.jpain.2024.01.339. Epub 2024 Jan 15.

    PubMed 38232864

Questions about this trial

What is this clinical trial studying?

A study testing Pain Self-Management Intervention #1, Pain Self-Management Intervention #2 and Pain Self-Management Intervention #3 in people with Multiple Sclerosis and Spinal Cord Injury, run by University of Washington 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 3 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 17 Oct 2018. 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 average pain intensity pre-treatment to post-treatment (time frame: Pre-treatment, Mid-treatment, Post-treatment, 3-,6-, and 12 months following end of treatment.). 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 NCT01800604, 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 17 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.

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