PainNCT00678548
Effect of Guided Imagery on Patients With Chronic Pain Related to Spinal Cord Injury
A study testing Pleasant guided imagery and Pain diary in people with Pain, run by Norwegian University of Science and Technology.
Trial summary
Chronic pain after spinal cord injury in or below the level of injury is a common problem and can be severe. The purpose of our study is to investigate the effect of pleasant guided imagery on spinal cord injured patients with chronic pain in or below the level of injury. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Pleasant guided imagery and Pain diary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Mar 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Traumatic and non traumatic SCI (spinal cord injury) persons in Trøndelag (Norway)
Who cannot join
- Not sufficient knowledge of the Norwegian language, cancer, serious cognitive impairment, abuse or dependence of alcohol, narcotics or analgesics and dissociative disorder
About this study
Official title: Effect of Positive Guided Imagery on Patients With in or Below-level Chronic Pain Related to Spinal Cord Injury
Chronic pain after spinal cord injury in or below the level of injury is a common problem and can be severe.
The purpose of our study is to investigate the effect of pleasant guided imagery on spinal cord injured patients with chronic pain in or below the level of injury.
Read the detailed description
The study is a controlled simple blind randomized prospective study. Subjects who live in Trøndelag ( Norway) and who have a traumatic or non traumatic spinal cord injury with chronic pain in or below the level of injury will be included in the study.
Assessments: Pain will be measured with NRS(numeric pain rating scale) and BPIQ (Brief pain intervention questionnaire), anxiety and depression with BDI and BAI (Beck's depression and anxiety inventory) and quality of live with SF36 health survey.
The subjects will be randomized in a treatment and control group. One group will use daily for four weeks a CD with a pleasant guided imagery, the other group will write a short pain diary.
The NRS will be registered daily and the other assessments before and after the interventions.
- Conditions
- Pain
- Being tested
- Pleasant guided imagery, Pain diary
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleasant guided imageryBehavioural
CD with pleasant guided imagery
Pain diaryBehavioural
Filling out a pain diary
| Study group | Role | What they receive |
|---|---|---|
| guided imagery | Experimental | CD Receives: Behavioral: Pleasant guided imagery |
| pain diary | Active comparator | Pain diary Receives: Behavioral: Pain diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
as measured by a numerical rating scale (daily) and Brief pain questionnaire (BPI) (baseline and after 4 weeks)
Measured: four weeks
Secondary outcomes (1)
BDI, BAI and SF36
Measured: pre and postintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Due to other projects priority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Leivseth, Professor MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678548
- Sponsor's protocol ID
- 4.2007.1943
- Status last verified
- Apr 2015
- First submitted
- 13 May 2008
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive Guided Imagery on Patients With in or Below-level Chronic Pain Related to Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00678548
- Acronym / sponsor ID
- 4.2007.1943
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to other projects priority
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 May 2008 (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 after spinal cord injury in or below the level of injury is a common problem and can be severe.
The purpose of our study is to investigate the effect of pleasant guided imagery on spinal cord injured patients with chronic pain in or below the level of injury.
Detailed description
The study is a controlled simple blind randomized prospective study. Subjects who live in Trøndelag ( Norway) and who have a traumatic or non traumatic spinal cord injury with chronic pain in or below the level of injury will be included in the study.
Assessments: Pain will be measured with NRS(numeric pain rating scale) and BPIQ (Brief pain intervention questionnaire), anxiety and depression with BDI and BAI (Beck's depression and anxiety inventory) and quality of live with SF36 health survey.
The subjects will be randomized in a treatment and control group. One group will use daily for four weeks a CD with a pleasant guided imagery, the other group will write a short pain diary.
The NRS will be registered daily and the other assessments before and after the interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| guided imagery | Experimental | Behavioral: Pleasant guided imageryCD |
| pain diary | Active comparator | Behavioral: Pain diaryPain diary |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Traumatic and non traumatic SCI (spinal cord injury) persons in Trøndelag (Norway)
Key exclusion criteria (1 listed)
- Not sufficient knowledge of the Norwegian language, cancer, serious cognitive impairment, abuse or dependence of alcohol, narcotics or analgesics and dissociative disorder
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 |
|---|---|---|
| Pleasant guided imageryCD with pleasant guided imagery | Behavioural | guided imagery |
| Pain diaryFilling out a pain diary | Behavioural | pain diary |
Primary outcome
Pain intensity
Time frame: four weeks
as measured by a numerical rating scale (daily) and Brief pain questionnaire (BPI) (baseline and after 4 weeks)
1 secondary outcome
BDI, BAI and SF36
Time frame: pre and postintervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
Gunnar Leivseth, Professor MD principal investigator
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Pleasant guided imagery and Pain diary in people with Pain, run by Norwegian University of Science and Technology.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 intensity (time frame: four weeks). 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 8 Apr 2015.