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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00678548
Other study ID # 4.2007.1943
Secondary ID
Status Withdrawn
Phase N/A
First received May 13, 2008
Last updated April 7, 2015
Start date October 2008
Est. completion date March 2009

Study information

Verified date April 2015
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Traumatic and non traumatic SCI (spinal cord injury) persons in Trøndelag (Norway)

Exclusion Criteria:

- Not sufficient knowledge of the Norwegian language, cancer, serious cognitive impairment, abuse or dependence of alcohol, narcotics or analgesics and dissociative disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Pleasant guided imagery
CD with pleasant guided imagery
Pain diary
Filling out a pain diary

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity as measured by a numerical rating scale (daily) and Brief pain questionnaire (BPI) (baseline and after 4 weeks) four weeks No
Secondary BDI, BAI and SF36 pre and postintervention No
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