NCT00678548

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable pain

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

May 13, 2008

Last Update Submit

April 7, 2015

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    as measured by a numerical rating scale (daily) and Brief pain questionnaire (BPI) (baseline and after 4 weeks)

    four weeks

Secondary Outcomes (1)

  • BDI, BAI and SF36

    pre and postintervention

Study Arms (2)

guided imagery

EXPERIMENTAL

CD

Behavioral: Pleasant guided imagery

pain diary

ACTIVE COMPARATOR

Pain diary

Behavioral: Pain diary

Interventions

Pleasant guided imageryBEHAVIORAL

CD with pleasant guided imagery

guided imagery
Pain diaryBEHAVIORAL

Filling out a pain diary

pain diary

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gunnar Leivseth, Professor MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2008

First Posted

May 15, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 8, 2015

Record last verified: 2015-04