Effect of Guided Imagery on Patients With Chronic Pain Related to Spinal Cord Injury - Full Text View

Sponsored by:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00678548

Purpose

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.

Condition	Intervention
Pain	Behavioral: Pleasant giuded imagery Behavioral: Pain diary

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Positive Guided Imagery on Patients With in or Below-Level Chronic Pain Related to Spinal Cord Injury

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Pain intensity, as measured by NRS and BPIQ [ Time Frame: NRS daily and BPIQ pre and post, (four weeks ) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BDI, BAI and SF36 [ Time Frame: pre and postintervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
A: Experimental CD	Behavioral: Pleasant giuded imagery CD with plesant guided imagery
B: Active Comparator Pain diary	Behavioral: Pain diary Filling out a pain diary

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678548

Contacts

Contact: Gunnar Leivseth, Professor MD

7257-5100

Gunnar.Leivseth@ntnu.no

Locations

Norway
St.Olavs Hospital, department for physical medicine and rehabilitation
Trondheim, Norway, 7489

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Principal Investigator:

Gunnar Leivseth, Professor MD

Norwegian University of Science and Technology

More Information

Responsible Party:	Nowegian University of Science and Technology ( Tom Torhaug, MD )
Study ID Numbers:	4.2007.1943
Study First Received:	May 13, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00678548
Health Authority:	Norway: Norwegian Social Science Data Services

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Pain
Trauma, Nervous System

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009