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Effect of Guided Imagery on Patients With Chronic Pain Related to Spinal Cord Injury

This study has suspended participant recruitment.
(Due to other projects priority)
Sponsor:
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00678548
First received: May 13, 2008
Last updated: March 10, 2009
Last verified: March 2009
History of Changes
  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 guided imagery
Behavioral: Pain diary

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Positive Guided Imagery on Patients With in or Below-Level Chronic Pain Related to Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

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 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
CD
 Behavioral: Pleasant guided imagery
CD with pleasant guided imagery
Active Comparator: B
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

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

No publications provided

Responsible Party: Tom Torhaug, MD, Nowegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00678548     History of Changes
Other Study ID Numbers: 4.2007.1943
Study First Received: May 13, 2008
Last Updated: March 10, 2009
Health Authority: Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013