Long-term Effect of Hypnosis in Spinal Cord Injury Patients
Primary Purpose
Spinal Cord Injuries
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Coping-oriented hypnosis
Neutral hypnosis
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, hypnosis, pain, pain catastrophizing, coping
Eligibility Criteria
Inclusion Criteria:
- Spinal cord injury (tetraplegia or paraplegia) with some preservation of hand functioning
- Baseline pain level of ≥ 3 on a Numeric Rating Scale (NRS; 0-10 where 10 is extremely severe pain)
- Pain duration of at least 8 weeks.
Exclusion Criteria:
- Severe mental or psychiatric illness
- Substance abuse (drugs, alcohol or medicine)
- Lack of ability to cooperate during the experiment
- Severe high cervical lesions
- Severe autonomic dysautonomia
Sites / Locations
- Spinal Cord Injury Centre of Western Denmark
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Coping-oriented hypnosis
Neutral hypnosis
current treatment only
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity
NRS (0-10)
Coping
Coping strategies questionnaire
Secondary Outcome Measures
Pain catastrophizing
Pain catastrophizing scale
Pain impact on mood, sleep and daily activities
NRS (0-10)
Anxiety
Hospital Anxiety and Depression Scale
Depression
Hospital Anxiety and Depression Scale
Global impression of change
Global impression of change scale
Full Information
NCT ID
NCT03063333
First Posted
February 21, 2017
Last Updated
December 10, 2019
Sponsor
Lone Knudsen, MSc Psych, PhD
1. Study Identification
Unique Protocol Identification Number
NCT03063333
Brief Title
Long-term Effect of Hypnosis in Spinal Cord Injury Patients
Official Title
Long-term Effect of Hypnosis in Spinal Cord Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Head of project stopped
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lone Knudsen, MSc Psych, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Coping-oriented hypnotic suggestions aimed at reducing pain catastrophizing was shown to reduce pain in people with chronic tension-type headache and experimental pain in healthy volunteers during hypnosis (Kjøgx et al., 2016). However, the duration of the effect on pain post-hypnosis is unknown.
The aim is to investigate the durational effect of a single session of coping-oriented hypnotic suggestions on chronic pain in patients with spinal cord injury. If effective for a longer period post-hypnosis, this form of hypnosis may provide an alternative to medicine or may be used in conjunction with lower medicine dosages.
Methods: 75 patients with spinal cord injury and pain is randomized into one of three conditions; coping-oriented hypnosis plus current treatment, neutral hypnosis plus current treatment or current treatment only. Pain intensity, coping strategies, pain catastrophizing, anxiety and depression is assessed before intervention and over a period of 14 days post-intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, hypnosis, pain, pain catastrophizing, coping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coping-oriented hypnosis
Arm Type
Experimental
Arm Title
Neutral hypnosis
Arm Type
Placebo Comparator
Arm Title
current treatment only
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Coping-oriented hypnosis
Intervention Description
Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.
Intervention Type
Other
Intervention Name(s)
Neutral hypnosis
Intervention Description
Hypnosis using neutral suggestions plus current treatment
Primary Outcome Measure Information:
Title
Pain intensity
Description
NRS (0-10)
Time Frame
For 14 days post-intervention
Title
Coping
Description
Coping strategies questionnaire
Time Frame
For 14 days post-intervention
Secondary Outcome Measure Information:
Title
Pain catastrophizing
Description
Pain catastrophizing scale
Time Frame
For 14 days post-intervention
Title
Pain impact on mood, sleep and daily activities
Description
NRS (0-10)
Time Frame
For 14 days post-intervention
Title
Anxiety
Description
Hospital Anxiety and Depression Scale
Time Frame
For 14 days post-intervention
Title
Depression
Description
Hospital Anxiety and Depression Scale
Time Frame
For 14 days post-intervention
Title
Global impression of change
Description
Global impression of change scale
Time Frame
For 14 days post-intervention
Other Pre-specified Outcome Measures:
Title
Side effects
Description
patient report
Time Frame
For 14 days post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spinal cord injury (tetraplegia or paraplegia) with some preservation of hand functioning
Baseline pain level of ≥ 3 on a Numeric Rating Scale (NRS; 0-10 where 10 is extremely severe pain)
Pain duration of at least 8 weeks.
Exclusion Criteria:
Severe mental or psychiatric illness
Substance abuse (drugs, alcohol or medicine)
Lack of ability to cooperate during the experiment
Severe high cervical lesions
Severe autonomic dysautonomia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helge Kasch, MD, PhD
Organizational Affiliation
Spinal Cord Injury Centre of Western Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Spinal Cord Injury Centre of Western Denmark
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26871534
Citation
Kjogx H, Kasch H, Zachariae R, Svensson P, Jensen TS, Vase L. Experimental manipulations of pain catastrophizing influence pain levels in patients with chronic pain and healthy volunteers. Pain. 2016 Jun;157(6):1287-1296. doi: 10.1097/j.pain.0000000000000519.
Results Reference
background
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Long-term Effect of Hypnosis in Spinal Cord Injury Patients
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