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Long-term Effect of Hypnosis in Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT03063333
Recruitment Status : Not yet recruiting
First Posted : February 24, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):

February 21, 2017
February 24, 2017
May 18, 2017
May 18, 2017
December 31, 2019   (Final data collection date for primary outcome measure)
  • Pain intensity [ Time Frame: For 14 days post-intervention ]
    NRS (0-10)
  • Coping [ Time Frame: For 14 days post-intervention ]
    Coping strategies questionnaire
Pain intensity [ Time Frame: For 14 days post-intervention ]
NRS (0-10)
Complete list of historical versions of study NCT03063333 on ClinicalTrials.gov Archive Site
  • Pain catastrophizing [ Time Frame: For 14 days post-intervention ]
    Pain catastrophizing scale
  • Pain impact on mood, sleep and daily activities [ Time Frame: For 14 days post-intervention ]
    NRS (0-10)
  • Anxiety [ Time Frame: For 14 days post-intervention ]
    Hospital Anxiety and Depression Scale
  • Depression [ Time Frame: For 14 days post-intervention ]
    Hospital Anxiety and Depression Scale
  • Global impression of change [ Time Frame: For 14 days post-intervention ]
    Global impression of change scale
  • Coping [ Time Frame: For 14 days post-intervention ]
    Coping Strategies Questionnaire
  • Pain catastrophizing [ Time Frame: For 14 days post-intervention ]
    Pain catastrophizing scale
  • Pain impact on mood, sleep and daily activities [ Time Frame: For 14 days post-intervention ]
    NRS (0-10)
  • Anxiety [ Time Frame: For 14 days post-intervention ]
    Hospital Anxiety and Depression Scale
  • Depression [ Time Frame: For 14 days post-intervention ]
    Hospital Anxiety and Depression Scale
  • Global impression of change [ Time Frame: For 14 days post-intervention ]
    Global impression of change scale
Side effects [ Time Frame: For 14 days post-intervention ]
patient report
Same as current
 
Long-term Effect of Hypnosis in Spinal Cord Injury Patients
Long-term Effect of Hypnosis in Spinal Cord Injury Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Spinal Cord Injuries
  • Other: Coping-oriented hypnosis
    Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.
  • Other: Neutral hypnosis
    Hypnosis using neutral suggestions plus current treatment
  • Experimental: Coping-oriented hypnosis
    Intervention: Other: Coping-oriented hypnosis
  • Placebo Comparator: Neutral hypnosis
    Intervention: Other: Neutral hypnosis
  • No Intervention: current treatment only
Kjøgx 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):1287-96. doi: 10.1097/j.pain.0000000000000519.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
75
December 31, 2019
December 31, 2019   (Final data collection date for primary outcome measure)

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.
  • Pain Catastrophizing Scale score between 16 and 35.

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Lone Knudsen, PhD +4578446163 lonknuds@rm.dk
Not Provided
 
 
NCT03063333
240929
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Lone Knudsen, MSc Psych, PhD, Central Jutland Regional Hospital
Lone Knudsen, MSc Psych, PhD
Not Provided
Study Chair: Helge Kasch, MD, PhD Spinal Cord Injury Centre of Western Denmark
Central Jutland Regional Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP