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Long-term Effect of Hypnosis in Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT03063333
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Lone Knudsen, MSc Psych, PhD, Central Jutland Regional Hospital

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Coping-oriented hypnosis Other: Neutral hypnosis Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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
Official Title: Long-term Effect of Hypnosis in Spinal Cord Injury Patients
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Coping-oriented hypnosis Other: Coping-oriented hypnosis
Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.
Placebo Comparator: Neutral hypnosis Other: Neutral hypnosis
Hypnosis using neutral suggestions plus current treatment
No Intervention: current treatment only



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: For 14 days post-intervention ]
    NRS (0-10)

  2. Coping [ Time Frame: For 14 days post-intervention ]
    Coping strategies questionnaire


Secondary Outcome Measures :
  1. Pain catastrophizing [ Time Frame: For 14 days post-intervention ]
    Pain catastrophizing scale

  2. Pain impact on mood, sleep and daily activities [ Time Frame: For 14 days post-intervention ]
    NRS (0-10)

  3. Anxiety [ Time Frame: For 14 days post-intervention ]
    Hospital Anxiety and Depression Scale

  4. Depression [ Time Frame: For 14 days post-intervention ]
    Hospital Anxiety and Depression Scale

  5. Global impression of change [ Time Frame: For 14 days post-intervention ]
    Global impression of change scale


Other Outcome Measures:
  1. Side effects [ Time Frame: For 14 days post-intervention ]
    patient report



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063333


Contacts
Contact: Lone Knudsen, PhD +4578446163 lonknuds@rm.dk

Locations
Denmark
Spinal Cord Injury Centre of Western Denmark Recruiting
Viborg, Denmark, 8800
Contact: Lone Knudsen, MScPsych PhD    +4578446163    lonknuds@rm.dk   
Sponsors and Collaborators
Lone Knudsen, MSc Psych, PhD
Investigators
Study Chair: Helge Kasch, MD, PhD Spinal Cord Injury Centre of Western Denmark

Publications:
Responsible Party: Lone Knudsen, MSc Psych, PhD, Psychologist, Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT03063333     History of Changes
Other Study ID Numbers: 240929
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lone Knudsen, MSc Psych, PhD, Central Jutland Regional Hospital:
spinal cord injury
hypnosis
pain
pain catastrophizing
coping

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