Long-term Effect of Hypnosis in Spinal Cord Injury Patients

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Effect of Hypnosis in Spinal Cord Injury Patients

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Coping-oriented hypnosis
* Other: Neutral hypnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | NRS (0-10) | For 14 days post-intervention | 
| Coping | Coping strategies questionnaire | For 14 days post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain catastrophizing | Pain catastrophizing scale | For 14 days post-intervention | 
| Pain impact on mood, sleep and daily activities | NRS (0-10) | For 14 days post-intervention | 
| Anxiety | Hospital Anxiety and Depression Scale | For 14 days post-intervention | 
| Depression | Hospital Anxiety and Depression Scale | For 14 days post-intervention | 
| Global impression of change | Global impression of change scale | For 14 days post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, spinal cord injury, hypnosis, pain catastrophizing, coping