Clinical trial NCT03063333: 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
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
hypnosis
pain
pain catastrophizing
coping
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain intensity
timeFrame: For 14 days post-intervention
measure: Coping
timeFrame: For 14 days post-intervention
Secondary outcomes:
measure: Pain catastrophizing
timeFrame: For 14 days post-intervention
measure: Pain impact on mood, sleep and daily activities
timeFrame: For 14 days post-intervention
measure: Anxiety
timeFrame: For 14 days post-intervention
measure: Depression
timeFrame: For 14 days post-intervention
measure: Global impression of change
timeFrame: For 14 days post-intervention
Other outcomes:
measure: Side effects
timeFrame: For 14 days post-intervention
Locations:
city: Viborg
country: Denmark
facility: Spinal Cord Injury Centre of Western Denmark
Study officials:
affiliation: Spinal Cord Injury Centre of Western Denmark
name: Helge Kasch, MD, PhD
role: STUDY_CHAIR
References:
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.