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Long-term Effect of Hypnosis in Spinal Cord Injury Patients

NCT ID: NCT03063333

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2019-11-01

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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Keywords

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spinal cord injury hypnosis pain pain catastrophizing coping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Coping-oriented hypnosis

Group Type EXPERIMENTAL

Coping-oriented hypnosis

Intervention Type OTHER

Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.

Neutral hypnosis

Group Type PLACEBO_COMPARATOR

Neutral hypnosis

Intervention Type OTHER

Hypnosis using neutral suggestions plus current treatment

current treatment only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Coping-oriented hypnosis

Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.

Intervention Type OTHER

Neutral hypnosis

Hypnosis using neutral suggestions plus current treatment

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lone Knudsen, MSc Psych, PhD

OTHER

Sponsor Role lead

Responsible Party

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Lone Knudsen, MSc Psych, PhD

Psychologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Helge Kasch, MD, PhD

Role: STUDY_CHAIR

Spinal Cord Injury Centre of Western Denmark

Locations

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Spinal Cord Injury Centre of Western Denmark

Viborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 26871534 (View on PubMed)

Other Identifiers

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240929

Identifier Type: -

Identifier Source: org_study_id