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.

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Coping-oriented hypnosis; Other: Neutral hypnosis

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Viborg, Denmark, 8800
    • Spinal Cord Injury Centre of Western Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	patient report	For 14 days post-intervention

Collaborators and Investigators

• Sponsor: Lone Knudsen, MSc Psych, PhD
• Investigators: Study Chair: Helge Kasch, MD, PhD, Spinal Cord Injury Centre of Western Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2017
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (ACTUAL): February 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: pain; coping; spinal cord injury; hypnosis; pain catastrophizing
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 240929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No