Long-term Effect of Hypnosis in Spinal Cord Injury Patients

NCT03063333 | Terminated DMC

• 1 other identifier: 240929
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; hypnosis; pain; pain catastrophizing; coping

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  NRS (0-10)

  For 14 days post-intervention

• Coping

  Coping strategies questionnaire

  For 14 days post-intervention

Secondary Outcomes (5)

• Pain catastrophizing

  For 14 days post-intervention

• Pain impact on mood, sleep and daily activities

  For 14 days post-intervention

• Anxiety

  For 14 days post-intervention

• Depression

  For 14 days post-intervention

• Global impression of change

  For 14 days post-intervention

Other Outcomes (1)

• Side effects

  For 14 days post-intervention

Study Arms (3)

Coping-oriented hypnosis

EXPERIMENTAL

Other: Coping-oriented hypnosis

Neutral hypnosis

PLACEBO COMPARATOR

Other: Neutral hypnosis

current treatment only

NO INTERVENTION

Interventions

Coping-oriented hypnosis OTHER

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

Coping-oriented hypnosis

Neutral hypnosis OTHER

Hypnosis using neutral suggestions plus current treatment

Neutral hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lone Knudsen, MSc Psych, PhD: lead

Study Sites (1)

Spinal Cord Injury Centre of Western Denmark

Viborg, 8800, Denmark

Location

Related Publications (1)

• 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.

  PMID: 26871534 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helge Kasch, MD, PhD

  Spinal Cord Injury Centre of Western Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychologist

Model Details: Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: May 17, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)