Long-term Effect of Hypnosis in Spinal Cord Injury Patients

Spinal Cord Injuries Clinical Trial

Official title:

Long-term Effect of Hypnosis in Spinal Cord Injury Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03063333
• Other study ID #: 240929
• Status: Terminated
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2019
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Coping-oriented hypnosis
Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.
• Neutral hypnosis
Hypnosis using neutral suggestions plus current treatment

Locations

Country	Name	City	State
Denmark	Spinal Cord Injury Centre of Western Denmark	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Lone Knudsen, MSc Psych, PhD

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Kjøgx 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):1287-96. doi: 10.1097/j.pain.0000000000000519. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	patient report	For 14 days post-intervention
Primary	Pain intensity	NRS (0-10)	For 14 days post-intervention
Primary	Coping	Coping strategies questionnaire	For 14 days post-intervention
Secondary	Pain catastrophizing	Pain catastrophizing scale	For 14 days post-intervention
Secondary	Pain impact on mood, sleep and daily activities	NRS (0-10)	For 14 days post-intervention
Secondary	Anxiety	Hospital Anxiety and Depression Scale	For 14 days post-intervention
Secondary	Depression	Hospital Anxiety and Depression Scale	For 14 days post-intervention
Secondary	Global impression of change	Global impression of change scale	For 14 days post-intervention