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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03063333
Other study ID # 240929
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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