Spinal Cord InjuriesNCT03063333
Long-term Effect of Hypnosis in Spinal Cord Injury Patients
A study testing Coping-oriented hypnosis and Neutral hypnosis in people with Spinal Cord Injuries, run by Lone Knudsen, MSc Psych, PhD at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Coping-oriented hypnosis and Neutral hypnosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- 17 May 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Coping-oriented hypnosis, Neutral hypnosis
- Keywords
- spinal cord injury, hypnosis, pain, pain catastrophizing, coping
- Medical subject headings
- Spinal Cord Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping-oriented hypnosisOther
Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.
Neutral hypnosisOther
Hypnosis using neutral suggestions plus current treatment
| Study group | Role | What they receive |
|---|---|---|
| Coping-oriented hypnosis | Experimental | Not described Receives: Other: Coping-oriented hypnosis |
| Neutral hypnosis | Placebo comparator | Not described Receives: Other: Neutral hypnosis |
| current treatment only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
NRS (0-10)
Measured: For 14 days post-intervention
Coping
Coping strategies questionnaire
Measured: For 14 days post-intervention
Secondary outcomes (5)
Pain catastrophizing
Pain catastrophizing scale
Measured: For 14 days post-intervention
Pain impact on mood, sleep and daily activities
NRS (0-10)
Measured: For 14 days post-intervention
Anxiety
Hospital Anxiety and Depression Scale
Measured: For 14 days post-intervention
Depression
Hospital Anxiety and Depression Scale
Measured: For 14 days post-intervention
Global impression of change
Global impression of change scale
Measured: For 14 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start17 May 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Why it stopped: Head of project stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lone Knudsen, MSc Psych, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lone Knudsen, MSc Psych, PhD, Central Jutland Regional Hospital
- Investigators
- Helge Kasch, MD, PhD, Study chair, Spinal Cord Injury Centre of Western Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063333
- Sponsor's protocol ID
- 240929
- Status last verified
- Dec 2019
- First submitted
- 21 Feb 2017
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26871534
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of Hypnosis in Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT03063333
- Acronym / sponsor ID
- 240929
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, hypnosis, pain, pain catastrophizing, coping
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Head of project stopped
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lone Knudsen, MSc Psych, PhDUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled study with three arms: coping-oriented hypnosis, neutral hypnosis, no hypnosis
| Arm | Type | Receives |
|---|---|---|
| Coping-oriented hypnosis | Experimental | Other: Coping-oriented hypnosis |
| Neutral hypnosis | Placebo comparator | Other: Neutral hypnosis |
| current treatment only | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping-oriented hypnosisHypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment. | Other | Coping-oriented hypnosis |
| Neutral hypnosisHypnosis using neutral suggestions plus current treatment | Other | Neutral hypnosis |
Primary outcome
Pain intensity
Time frame: For 14 days post-intervention
NRS (0-10)
Coping
Time frame: For 14 days post-intervention
Coping strategies questionnaire
5 secondary outcomes
Pain catastrophizing
Time frame: For 14 days post-intervention
Pain impact on mood, sleep and daily activities
Time frame: For 14 days post-intervention
Anxiety
Time frame: For 14 days post-intervention
Depression
Time frame: For 14 days post-intervention
Global impression of change
Time frame: For 14 days post-intervention
Results and safety
The study was stopped early (reason given: Head of project stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 26871534Kjogx 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge Kasch, MD, PhD study chair
Spinal Cord Injury Centre of Western Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping-oriented hypnosis and Neutral hypnosis in people with Spinal Cord Injuries, run by Lone Knudsen, MSc Psych, PhD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Head of project stopped). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: For 14 days post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03063333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.