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Low Back PainNCT04879394

Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

A study testing Hypnosis in people with Low Back Pain, run by University of Minho at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to characterize pain sensitivity and psychological profile of CLBP patients in comparison with pain free adults, and explore their predictive role on hypnosis outcomes, an effective intervention for pain control. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain
What is being tested?
Hypnosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 sitePortugal
Study dates
16 May 2022to Dec 2023
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • persistent or recurrent low back pain lasting over 3 months

Who cannot join

  • pain due to other causes (e.g. fibromyalgia, fracture)
  • back surgery in the previous 6 months or planned in the following 6 months
  • debilitating organic, psychiatric or neurological conditions (e.g. cancer, schizophrenia, dementia)
  • disability compensation or litigation related to CLBP
  • unavailability to commit to the hypnosis sessions.

Trial locations and contacts

1 site in 1 country.

Patrícia R Pinto, PhD contact

00351253604926

patipinto@gmail.com

Portugal1 site, 1 recruiting

  • Hospital de Braga

    Braga, 4710

    Joana Reis, +351 253 027 249

    Recruiting

Other trials in Portugal

About this study

Official title: Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients: Implications for a Personalized Treatment Approach

This study aims to characterize pain sensitivity and psychological profile of CLBP patients in comparison with pain free adults, and explore their predictive role on hypnosis outcomes, an effective intervention for pain control.

Read the detailed description

Chronic low back pain (CLBP) is a very prevalent condition, associated with high disability and financial costs. Pain sensitization and psychological status have been associated with symptom severity and treatment outcomes, but their prognostic value is not yet well established.

This is a Prospective Randomized Controlled Trial, with an experimental (hypnosis) and one control group (standard care), and 5 assessment points: baseline, post intervention, 1, 3 and 6 months follow-up. Participants will be 160 CLBP patients and 50 pain free adults, assessed on sociodemographic, clinical, pain, disability, psychophysical (Quantitative Sensory Testing) and psychological variables.

This work will contribute to a better knowledge of the mechanisms underlying CLBP and of the patient characteristics that can predict treatment outcomes after hypnosis. The findings have the potential to improve patient-targeted treatment approaches.

Conditions
Low Back Pain
Being tested
Hypnosis
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypnosisOther

    4 weekly hypnosis sessions, aiming at pain control and distress management. The 90 min. sessions will be conducted in group format by a doctorate-level psychologist trained in hypnosis. Contents will be detailed on hypnosis protocols to ensure standardization.

Study groups in NCT04879394
Study groupRoleWhat they receive
HypnosisExperimental4 weekly hypnosis sessions, aiming at pain control and distress management. The 90 min. sessions will be conducted in group format by a doctorate-level psychologist trained in hypnosis. Contents will be detailed on hypnosis protocols to ensure standardization.
Receives: Other: Hypnosis
ControlNo interventionReceives standard care as usual. Assessments will be made in the same time points as experimental group, but without undergoing intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)

    Pain intensity assessed by NRS

    Measured: 1 week post-intervention

  2. Pain intensity at 1 month as assessed by NRS

    Pain intensity assessed by NRS

    Measured: 1 month post-intervention

  3. Pain intensity at 3 months as assessed by NRS

    Pain intensity assessed by NRS

    Measured: 3 months post-intervention

  4. Pain intensity at 6 months as assessed by NRS

    Pain intensity assessed by NRS

    Measured: 6 months post-intervention

Secondary outcomes (24)

  1. Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI)

    Pain interference assessed by the BPI

    Measured: 1 week post-intervention

  2. Pain interference at 1 month as assessed by the BPI

    Pain interference assessed by the BPI

    Measured: 1 month post-intervention

  3. Pain interference at 3 months as assessed by the BPI

    Pain interference assessed by the BPI

    Measured: 3 months post-intervention

  4. Pain interference at 6 months as assessed by the BPI

    Pain interference assessed by the BPI

    Measured: 6 months post-intervention

  5. Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI)

    Functionality assessed by the ODI

    Measured: 1 week post-intervention

  6. Functionality at 1 month as assessed by the ODI

    Functionality as assessed by the ODI

    Measured: 1 month post-intervention

  7. Functionality at 3 months as assessed by the ODI

    Functionality assessed by the ODI

    Measured: 3 months post-intervention

  8. Functionality at 6 months as assessed by the ODI

    Functionality assessed by the ODI

    Measured: 6 months post-intervention

  9. Quality of life at 1 week as assessed by the EuroQol Quality of Life Questionnaire (EQ-5D-5L)

    Quality of life assessed by the EQ-5D-5L

    Measured: 1 week post-intervention

  10. Quality of life at 1 month as assessed by the EQ-5D-5L

    Quality of life assessed by the EQ-5D-5L

    Measured: 1 month post-intervention

  11. Quality of life at 3 months as assessed by the EQ-5D-5L

    Quality of life assessed by the EQ-5D-5L

    Measured: 3 months post-intervention

  12. Quality of life at 6 months as assessed by the EQ-5D-5L

    Quality of life assessed by the EQ-5D-5L

    Measured: 6 months post-intervention

  13. Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS)

    Emotional distress assessed by HADS

    Measured: 1 week post-intervention

  14. Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS)

    Emotional distress assessed by HADS

    Measured: 1 month post-intervention

  15. Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS)

    Emotional distress assessed by HADS

    Measured: 3 months post-intervention

  16. Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS)

    Emotional distress assessed by HADS

    Measured: 6 months post-intervention

  17. Optimism at 1 week as assessed by the Life Orientation Test (LOT)

    Optimism assessed by LOT

    Measured: 1 week post-intervention

  18. Optimism at 1 month as assessed by LOT

    Optimism assessed by LOT

    Measured: 1 month post-intervention

  19. Optimism at 3 months as assessed by LOT

    Optimism assessed by LOT

    Measured: 3 months post-intervention

  20. Optimism at 6 months as assessed by LOT

    Optimism assessed by LOT

    Measured: 6 months post-intervention

  21. Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS)

    Pain catastrophizing assessed by PCS

    Measured: 1 week post-intervention

  22. Pain catastrophizing at 1 month as assessed by PCS

    Pain catastrophizing assessed by PCS

    Measured: 1 month post-intervention

  23. Pain catastrophizing at 3 months as assessed by PCS

    Pain catastrophizing assessed by PCS

    Measured: 3 months post-intervention

  24. Pain catastrophizing at 6 months as assessed by PCS

    Pain catastrophizing assessed by PCS

    Measured: 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2021
  2. Study start16 May 2022
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04879394
Sponsor's protocol ID
2CA2019
Status last verified
May 2022
First submitted
4 May 2021
Last updated
25 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis in people with Low Back Pain, run by University of Minho at 1 site in Portugal.

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 1 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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 Portugal. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrícia R Pinto, PhD (00351253604926, patipinto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS) (time frame: 1 week post-intervention). The study lists 4 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 NCT04879394.

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 25 May 2022.

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