Clinical trial NCT06105281: Nurse Specialist Intervention Promoting Altered Coping and Treatment for Chronic Pain
Official title: What Impact Does a Consultation With a Nurse Pain Specialist Have on Behaviour Towards Chronic Pain and Pain Intensity in Chronic Pain Patients?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Vitaz
First posted: 2023-10-27
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric Randomised controlled trail in the Vitaz Hospital of Sint-Niklaas. It will take place at the pain clinic where patient with chronic pain come for a treatment or infiltration against chronic pain. There will be two groups of patients, an intervention and an control arm with an equal allocation (1:1). The intervention and control arm will complete the study simultaneous. In each group will count 86 participance at the begin of the trail. This give us the possibility of 35% loss of follow up in each group, so that we can end the study with 64 participants in each group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate of the implementation of an autonomous consultation with a nurse pain specialist for chronic pain patients has an influence on the behaviour towards the chronic pain. The trail will be done with patients that has planned an infiltration in a pain centre. Furthermore the pain intensity and patent satisfaction will be investigated as second outcomes.

During the consultation there will be explained what the patient can expect from the treatment in the pain clinic. What the patient expect from the infiltration will also be surveyed, so that it can be adjusted if necessary. In the end of the consultation there will be a brief explanation of chronic pain and the physiology as well als the different factors that have an influence on it.

This study is a monocentric randomised controlled trail of 172 participants, with an equal allocation (1:1). To collect the data there will be three different questionnaires for both groups. The first is a baseline measurement. The second will take place three weeks after the infiltration and the third ten weeks after the infiltration. This is in order to see if there is an evolution in the outcomes during time.


Eligibility criteria: Inclusion criteria:

* Patients that have an appointment for a treatment
* Patients with chronic pain, so 3 months or more and of functional dysfunction because of the pain.
* Patients that are receiving a spinal treatment form the cervical, thoracic or lumbar spine.
* The patient has to understand the Dutch language.

Exclusion criteria:

* Patients with a neurostimulator, an intrathecal medication pump or patients that already has an appointment at the consultation in the pain clinic. They have an doctor- patient relationship and that can cause bias.
* People who are legally incapable (persons younger then 18 years, persons with dementia, other cognitive diseases.
* People with facial pain. Here is the necessity of quick treatments. Or they already take place in other studies.
* People who are interned or detained. There is no possibility of follow-up.
* Palliative, oncologic or in hospital patients
* Patients who need a emergency treatment, because it is mostly acute or sub acute pain.

Primary outcomes:
measure: Behavior towards chronic pain
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: Vitaz campus Sint-Niklaas
state: Oost-Vlaanderen
Study officials:
affiliation: Universiteit Antwerpen
name: Filip Haegdorens, PhD
role: PRINCIPAL_INVESTIGATOR
References: