Clinical trial NCT05634122: Efficacy of ACT in Patients Scheduled for Lumbar Spine Surgery
Official title: Efficacy of Acceptance and Commitment Therapy in Patients Scheduled for Lumbar Spine Surgery (SPINE-ACT Project)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Randomized Controlled Trial
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Objectives: (1) To analyze the effectiveness of adding a group-based form of Acceptance and Commitment Therapy (ACT) to the treatment as usual (TAU) for preoperative patients diagnosed with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain at baseline and after psychological treatment. (2) To examine the effectiveness of ACT on the improvement of pain interference, pain-related and behavioral variables in degenerative lumbar pathology preoperative patients after lumbar spine surgery in comparison with TAU. (3) To measure the proximal and distal effects of ACT in preoperative patients with degenerative lumbar pathology who had the surgery after ACT program completion in comparison with proximal and distal TAU surgery effects on pain related variables.

Method: A 12-month randomized controlled trial (RCT) will be conducted at Hospital del Mar (Barcelona). Only those preoperative degenerative lumbar pathology patients with psychosocial risk factors for chronic post-surgical pain will be randomized to pre-surgical ACT group or to TAU. Evaluations will be completed before treatment (baseline), after ACT therapy (3 months), a first follow-up (6 months from baseline alias 3 months after surgery), second follow-up (9 months from baseline alias 6 months after surgery), and final follow-up (15 months from baseline alias 12 months from surgery).

Participants: 80 adult preoperative patients with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain will be randomly assigned to two arms: ACT + TAU vs TAU.

Primary outcome: Pain interference. Secondary outcomes: pain intensity, pain catastrophising, pain acceptance, pain disability, kinesiophobia, depression symptoms, anxiety symptoms, psychological flexibility, and quality of life.

Main statistical analyses: Intention-to-Treat analyses that will include all participants who undergo random allocation, using multiple imputation to replace missing values. General linear mixed-effects models will be performed using Restricted Maximum Likelihood to estimate the parameters. Calculation of between-groups effect sizes using Cohen's d and of the number-needed-to-treat.

Detailed description: The Spine-ACT project's main objective is to determine the effectiveness of adding to the standard care (TAU) of preoperative patients with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain, a group-based form of ACT. In this regard, assessing patients' results after surgery at proximal or distal improvement on pain-related variables compared with TAU surgery patients would be addressed. The Spine-ACT project will assess the usefulness of ACT therapy applied before surgery to improve pain-related variables and quality of life in preoperative degenerative lumbar pathology patients with psychosocial risk factors of developing chronic or post-surgical pain. This project will significantly expand the limited knowledge available about preoperative pain-related improvement through ACT therapy and how this psychological therapy could prevent post-surgical chronic pain. Thus, it is expected that ACT therapy can improve the various pain-related and quality-of-life variables in developing chronic pain in preoperative patients diagnosed with degenerative lumbar pathology plus psychosocial risk factors of post-surgical chronic pain.

Eligibility criteria: Inclusion Criteria:

* Age 18- 80 years
* Possess an adequate understanding of Spanish or Catalan
* Meet the diagnostic criteria for lumbar pain/degenerative lumbar pathology candidates for surgical treatment.

  * Diagnoses:

    1. Lumbar canal stenosis.
    2. Foraminal stenosis.
    3. Lumbar spondylolisthesis.
    4. Lumbar degenerative disc disease.
    5. Degenerative scoliosis.
    6. Lumbar kyphosis.
  * Procedures:

Laminectomy. Foraminoplasty. Laminectomy and posterior arthrodesis. previous arthrodesis.

* Presence of psychosocial risk factors for chronic post-surgical pain:

  * Mild-moderate anxiety/depression symptoms (HADS hospital anxiety and depression sub-scales≥11, see measurement instruments section) and/or
  * Presence of catastrophizing (PCS catastrophizing scale (0-52) ≥24, see measurement instruments section), and/or
  * Kinesiophobia base ≥27, see measurement instruments section)
* Have an internet connection on a mobile phone, tablet, computer, etc. to be able to carry out group psychological therapy online.
* Give authorization by signing an informed consent

Exclusion Criteria:

* Cognitive impairment that in the clinician's judgment prevents you from participating in therapy
* Presenting chronic pain not related to the diagnosis of low back pain that is a candidate for surgical treatment
* NOT present psychosocial risk factors for chronic post-surgical pain (see inclusion criteria: anxiety, catastrophizing, depression, kinesiophobia)
* Patients in litigation or who are pending legal claims for compensation
* Severe or decompensated psychiatric disorder (depression, schizophrenia, bipolar disorder, personality disorder) that in the clinician's judgment prevents you from participating in therapy
* Suicidal ideation
* Consumption of toxic substances in abuse/dependence, except for smoking
* Patients with a language barrier (Spanish/Catalan)
* Patients who do not authorize it voluntarily and do not want to participate

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Through study completion, an average of 2 years
measure: Pain Catastrophising Scale (PCS)
timeFrame: Through study completion, an average of 2 years
measure: Psychological Inflexibility in Pain Scale (PIPS)
timeFrame: Through study completion, an average of 2 years
measure: Tampa Kinesiophobia Scale (TSK-11SV)
timeFrame: Through study completion, an average of 2 years
measure: Chronic Pain Acceptance Questionnaire (CPAQ-20)
timeFrame: Through study completion, an average of 2 years
measure: Short Form 12 Health Survey (SF-12)
timeFrame: Through study completion, an average of 2 years
measure: Oswestry Low Back Pain Disability Scale (OLBPDQ)
timeFrame: Through study completion, an average of 2 years
Other outcomes:
measure: Socio-demographic questionnaire
timeFrame: Baseline
Locations:
city: Barcelona
country: Spain
facility: Parc Salut Mar
Study officials:
affiliation: Parc Salut Mar
name: Antonio Montes-Pérez, PhD
role: STUDY_DIRECTOR
affiliation: Parc Salut Mar
name: Víctor Pérez-Solà, PhD
role: STUDY_DIRECTOR
affiliation: Parc Salut Mar
name: Luis Miguel Martín-López, PhD
role: STUDY_CHAIR
affiliation: Parc Salut Mar
name: Alejandro Del Arco-Churruca, PhD
role: STUDY_DIRECTOR
affiliation: Parc Salut Mar
name: Jesús Lafuente Baraza, PhD
role: STUDY_CHAIR
affiliation: Parc Sanitari Sant Joan de Déu
name: Juan V. Luciano, PhD
role: STUDY_DIRECTOR
affiliation: Parc Salut Mar
name: Juan Ramón Castaño-Asins, MD
role: PRINCIPAL_INVESTIGATOR
References: