Efficacy of ACT in Patients Scheduled for Lumbar Spine Surgery — SPINE-ACT  

Randomized Controlled Trial Clinical Trial

Official title: Efficacy of Acceptance and Commitment Therapy in Patients Scheduled for Lumbar Spine Surgery (SPINE-ACT Project)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Randomized Controlled Trial

• NCT number: NCT05634122
• Study type: Interventional
• Source: Parc de Salut Mar
• Contact: Juan Ramón Castaño-Asins, MD
• Phone: +34932483000
• Email: jrcastano@psmar.cat
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2021
• Completion date: December 31, 2024