NCT05634122: SPINE-ACT

Efficacy of ACT in Patients Scheduled for Lumbar Spine Surgery

Status unknown NA Last updated 7 December 2022

What this trial tests

NA trial testing Acceptance and Commitment Therapy (ACT) in Randomized Controlled Trial in 80 participants. Status unknown.

Timeline

26 November 2021

Primary endpoint
31 December 2023

31 December 2024

Quick facts

Lead sponsor	Parc de Salut Mar
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	26 November 2021
Primary completion	31 December 2023
Estimated completion	31 December 2024
Sites	1 location across Spain

Drugs / interventions tested

• Acceptance and Commitment Therapy (ACT)
• Treatment as Usual (TAU) — full drug profile →

Conditions studied

• Randomized Controlled Trial — all drugs for Randomized Controlled Trial →

Sponsor

Parc de Salut Mar — full company profile →

Who can join

Adults 18 to 80, any sex, with Randomized Controlled Trial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of Acceptance and Commitment Therapy (ACT) for the Management of Postsurgical Pain: Study Protocol of a Randomized Controlled Trial (SPINE-ACT Study).
   Castaño-Asins JR, Sanabria-Mazo JP, Luciano JV, Barceló-Soler A, et al · · 2023 · cited 1× · PMID 37373758 · DOI 10.3390/jcm12124066
2. Effectiveness of Acceptance and Commitment Therapy (ACT) for the Management of Postsurgical Pain: A Randomized Controlled Trial (SPINE-ACT Study).
   Castaño-Asins JR, Sanabria-Mazo JP, Navarrete J, Martín-López LM, et al · · 2026 · PMID 42109189 · DOI 10.1002/ejp.70293