Efficacy of ACT in Patients Scheduled for Lumbar Spine Surgery

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.

Conditions

• Randomized Controlled Trial

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy (ACT)

Group treatment protocol of 8 weeks of 90 minutes sessions Session 1: Presentation of the general ACT therapy concept. Session 2: Value analysis I. Session 3: Value analysis II. Session 4: Value analysis third Session 5: Values and feelings. Session 6: Drink one direction. Session 7: Dare and change. Session 8: Ready to act with ACT. Treatment as usual (TAU) Standard pharmacological treatment for patients with chronic pain.

BEHAVIORAL

Treatment as Usual (TAU)

Standard pharmacological treatment for patients with chronic pain

Sponsors & Collaborators

• Parc de Salut Mar

  lead OTHER

Principal Investigators

• Antonio Montes-Pérez, PhD · Parc Salut Mar

• Víctor Pérez-Solà, PhD · Parc Salut Mar

• Luis Miguel Martín-López, PhD · Parc Salut Mar

• Alejandro Del Arco-Churruca, PhD · Parc Salut Mar

• Jesús Lafuente Baraza, PhD · Parc Salut Mar

• Juan V. Luciano, PhD · Parc Sanitari Sant Joan de Déu

• Juan Ramón Castaño-Asins, MD · Parc Salut Mar

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-26

Primary Completion

2023-12-31

Completion

2024-12-31

Countries

• Spain

Study Locations