Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery

N/ANot Yet RecruitingNCT07576062

Centro Universitário Augusto Motta90 enrolled

Overview

Chronic low back pain after spinal surgery is a complex and disabling condition influenced by biopsychosocial factors. Cognitive Functional Therapy (CFT) is a promising intervention targeting these multidimensional aspects. This randomized, sham-controlled trial aims to compare the efficacy of CFT versus a sham intervention (detuned photobiomodulation) in participants with chronic low back pain after spinal surgery.

Cognitive Functional Therapy (CFT) is a multidimensional intervention based on the biopsychosocial nature of chronic pain. The intervention comprises three main components: (1) making sense of pain, (2) exposure with control, and (3) lifestyle changes. The trial will be conducted at a private outpatient clinic located in Cachoeiro de Itapemirim, Espírito Santo, Brazil. A total of 90 participants of both sexes with chronic low back pain after spinal surgery will be randomly allocated to one of two intervention groups: (I) the CFT group (n = 45) and (II) the sham group (n = 45). Participants will attend one session per week for a period of 12 weeks. The primary outcome will be disability, measured using the Oswestry Disability Index (ODI; 0-100).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Low Back Pain After Lumbar Spine Surgery

Interventions

CFTBEHAVIORAL

Participants will receive up to eight sessions of Cognitive Functional Therapy (CFT), each lasting 50 minutes, delivered once per week over a maximum of 12 weeks; the first session will last 60 minutes. Weekly reminders will be provided to enhance adherence. All participants will receive an educational booklet addressing chronic pain, maladaptive beliefs, and unhelpful pain-related behaviors. The intervention includes individualized strategies aimed at improving pain understanding, reducing protective behaviors, promoting functional movement, and supporting lifestyle changes. The program also incorporates strategies for autonomous management of symptom exacerbations. The fidelity of the CFT intervention will be monitored through recorded sessions throughout the clinical trial. Recordings will be made for every seven participants allocated to the CFT group. Three researchers with expertise in the CFT will watch the recorded videos and provide feedback to the treating physiotherapist.

Sham Detuned PhotobiomodulationDEVICE

A detuned photobiomodulation device (infrared DMC 904 nm, non-visible beam) will be used, delivering no therapeutic dose (0 J). Applications will be performed at standardized points in the lumbar region, including central points over the spinous processes and bilateral paravertebral regions, without active energy delivery. Each session will last 27 minutes, totaling eight sessions per participant. Additionally, participants will receive at least 15 minutes of neutral talking, in which maladaptive beliefs will not be challenged. The therapist will maintain an empathetic and engaging posture while encouraging discussion of neutral topics (e.g., hobbies, sports, current events), without providing advice or problem-solving. Pain-related or emotional discussions will be gently redirected. Weekly reminders will be provided to enhance adherence. All participants will receive an educational booklet addressing chronic pain, maladaptive beliefs, and unhelpful pain-related behaviors.

Outcomes

Primary Outcomes

Disability on ODI

Disability due to low back pain (LBP), assessed using the Oswestry Disability Index (ODI; 0-100) at post-treatment (12 weeks), will be the primary outcome measure. The ODI was originally developed by Fairbank et al. (1980) and consists of 10 items, each with six response options. The version adapted and validated for Brazilian Portuguese was proposed by Vigatto et al. (2007). The total score will be calculated by summing the items, with a maximum score of 50 points, which is subsequently converted into a percentage (0 to 100), with higher scores indicating greater functional disability.

Time frame: 12 weeks

Secondary Outcomes

Pain Intensity (NPRS)

The Numeric Pain Rating Scale (NPRS), which will be administered verbally in this study in the form of an interview at the time of assessment, is a unidimensional measure that is easy to apply across different cultures and languages, and has been validated for assessing pain intensity in adults. It consists of 11 integer points ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst imaginable pain" (Childs, Piva, \& Fritz, 2005). Lower NPRS scores indicate lower pain intensity, which can be qualitatively classified as mild (1-3 points), moderate (4-6 points), and severe (7-10 points).