After Lumbar Spine Surgery, Chronic Low Back Pain, Failed Back Surgery Syndrome (FBSS)
Conditions
Keywords
Cognitive Functional Therapy, Spinal Surgery, Low-intensity light therapy, Placebo, Pain management, back pain, chronic pain, low back pain, Sham
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALCFT
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.
DEVICESham Detuned Photobiomodulation
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.
Sponsors
Centro Universitário Augusto Motta
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This study will be a randomized, sham-controlled trial with concealed allocation, participant and assessor blinding, and analysis conducted according to the intention-to-treat principle. Patients will be evaluated at baseline, 12 weeks and 24 weeks after randomization. Immediately post intervention, participants will be asked if they received the sham or active intervention, as a means to confirm the blinding. The possible answers will be: 'sham', 'active treatment' or 'I don't know'. The James Blinding Index (JBI) and Cohen's kappa (k) will be used to statistically assess the success of blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years * Chronic low back pain ≥12 weeks * History of lumbar surgery ≥3 months * Pain intensity ≥3 (NPRS) * ODI ≥14%
Exclusion criteria
* Serious spinal pathology * Neurological disorders * Radiculopathy * Pregnancy * Unstable cardiac conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability on ODI | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability on ODI | 24 weeks | 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. |
| Anxiety | 12 weeks, 24 weeks | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome |
| Depression | 12 weeks, 24 weeks | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome. |
| Catastrophization | 12 weeks, 24 weeks | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome. |
| Fear of movement | 12 weeks, 24 weeks | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome. |
| Social isolation | 12 weeks, 24 weeks | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome. |
| Stress | 12 weeks, 24 weeks | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome. |
| Sleep Disturbance | 12 weeks, 24 weeks | The outcome related to sleep disturbance will be extracted from this inventory (Eriksen, Ihlebæk, \& Ursin, 1999). This variable will be assessed using the question: "Have you had problems with sleep in the past month?" Based on the Subjective Health Complaints Inventory, response options range from "none" = 0, "a little" = 1, "some" = 2, and "severe" = 3. |
| Pain Intensity (NPRS) | 12 weeks, 24 weeks | 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). |
Contacts
CONTACTThátira Camilo, PhD student
Outcome results
None listed