An interventional study of CFT and Sham Detuned Photobiomodulation in Chronic Low Back Pain, After Lumbar Spine Surgery and Failed Back Surgery Syndrome (FBSS), sponsored by Centro Universitário Augusto Motta. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Centro Universitário Augusto Motta · Not applicable, Interventional, and Treatment
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).
104 studies on the registry are indexed under Failed Back Surgery Syndrome; 17 are open to participants now.
This study's planned enrollment of 90 is above the median of 40 across 75 interventional studies indexed under Failed Back Surgery Syndrome.
Browse Failed Back Surgery Syndrome studies →Centro Universitário Augusto Motta is the lead sponsor of 39 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants allocated to this group will receive Cognitive Functional Therapy (CFT), a physiotherapy-led intervention targeting pain-related behaviors, beliefs, and functional limitations. The program includes individualized sessions focusing on making sense of pain, exposure with control, and lifestyle changes. Sessions will be delivered weekly over a period of up to 12 weeks. The physiotherapist--researcher has completed more than 80 hours of training, including in--person and online courses, supervisions and interactive case discussions with feedback by physical therapists with more than 10 years of clinical experience using CFT in Brazil.
Behavioral: CFT
Participants allocated to this group will receive sham photobiomodulation combined with neutral talking. The intervention is designed to control for non-specific effects such as therapist attention and interaction, without delivering an active intervention. Sessions will be conducted weekly over the study period.
Device: Sham Detuned Photobiomodulation
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.
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.
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
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).
Time frame: 12 weeks, 24 weeks
Sleep Disturbance
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.
Time frame: 12 weeks, 24 weeks
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: 24 weeks
Anxiety
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Time frame: 12 weeks, 24 weeks
Depression
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
Time frame: 12 weeks, 24 weeks
Catastrophization
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
Time frame: 12 weeks, 24 weeks
Fear of movement
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
Time frame: 12 weeks, 24 weeks
Social isolation
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
Time frame: 12 weeks, 24 weeks
Stress
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
Time frame: 12 weeks, 24 weeks
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Failed Back Surgery Syndrome →
Centro Universitário Augusto Motta