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NCT Number: NCT07576062

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

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.

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Key information

Conditions

Chronic Low Back Pain After Lumbar Spine Surgery Agnosia Back Pain Chronic Pain Failed Back Surgery Syndrome Failed Back Surgery Syndrome (FBSS) Low Back Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CFT

Behavioral

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 Photobiomodulation

Device

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.

Primary outcomes

  1. Disability on ODI

    Time frame: 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 outcomes

  1. Pain Intensity (NPRS)

    Time frame: 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).

  2. Sleep Disturbance

    Time frame: 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.

  3. Disability on ODI

    Time frame: 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.

  4. Anxiety

    Time frame: 12 weeks, 24 weeks

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome

  5. Depression

    Time frame: 12 weeks, 24 weeks

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.

  6. Catastrophization

    Time frame: 12 weeks, 24 weeks

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.

  7. Fear of movement

    Time frame: 12 weeks, 24 weeks

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.

  8. Social isolation

    Time frame: 12 weeks, 24 weeks

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.

  9. Stress

    Time frame: 12 weeks, 24 weeks

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Thátira Camilo, PhD student

CONTACT

[email protected]

+5528999696872

Sponsors and collaborators

Lead sponsor

Centro Universitário Augusto Motta

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery: A Randomized, Sham-Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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