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Trial · NCT07877454

Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy

NCT07877454, Not applicable, Not yet recruiting, University of Oulu

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy. Trials, record NCT07877454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877454

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy
NCT number
NCT07877454
Status
Not yet recruiting
Phases
Not applicable
Enrollment
461 participants, estimated
Lead sponsor
University of Oulu
Conditions
Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
Interventions
Cognitive Functional Therapy (CFT), Usual Care
First posted
2026-10-16
Last updated
2026-10-16

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAverage low back pain-related disability over 12-month follow-upBaseline to 52 weeks
Low back pain-related disability will be assessed using an area under the curve (AUC) approach based on the 24-item Roland-Morris Disability Questionnaire (RMDQ) score, measured at baseline, at 2 weeks, at 4 weeks, and subsequently every 4 weeks through 52 weeks.
SecondaryLow back pain-related disabilityBaseline and at weeks 2, 4, 12, 24, 52, and 156.
Low back pain-related disability will be assessed using the 24-item Roland-Morris Disability Questionnaire (RMDQ). The total score ranges from 0 to 24, with higher scores indicating greater disability (worse outcome) and lower scores indicating less disability.
SecondaryPain intensityBaseline and at weeks 2, 4, 12, 24, 52, and 156.Measured using the 0-10 numerical rating scale (0=no low back pain, 10=worst possible low back pain), assessing average low back pain intensity during the preceding 7 days.
SecondaryAverage pain intensity over 12-month follow-upBaseline to 52 weeks
Average pain intensity will be assessed using an area under the curve (AUC) approach based on the 0-10 Numerical Rating Scale (NRS) score, assessing average low back pain intensity during the preceding 7 days, measured at baseline, at 2 weeks, at 4 weeks, and subsequently every 4 weeks through 52 weeks.
SecondaryRecovery (pain-free and minimal disability)At 12, 24, 52, and 156 weeks after baseline
Recovery will be assessed as a dichotomous composite outcome (recovered/not recovered). Participants will be classified as recovered if they report a pain intensity score of 0 on the 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain, and a score of less than 2 on the 24-item Roland-Morris Disability Questionnaire (RMDQ), which ranges from 0 to 24 with higher scores indicating greater disability. The outcome will be reported as the proportion of participants classified as recovered, with higher proportions indicating better outcomes.
SecondaryPain catastrophizingAt baseline and 2, 6, 12, 24, 52, and 156 weeks after baseline
Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale (PCS). The questionnaire consists of 13 items rated on a 5-point Likert scale, yielding a total score from 0 to 52, with higher scores indicating greater pain catastrophizing.
SecondaryPain self-efficacyAt baseline and 2, 6, 12, 24, 52, and 156 weeks after baseline.
Pain self-efficacy will be assessed using the 10-item Pain Self-Efficacy Questionnaire (PSEQ). Items are rated on a 7-point scale, yielding a total score from 0 to 60, with higher scores indicating greater pain self-efficacy.
SecondaryFear-avoidance beliefsAt baseline and 2, 6, 12, 24, 52, and 156 weeks after baseline
Fear-avoidance beliefs will be assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ), a validated 16-item self-report questionnaire that measures beliefs about how physical activity and work may affect low back pain. Total scores range from 0 to 96, with higher scores indicating greater fear-avoidance beliefs (worse outcome).
SecondaryPatient-specific functional limitationAt baseline and 6, 12, 24, 52, and 156 weeks after baseline.
Patient-specific functional limitation will be assessed using the Patient-Specific Functional Scale (PSFS), a validated self-report measure in which participants identify up to three activities they have difficulty performing because of their low back pain and rate their ability to perform each activity on an 11-point numeric scale (0-10). Higher scores indicate better functional ability.
SecondaryPatient satisfaction with care12 weeks after baseline.
Patient satisfaction with care will be assessed using a single-item 7-point Likert scale. Scores range from 1 (very dissatisfied) to 7 (very satisfied), with higher scores indicating greater satisfaction with care (better outcome)

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07877454

GET https://conductscience.org/api/trials/v1/NCT07877454/registered