Trial · NCT07877454
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average low back pain-related disability over 12-month follow-up | Baseline 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. |
| Secondary | Low back pain-related disability | Baseline 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. |
| Secondary | Pain intensity | Baseline 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. |
| Secondary | Average pain intensity over 12-month follow-up | Baseline 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. |
| Secondary | Recovery (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. |
| Secondary | Pain catastrophizing | At 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. |
| Secondary | Pain self-efficacy | At 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. |
| Secondary | Fear-avoidance beliefs | At 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). |
| Secondary | Patient-specific functional limitation | At 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. |
| Secondary | Patient satisfaction with care | 12 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) |
| Secondary | Treatment adherence | At 2, 6, and 12 weeks after baseline. | Treatment adherence will be assessed as a patient-reported outcome using a single-item 11-point numeric rating scale ranging from 0 (not at all) to 10 (completely). Higher scores indicate greater adherence to the treatment recommended by the physiotherapist. |
| Secondary | Therapeutic relationship | At 2 weeks after baseline. | The therapeutic relationship will be assessed using the 10-item Consultation and Relational Empathy (CARE) Measure, a validated patient-reported questionnaire assessing empathy in the context of the therapeutic relationship during the consultation between a clinician and a patient. Total scores range from 10 to 50, with higher scores indicating a more positive perception of the consultation and greater relational empathy (better outcome). |
| Secondary | Health-related quality of life | Baseline, weeks 12, 24, 52, and 156 | Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L index score ranges from values below 0 to 1.0, with higher scores indicating better health-related quality of life (better outcome). |
| Secondary | Sick leave due to low back pain | Patient-reported: Baseline, weeks 12, 24, 40, 52, and 156. Registry data: 52 weeks before baseline to 156 weeks after baseline | Number of days of sick leave due to low back pain, assessed using patient-reported questionnaires. National registry data (Kela health insurance statistics) on sickness absence will also be collected to complement the patient-reported data and support the economic evaluation. |
| Secondary | Work disability (partial or full) | Registry data: 52 weeks before baseline to 156 weeks after baseline | Work disability status (partial or full), assessed using national registry data from the Kela health insurance statistics and the Finnish Centre for Pensions. |
| Secondary | Direct healthcare costs (including public healthcare and patient out-of-pocket expenses) | Patient-reported: Baseline, weeks 12, 24, 40, 52, and 156. Registry data: 52 weeks before baseline to 156 weeks after baseline | Direct healthcare costs, estimated from healthcare resource utilization obtained from the AvoHilmo and Hilmo registries together with patient-reported out-of-pocket healthcare expenses. These data will be used in the planned economic evaluation. |
| Secondary | Healthcare utilization related to low back pain | Patient-reported: Baseline, weeks 12, 24, 40, 52, and 156. Registry data: 52 weeks before baseline to 156 weeks after baseline | Healthcare utilization related to low back pain will be assessed using patient-reported questionnaires and national registry data (AvoHilmo and Hilmo). Healthcare utilization includes physiotherapy visits, physician visits, imaging, hospital services, and other healthcare services related to low back pain. The outcome will be reported as the total number of low back pain-related healthcare contacts during follow-up. Values range from 0 upward, with higher values indicating greater healthcare utilization. |
| Secondary | Global perceived recovery | Weeks 2, 6, 12, 24, 52, and 156 | Global perceived recovery will be assessed using a 7-point Likert scale ranging from 1 (much worse) to 7 (fully recovered), with higher scores indicating greater perceived recovery (better outcome). |
| Secondary | Adverse events | At 2, 6, 12, 24, 40, 52, and 156 weeks after baseline. | Adverse events related to the study interventions will be assessed using patient-reported questionnaires throughout the study. The outcome will be reported as the number of participants experiencing one or more adverse events and the total number and type of adverse events recorded during follow-up. |
| Secondary | Back pain knowledge and beliefs | Baseline and at weeks 2, 6, 12, 24, 52 and 156. | Back pain knowledge and beliefs will be assessed using the 20-item Back Pain Knowledge and Beliefs Survey (BacKS). Items are rated on a 5-point Likert scale, yielding a total score from 20 to 100, with higher scores indicating greater evidence-based knowledge and more positive beliefs about low back pain. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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