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| ID | Type | Description | Link |
|---|---|---|---|
| 63674 | Other Grant/Funding Number | Stiftung Universität Luzern |
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Personalized medicine and individualized therapeutic approaches are prominent in current research. But are these approaches also effective for treating non-specific low back pain (NSLBP)? NSLBP is one of the most common musculoskeletal issues, which can impair physical well-being, reduce the quality of life, and limit physical functioning. Additionally, it contributes to substantial direct and indirect healthcare costs, such as frequent doctor visits and work absences. Despite NSLBP being a significant burden for both individuals and society, effective alleviation methods remain unclear. The investigators' research project therefore aims to investigate whether personalized therapy, specifically a personalized physical back training program, can effectively address NSLBP. Within the context of NSLBP, the investigators' specific aim is to improve physical functioning as this outcome is considered relevant from all perspectives, including those of patients, clinical professionals, researchers, and guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized back exercises | Experimental | The study intervention is a 12-week personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are selected through a clinical reasoning process, i.e., they are tailored and problem-oriented, based on the results of a clinical assessment. |
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| Non-personalized back exercises | Active Comparator | The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are not selected through a clinical reasoning process, i.e., they are neither tailored nor problem-oriented nor based on the results of a clinical assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized back exercises | Other | The study intervention is a 12-week personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are selected through a clinical reasoning process, i.e., they are tailored and problem-oriented, based on the results of a clinical assessment. An initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups). |
| Measure | Description | Time Frame |
|---|---|---|
| Self-rated physical functioning | Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP) | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-rated physical functioning | Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP) | Baseline to 4, 8, and 24 weeks |
| Self-rated physical functioning (RMDQ) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain frequency | Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days. | Baseline to 4, 8, 12, and 24 weeks |
| Pain duration | Change in pain duration (e.g., average duration of an episode of NSLBP within the last 7 days). In minutes, hours, or days, with 0 = minimum. Recall period: 7 days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudio Perret, PhD | Contact | +41419396650 | claudio.perret@unilu.ch | |
| Andrea M Aegerter, PhD | Contact | +41412295739 | andrea.aegerter@unilu.ch |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Perret, PhD | University of Lucerne, University Research Centre Health and Society | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre Health and Society | Recruiting | Lucerne | Canton of Lucerne | 6002 | Switzerland |
It is anticipated that the investigators will make encrypted individual participant data (IPD) available via a data repository and, additionally, upon reasonable request to the Principal Investigator. In both cases, only data from participants who have provided informed consent for data sharing will be made available.
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It is anticipated that the data will be made available as soon as possible after the completion of the study and will remain accessible for at least 10 years.
Access to the data will be granted in accordance with the criteria of the repository and/or publisher.
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Non-personalized back exercises | Other | The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are not selected through a clinical reasoning process, i.e., they are neither tailored nor problem-oriented nor based on the results of a clinical assessment. An initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups). |
|
Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability). |
| Baseline to 4, 8, 12, and 24 weeks |
| Health-related quality of life (EQ-VAS) | Change in EQ Visual Analogue Scale (EQ-VAS). Range from 0 (lowest health-related quality of life) to 100 (highest health-related quality of life). | Baseline to 4, 8, 12, and 24 weeks |
| Health-related quality of life (EQ-5D-5L) | Change in 5-Level EuroQoL5D version (EQ-5D-5L). Range from 0 (lowest health-related quality of life) to 1 (highest health-related quality of life). | Baseline to 4, 8, 12, and 24 weeks |
| Pain intensity (NRS) | Change in pain intensity (11-point Numeric Rating Scale, NRS). Range from 0 (no pain) to 10 (pain as bad as you can imagine). Recall period: 7 days. | Baseline to 4, 8, 12, and 24 weeks |
| Safety outcome | Number of serious adverse events (SAE) and adverse events (AE) that are deemed possibly, probably, or definitely related to the intervention (according to our protocol and ClinO, Art. 63, Switzerland). | During the 12 week intervention period |
| Baseline to 4, 8, 12, and 24 weeks |
| Pain interference (PEG) | Change in Pain, Enjoyment, and General Activity (PEG) 3-Item Scale. Range from 0 (no pain; does not interfere) to 10 (pain as bad as you can imagine; completely interferes). Recall period: 7 days. | Baseline to 4, 8, 12, and 24 weeks |
| NSLBP-related work productivity loss | Change in Work Productivity and Activity Impairment Questionnaire (WPAI). Percentages, with 0%=no work productivity loss. | Baseline to 4, 8, 12, and 24 weeks |
| Participant satisfaction | Participant satisfaction (e.g., 1. I am satisfied with the training program I received. 2. I am satisfied with the result of the training program). 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). | At 4, 8, 12, and 24 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |