Exercise Therapy, Low Back Pain
Conditions
Keywords
Physical Functioning, Exercise
Brief summary
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.
Interventions
OTHERPersonalized back exercises
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).
OTHERNon-personalized back exercises
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).
Sponsors
Claudio Perret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers) * NSLBP for at least 6 weeks * Activity limiting NSLBP (at least one activity with a PSFS Score of ≤ 50/100 on a scale from 0 = unable to perform due to NSLBP to 100 = able to perform at the same level as before NSLBP) * Age between 18 and 65 years * Understand the German language * Willing to participate in the study * Written informed consent
Exclusion criteria
* Specific LBP * Red flags associated with any serious pathology or specific LBP, * Being on a waiting list for or less than 12 months post any surgery of the lower back * Pregnancy or given birth within the last 12 months * Diagnosed central neurological disease * Not allowed to exercise * Participant in the feasibility study * Expecting to be absent for more than 2 weeks during the intervention period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-rated physical functioning | Baseline to 12 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-rated physical functioning (RMDQ) | Baseline to 4, 8, 12, and 24 weeks | Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability). |
| Self-rated physical functioning | Baseline to 4, 8, and 24 weeks | 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) |
| Health-related quality of life (EQ-VAS) | Baseline to 4, 8, 12, and 24 weeks | 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). |
| Health-related quality of life (EQ-5D-5L) | Baseline to 4, 8, 12, and 24 weeks | 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). |
| Pain intensity (NRS) | Baseline to 4, 8, 12, and 24 weeks | 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. |
| Safety outcome | During the 12 week intervention period | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain interference (PEG) | Baseline to 4, 8, 12, and 24 weeks | 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. |
| NSLBP-related work productivity loss | Baseline to 4, 8, 12, and 24 weeks | Change in Work Productivity and Activity Impairment Questionnaire (WPAI). Percentages, with 0%=no work productivity loss. |
| Participant satisfaction | At 4, 8, 12, and 24 weeks | 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). |
| Pain duration | Baseline to 4, 8, 12, and 24 weeks | 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. |
| Pain frequency | Baseline to 4, 8, 12, and 24 weeks | Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days. |
Countries
Switzerland
Contacts
Primary ContactClaudio Perret, PhD
Backup ContactAndrea M Aegerter, PhD
Outcome results
None listed