Exercise, Exercise Therapy, Low Back Pain
Conditions
Keywords
Exercise, Low Back Pain, Physical Functioning
Brief summary
The aim of our clinical trial (2024-01285) is to determine how an individualized physical back training program affects physical functioning and back pain. The results will help identify the most effective treatments for low back pain. This feasibility study (2024-01284) aims to conduct a test run of the clinical trial. The main questions are: * Do all procedures run smoothly? * Does the back training program improve physical functioning? * Does the back training program reduce back pain? Participants will: * Follow a back training program for 4 weeks. * Attend group exercise sessions (30 minutes per week) * Perform exercises at home (3x10 minutes per week). * Fill out a daily questionnaire on pain and exercise adherence.
Interventions
OTHERPersonalized physical back training program
The study intervention is a 4-week personalized physical back training program. The study intervention consists of six 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.
OTHERNon-personalized physical back training program
The control intervention is a 4-week non-personalized physical back training program. The control intervention consists of six 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.
Sponsors
Luzerner Kantonsspital
Universität Luzern
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
Individuals who * have access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers), * report NSLBP for at least 6 weeks (e.g., no upper limit of pain duration), * report activity limiting NSLBP (i.e., at least one activity with a PSFS Score of ≤ 5/10 on a scale from 0 = unable to perform due to NSLBP to 10 = able to perform at the same level as before NSLBP), * identify NSLBP as their primary musculoskeletal complaint, * are between 18 and 65 years of age, * understand the German language, * are willing to participate in the study (i.e., adhere to a 4-week intervention), * and provide written informed consent.
Exclusion criteria
Individuals who … * have been diagnosed with specific LBP (e.g., fractures, carcinoma, anomalies, nerve root affection with neurological signs such as sensitivity or reflex loss, muscle weakness, or radicular pain below the knee), * report red flags associated with any serious pathology or specific LBP (e.g., major trauma of the back, unintended weight loss, saddle anaesthesia, changes in bowel or bladder function associated with LBP, progressive lower extremity neurologic deficits, fever), * are less than 12 months post-surgery following any surgery on the lower back, * are on a waiting list for any surgery on the lower back, * are pregnant or have given birth within the last 12 months, * are planning to become pregnant in the next 12 months, * have diagnosed peripheral and/or central neurological disease, * have diagnosed psychological and/or psychiatric condition, * have diagnosed chronic toxic substances abuse (i.e., drugs, alcohol), * take specific medication (i.e., neuroleptics, sedatives, anti-epileptics, antidepressants), * are not allowed to exercise during the intervention period (e.g., on medical advice, due to a health-related condition), * or are expecting to be absent more than 2 weeks during the training intervention period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Logistical and operational feasibility: Response time | Baseline | Response time (in days). |
| Logistical and operational feasibility: Resource management | Baseline to 4 weeks | Qualitatively evaluate the time and personnel required for conducting the study through interviews. |
| Logistical and operational feasibility: Acceptability and suitability of the intervention and study procedures | Baseline to 4 weeks | Qualitatively assess the acceptability and suitability of the intervention and study procedures through interviews. |
| Logistical and operational feasibility: Data collection procedures (Clinical Assessment) | Baseline to 4 weeks | Qualitatively evaluate the usability of the clinical assessment through interviews. |
| Logistical and operational feasibility: Data collection procedures (Questionnaire) | Baseline to 4 weeks | Qualitatively evaluate the usability of the questionnaire through interviews. |
| Logistical and operational feasibility: Data collection procedures (Access) | Baseline to 4 weeks | Qualitatively evaluate the access of study personnel to necessary documents and the database through interviews. |
| Logistical and operational feasibility: Sample characteristics | Baseline to 4 weeks | Analyze sample characteristics (e.g., gender, age) using descriptive statistics. |
| Logistical and operational feasibility: Recruitment capability | Baseline | Ratio of invited individuals to included participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-rated physical functioning (RMDQ) | Baseline to 4 weeks | Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability). |
| Self-rated physical functioning (PSFS) | Baseline to 4 weeks | Change in Patient-specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 10 (able to perform at the same level as before NSLBP). |
| Health-related quality of life (EQ-VAS) | Baseline to 4 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 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 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. |
| Intervention-related (serious) adverse events | During the 4 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 ClinO, Art. 63, Switzerland). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain extent | Baseline to 4 weeks | Change in pain extent. Percentages of the body with NSLBP, with 0%=minimum |
| Pain interference (PEG) | Baseline to 4 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. |
| Pain duration | Baseline to 4 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. |
| Performance-based physical functioning (movement control) | Baseline to 4 weeks | Change in movement control. Positive, negative. |
| Performance-based physical functioning (neurodynamics) | Baseline to 4 weeks | Change in neurodynamics. Positive, negative. |
| Performance-based physical functioning (strength) | Baseline to 4 weeks | Change in strength. Nm, with 0=minimum |
| NSLBP-related work productivity loss | Baseline to 4 weeks | Change in Work Productivity and Activity Impairment Questionnaire (WPAI). Percentages, with 0%=no work productivity loss. |
| Participant satisfaction | Baseline to 4 weeks | Change in 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). 5-point Likert scale (strongly agree, agree, uncertain, disagree, strongly disagree). |
| Performance-based physical functioning (range of motion) | Baseline to 4 weeks | Change in range of motion. Degrees, with 0=minimum |
| Pain frequency | Baseline to 4 weeks | Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days. |
| Performance-based physical functioning (pressure pain threshold) | Baseline to 4 weeks | Change in pressure pain threshold. kPA, with 0=minimum |
Countries
Switzerland
Outcome results
None listed