Personalized Physical Back Training Program to Improve Physical Functioning in People with Non-specific Low Back Pain: a Feasibility Study
- Conditions
- ExerciseExercise TherapyLow Back Pain
- Interventions
- Other: Non-personalized physical back training programOther: Personalized physical back training program
- Registration Number
- NCT06540911
- Lead Sponsor
- Universität Luzern
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-personalized physical back training program Non-personalized physical back training program 4-week non-personalized physical back training program Personalized physical back training program Personalized physical back training program 4-week personalized physical back training program
- Primary Outcome Measures
Name Time Method 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 (Clinical Assessment) Baseline to 4 weeks Qualitatively evaluate the usability of the clinical assessment through interviews.
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: 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: 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: Sample characteristics Baseline to 4 weeks Analyze sample characteristics (e.g., gender, age) using descriptive statistics.
Logistical and operational feasibility: Response time Baseline Response time (in days).
Logistical and operational feasibility: Recruitment capability Baseline Ratio of invited individuals to included participants.
- Secondary Outcome Measures
Name Time Method 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.
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).
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).
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).
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).
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).
Trial Locations
- Locations (1)
University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft
🇨🇭Luzern, Switzerland