Clinical trial NCT06540911: Personalized Physical Back Training Program to Improve Physical Functioning in People with Non-specific Low Back Pain: a Feasibility Study
Official title: Personalized Physical Back Training Program to Improve Physical Functioning in People with Non-specific Low Back Pain: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Exercise
Low Back Pain
Keywords: Exercise
Low Back Pain
Physical Functioning
Lead sponsor: Universität Luzern
Sponsor class: OTHER
Collaborators: name: Luzerner Kantonsspital
First posted: 2024-08-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Logistical and operational feasibility: Response time
timeFrame: Baseline
measure: Logistical and operational feasibility: Recruitment capability
timeFrame: Baseline
measure: Logistical and operational feasibility: Sample characteristics
timeFrame: Baseline to 4 weeks
measure: Logistical and operational feasibility: Data collection procedures (Access)
timeFrame: Baseline to 4 weeks
measure: Logistical and operational feasibility: Data collection procedures (Questionnaire)
timeFrame: Baseline to 4 weeks
measure: Logistical and operational feasibility: Data collection procedures (Clinical Assessment)
timeFrame: Baseline to 4 weeks
measure: Logistical and operational feasibility: Acceptability and suitability of the intervention and study procedures
timeFrame: Baseline to 4 weeks
measure: Logistical and operational feasibility: Resource management
timeFrame: Baseline to 4 weeks
Secondary outcomes:
measure: Self-rated physical functioning (PSFS)
timeFrame: Baseline to 4 weeks
measure: Self-rated physical functioning (RMDQ)
timeFrame: Baseline to 4 weeks
measure: Health-related quality of life (EQ-VAS)
timeFrame: Baseline to 4 weeks
measure: Health-related quality of life (EQ-5D-5L)
timeFrame: Baseline to 4 weeks
measure: Pain intensity (NRS)
timeFrame: Baseline to 4 weeks
measure: Intervention-related (serious) adverse events
timeFrame: During the 4 week intervention period
Other outcomes:
measure: Pain frequency
timeFrame: Baseline to 4 weeks
measure: Pain duration
timeFrame: Baseline to 4 weeks
measure: Pain interference (PEG)
timeFrame: Baseline to 4 weeks
measure: Pain extent
timeFrame: Baseline to 4 weeks
measure: Performance-based physical functioning (pressure pain threshold)
timeFrame: Baseline to 4 weeks
measure: Performance-based physical functioning (range of motion)
timeFrame: Baseline to 4 weeks
measure: Performance-based physical functioning (strength)
timeFrame: Baseline to 4 weeks
measure: Performance-based physical functioning (neurodynamics)
timeFrame: Baseline to 4 weeks
measure: Performance-based physical functioning (movement control)
timeFrame: Baseline to 4 weeks
measure: NSLBP-related work productivity loss
timeFrame: Baseline to 4 weeks
measure: Participant satisfaction
timeFrame: Baseline to 4 weeks
Locations:
city: Luzern
country: Switzerland
facility: University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft
Study officials:
affiliation: University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft, Frohburgstrasse 3, 6002 Luzern
name: Claudio Perret, Prof.
role: PRINCIPAL_INVESTIGATOR
References: