Personalized Physical Back Training Program to Improve Physical Functioning in People with Non-specific Low Back Pain: a Feasibility Study (LIFDI)

Universität Luzern

Status: Completed

Conditions: Exercise Therapy; Exercise; Low Back Pain

Treatments: Other: Personalized physical back training program; Other: Non-personalized physical back training program

Study type: Interventional

Funder types: Other

Identifiers

NCT06540911

2024-01284

63674 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups

Personalized physical back training program

Experimental group

Description:

4-week personalized physical back training program

Treatment:

Other: Personalized physical back training program

Non-personalized physical back training program

Active Comparator group

Description:

4-week non-personalized physical back training program

Treatment:

Other: Non-personalized physical back training program