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

NCT ID: NCT06540911

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-02
• Study Completion Date: 2024-12-19

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.

Conditions

Exercise Therapy; Exercise; Low Back Pain

Keywords

Exercise; Low Back Pain; Physical Functioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Personalized physical back training program

4-week personalized physical back training program

Group Type: EXPERIMENTAL

Personalized physical back training program

Intervention Type: OTHER

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.

Non-personalized physical back training program

4-week non-personalized physical back training program

Group Type: ACTIVE_COMPARATOR

Non-personalized physical back training program

Intervention Type: OTHER

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.

Interventions

Personalized 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.

Intervention Type: OTHER

Non-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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luzerner Kantonsspital

OTHER

Sponsor Role: collaborator

Universität Luzern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Perret, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft, Frohburgstrasse 3, 6002 Luzern

Locations

University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft

Lucerne, Canton of Lucerne, Switzerland

Countries

Switzerland

Other Identifiers

63674

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-01284

Identifier Type: -

Identifier Source: org_study_id