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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Exercise; Exercise Therapy
• Intervention / Treatment: Other: Personalized physical back training program; Other: Non-personalized physical back training program

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized physical back training program; 4-week personalized physical back training program	Other: 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.
Active Comparator: Non-personalized physical back training program; 4-week non-personalized physical back training program	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Logistical and operational feasibility: Response time	Response time (in days).	Baseline
Logistical and operational feasibility: Recruitment capability	Ratio of invited individuals to included participants.	Baseline
Logistical and operational feasibility: Sample characteristics	Analyze sample characteristics (e.g., gender, age) using descriptive statistics.	Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Access)	Qualitatively evaluate the access of study personnel to necessary documents and the database through interviews.	Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Questionnaire)	Qualitatively evaluate the usability of the questionnaire through interviews.	Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Clinical Assessment)	Qualitatively evaluate the usability of the clinical assessment through interviews.	Baseline to 4 weeks
Logistical and operational feasibility: Acceptability and suitability of the intervention and study procedures	Qualitatively assess the acceptability and suitability of the intervention and study procedures through interviews.	Baseline to 4 weeks
Logistical and operational feasibility: Resource management	Qualitatively evaluate the time and personnel required for conducting the study through interviews.	Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-rated physical functioning (PSFS)	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).	Baseline to 4 weeks
Self-rated physical functioning (RMDQ)	Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability).	Baseline to 4 weeks
Health-related quality of life (EQ-VAS)	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).	Baseline to 4 weeks
Health-related quality of life (EQ-5D-5L)	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).	Baseline to 4 weeks
Pain intensity (NRS)	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.	Baseline to 4 weeks
Intervention-related (serious) adverse events	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).	During the 4 week intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain frequency	Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days.	Baseline to 4 weeks
Pain duration	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.	Baseline to 4 weeks
Pain interference (PEG)	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.	Baseline to 4 weeks
Pain extent	Change in pain extent. Percentages of the body with NSLBP, with 0%=minimum	Baseline to 4 weeks
Performance-based physical functioning (pressure pain threshold)	Change in pressure pain threshold. kPA, with 0=minimum	Baseline to 4 weeks
Performance-based physical functioning (range of motion)	Change in range of motion. Degrees, with 0=minimum	Baseline to 4 weeks
Performance-based physical functioning (strength)	Change in strength. Nm, with 0=minimum	Baseline to 4 weeks
Performance-based physical functioning (neurodynamics)	Change in neurodynamics. Positive, negative.	Baseline to 4 weeks
Performance-based physical functioning (movement control)	Change in movement control. Positive, negative.	Baseline to 4 weeks
NSLBP-related work productivity loss	Change in Work Productivity and Activity Impairment Questionnaire (WPAI). Percentages, with 0%=no work productivity loss.	Baseline to 4 weeks
Participant satisfaction	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).	Baseline to 4 weeks

Collaborators and Investigators

• Sponsor: Universität Luzern
• Collaborators: Luzerner Kantonsspital
• Investigators: Principal Investigator: Claudio Perret, Prof., University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft, Frohburgstrasse 3, 6002 Luzern

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Low Back Pain; Physical Functioning
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2024-01284; 63674 (Other Grant/Funding Number: Stiftung Universität Luzern)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators plan to make encrypted individual participant data (IPD) available through a repository and/or via publications, such as supplementary materials
• IPD Sharing Time Frame: Data will be available from the completion of the study for at least 10 years.
• IPD Sharing Access Criteria: Access to the data will be granted according to the repository and/or publisher's criteria.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No