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

December 19, 2024 updated by: Universität Luzern

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Logistical and operational feasibility: Response time
Time Frame: Baseline
Response time (in days).
Baseline
Logistical and operational feasibility: Recruitment capability
Time Frame: Baseline
Ratio of invited individuals to included participants.
Baseline
Logistical and operational feasibility: Sample characteristics
Time Frame: Baseline to 4 weeks
Analyze sample characteristics (e.g., gender, age) using descriptive statistics.
Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Access)
Time Frame: Baseline to 4 weeks
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)
Time Frame: Baseline to 4 weeks
Qualitatively evaluate the usability of the questionnaire through interviews.
Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Clinical Assessment)
Time Frame: Baseline to 4 weeks
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
Time Frame: Baseline to 4 weeks
Qualitatively assess the acceptability and suitability of the intervention and study procedures through interviews.
Baseline to 4 weeks
Logistical and operational feasibility: Resource management
Time Frame: Baseline to 4 weeks
Qualitatively evaluate the time and personnel required for conducting the study through interviews.
Baseline to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-rated physical functioning (PSFS)
Time Frame: 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).
Baseline to 4 weeks
Self-rated physical functioning (RMDQ)
Time Frame: Baseline to 4 weeks
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)
Time Frame: 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).
Baseline to 4 weeks
Health-related quality of life (EQ-5D-5L)
Time Frame: 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).
Baseline to 4 weeks
Pain intensity (NRS)
Time Frame: 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.
Baseline to 4 weeks
Intervention-related (serious) adverse events
Time Frame: 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).
During the 4 week intervention period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain frequency
Time Frame: Baseline to 4 weeks
Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days.
Baseline to 4 weeks
Pain duration
Time Frame: Baseline to 4 weeks
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)
Time Frame: Baseline to 4 weeks
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
Time Frame: Baseline to 4 weeks
Change in pain extent. Percentages of the body with NSLBP, with 0%=minimum
Baseline to 4 weeks
Performance-based physical functioning (pressure pain threshold)
Time Frame: Baseline to 4 weeks
Change in pressure pain threshold. kPA, with 0=minimum
Baseline to 4 weeks
Performance-based physical functioning (range of motion)
Time Frame: Baseline to 4 weeks
Change in range of motion. Degrees, with 0=minimum
Baseline to 4 weeks
Performance-based physical functioning (strength)
Time Frame: Baseline to 4 weeks
Change in strength. Nm, with 0=minimum
Baseline to 4 weeks
Performance-based physical functioning (neurodynamics)
Time Frame: Baseline to 4 weeks
Change in neurodynamics. Positive, negative.
Baseline to 4 weeks
Performance-based physical functioning (movement control)
Time Frame: Baseline to 4 weeks
Change in movement control. Positive, negative.
Baseline to 4 weeks
NSLBP-related work productivity loss
Time Frame: Baseline to 4 weeks
Change in Work Productivity and Activity Impairment Questionnaire (WPAI). Percentages, with 0%=no work productivity loss.
Baseline to 4 weeks
Participant satisfaction
Time Frame: Baseline to 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universität Luzern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Luzerner Kantonsspital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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