Exercise TherapyLIFDINCT06938568
Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain
A study testing Personalized back exercises and Non-personalized back exercises in people with Exercise Therapy and Low Back Pain, run by Claudio Perret at 1 site in Switzerland.
Trial summary
Personalized medicine and individualized therapeutic approaches are prominent in current research. But are these approaches also effective for treating non-specific low back pain (NSLBP)? NSLBP is one of the most common musculoskeletal issues, which can impair physical well-being, reduce the quality of life, and limit… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Exercise Therapy, Low Back Pain
- What is being tested?
- Personalized back exercises and Non-personalized back exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers)
- NSLBP for at least 6 weeks
- Activity limiting NSLBP (at least one activity with a PSFS Score of ≤ 50/100 on a scale from 0 = unable to perform due to NSLBP to 100 = able to perform at the same level as before NSLBP)
- Age between 18 and 65 years
- Understand the German language
- Willing to participate in the study
- Written informed consent
Who cannot join
- Specific LBP
- Red flags associated with any serious pathology or specific LBP,
- Being on a waiting list for or less than 12 months post any surgery of the lower back
- Pregnancy or given birth within the last 12 months
- Diagnosed central neurological disease
- Not allowed to exercise
- Participant in the feasibility study
- Expecting to be absent for more than 2 weeks during the intervention period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre Health and Society
Lucerne, Canton of Lucerne, 6002
Claudio Perret, PhD, +41419396650, claudio.perret@unilu.ch
Andrea M Aegerter, PhD, +41412295739, andrea.aegerter@unilu.ch
About this study
Personalized medicine and individualized therapeutic approaches are prominent in current research. But are these approaches also effective for treating non-specific low back pain (NSLBP)? NSLBP is one of the most common musculoskeletal issues, which can impair physical well-being, reduce the quality of life, and limit physical functioning. Additionally, it contributes to substantial direct and indirect healthcare costs, such as frequent doctor visits and work absences. Despite NSLBP being a significant burden for both individuals and society, effective alleviation methods remain unclear. The investigators' research project therefore aims to investigate whether personalized therapy, specifically a personalized physical back training program, can effectively address NSLBP. Within the context of NSLBP, the investigators' specific aim is to improve physical functioning as this outcome is considered relevant from all perspectives, including those of patients, clinical professionals, researchers, and guidelines.
- Conditions
- Exercise Therapy, Low Back Pain
- Being tested
- Personalized back exercises, Non-personalized back exercises
- Keywords
- Physical Functioning, Exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized back exercisesOther
The study intervention is a 12-week personalized physical back training program. It consists of six to eight 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.
An initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups).
Non-personalized back exercisesOther
The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight 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.
An initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups).
| Study group | Role | What they receive |
|---|---|---|
| Personalized back exercises | Experimental | The study intervention is a 12-week personalized physical back training program. It consists of six to eight 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. Receives: Other: Personalized back exercises |
| Non-personalized back exercises | Active comparator | The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight 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. Receives: Other: Non-personalized back exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-rated physical functioning
Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)
Measured: Baseline to 12 weeks
Secondary outcomes (6)
Self-rated physical functioning
Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)
Measured: Baseline to 4, 8, and 24 weeks
Self-rated physical functioning (RMDQ)
Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability).
Measured: Baseline to 4, 8, 12, and 24 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).
Measured: Baseline to 4, 8, 12, and 24 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).
Measured: Baseline to 4, 8, 12, and 24 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.
Measured: Baseline to 4, 8, 12, and 24 weeks
Safety outcome
Number of serious adverse events (SAE) and adverse events (AE) that are deemed possibly, probably, or definitely related to the intervention (according to our protocol and ClinO, Art. 63, Switzerland).
Measured: During the 12 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudio Perret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudio Perret, Universität Luzern
- Investigators
- Claudio Perret, PhD, Principal investigator, University of Lucerne, University Research Centre Health and Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938568
- Sponsor's protocol ID
- 2024-01285
- Other IDs
- 63674
- Acronym
- LIFDI
- Status last verified
- May 2025
- First submitted
- 14 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is anticipated that the investigators will make encrypted individual participant data (IPD) available via a data repository and, additionally, upon reasonable request to the Principal Investigator. In both cases, only data from participants who have provided informed consent for data sharing will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06938568
- Acronym / sponsor ID
- LIFDI / 2024-01285
- Conditions
- Exercise Therapy, Low Back Pain
- Keywords
- Physical Functioning, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Claudio PerretUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Personalized medicine and individualized therapeutic approaches are prominent in current research. But are these approaches also effective for treating non-specific low back pain (NSLBP)? NSLBP is one of the most common musculoskeletal issues, which can impair physical well-being, reduce the quality of life, and limit physical functioning. Additionally, it contributes to substantial direct and indirect healthcare costs, such as frequent doctor visits and work absences. Despite NSLBP being a significant burden for both individuals and society, effective alleviation methods remain unclear. The investigators' research project therefore aims to investigate whether personalized therapy, specifically a personalized physical back training program, can effectively address NSLBP. Within the context of NSLBP, the investigators' specific aim is to improve physical functioning as this outcome is considered relevant from all perspectives, including those of patients, clinical professionals, researchers, and guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized back exercises | Experimental | Other: Personalized back exercisesThe study intervention is a 12-week personalized physical back training program. It consists of six to eight 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 back exercises | Active comparator | Other: Non-personalized back exercisesThe active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers)
- NSLBP for at least 6 weeks
- Activity limiting NSLBP (at least one activity with a PSFS Score of ≤ 50/100 on a scale from 0 = unable to perform due to NSLBP to 100 = able to perform at the same level as before NSLBP)
- Age between 18 and 65 years
- Understand the German language
Key exclusion criteria (8 listed)
- Specific LBP
- Red flags associated with any serious pathology or specific LBP,
- Being on a waiting list for or less than 12 months post any surgery of the lower back
- Pregnancy or given birth within the last 12 months
- Diagnosed central neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized back exercisesThe study intervention is a 12-week personalized physical back training program. It consists of six to eight 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. An initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups). | Other | Personalized back exercises |
| Non-personalized back exercisesThe active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight 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. An initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups). | Other | Non-personalized back exercises |
Primary outcome
Self-rated physical functioning
Time frame: Baseline to 12 weeks
Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)
6 secondary outcomes
Self-rated physical functioning
Time frame: Baseline to 4, 8, and 24 weeks
Self-rated physical functioning (RMDQ)
Time frame: Baseline to 4, 8, 12, and 24 weeks
Health-related quality of life (EQ-VAS)
Time frame: Baseline to 4, 8, 12, and 24 weeks
Health-related quality of life (EQ-5D-5L)
Time frame: Baseline to 4, 8, 12, and 24 weeks
Pain intensity (NRS)
Time frame: Baseline to 4, 8, 12, and 24 weeks
Safety outcome
Time frame: During the 12 week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: Yes. It is anticipated that the investigators will make encrypted individual participant data (IPD) available via a data repository and, additionally, upon reasonable request to the Principal Investigator. In both cases, only data from participants who have provided informed consent for data sharing will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudio Perret, PhD principal investigator
University of Lucerne, University Research Centre Health and Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized back exercises and Non-personalized back exercises in people with Exercise Therapy and Low Back Pain, run by Claudio Perret at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Perret, PhD (+41419396650, claudio.perret@unilu.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rated physical functioning (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.