Exercise TherapyLIFDINCT06540911

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

A study testing Personalized physical back training program and Non-personalized physical back training program in people with Exercise Therapy and Exercise, run by Universität Luzern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Exercise Therapy, Exercise, Low Back Pain
What is being tested?: Personalized physical back training program and Non-personalized physical back training program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteSwitzerland
Study dates: 2 Oct 2024to 19 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

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

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.

Who cannot join

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,

Show all 12Show fewer

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 locations and contacts

1 site in 1 country.

Switzerland1 site

University of Lucerne, Faculty of Health Sciences and Medicine, Universitäres Forschungszentrum Gesundheit und Gesellschaft
Lucerne, Canton of Lucerne, 6002

Other trials in Switzerland

About this study

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
Being tested: Personalized physical back training program, Non-personalized physical back training program
Keywords: Exercise, Low Back Pain, Physical Functioning
Medical subject headings: Motor Activity, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Personalized physical back training programOther
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 programOther
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.

Study groups in NCT06540911
Study group	Role	What they receive
Personalized physical back training program	Experimental	4-week personalized physical back training program Receives: Other: Personalized physical back training program
Non-personalized physical back training program	Active comparator	4-week non-personalized physical back training program Receives: Other: Non-personalized physical back training program

What is being measured

The primary outcome is the main question the study is designed to answer.

Logistical and operational feasibility: Response time
Response time (in days).
Measured: Baseline
Logistical and operational feasibility: Recruitment capability
Ratio of invited individuals to included participants.
Measured: Baseline
Logistical and operational feasibility: Sample characteristics
Analyze sample characteristics (e.g., gender, age) using descriptive statistics.
Measured: 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.
Measured: Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Questionnaire)
Qualitatively evaluate the usability of the questionnaire through interviews.
Measured: Baseline to 4 weeks
Logistical and operational feasibility: Data collection procedures (Clinical Assessment)
Qualitatively evaluate the usability of the clinical assessment through interviews.
Measured: 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.
Measured: Baseline to 4 weeks
Logistical and operational feasibility: Resource management
Qualitatively evaluate the time and personnel required for conducting the study through interviews.
Measured: Baseline to 4 weeks

Secondary outcomes (6)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: During the 4 week intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 202419 Dec 2024

First posted6 Aug 2024
Study start2 Oct 2024
Primary completion19 Dec 2024
Study completion19 Dec 2024

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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06540911
Sponsor's protocol ID: 2024-01284
Other IDs: 63674
Acronym: LIFDI
Status last verified: Dec 2024
First submitted: 19 Jul 2024
Last updated: 20 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The investigators plan to make encrypted individual participant data (IPD) available through a repository and/or via publications, such as supplementary materials

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
Hyperkyphosis, Adolescent
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Prostate Carcinoma
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension

All Exercise Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2024. 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: a Feasibility Study
ClinicalTrials.gov ID: NCT06540911
Acronym / sponsor ID: LIFDI / 2024-01284
Conditions: Exercise Therapy, Exercise, Low Back Pain
Keywords: Exercise, Low Back Pain, Physical Functioning
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Universität LuzernUniversity, hospital or other
Collaborators: Luzerner Kantonsspital
Study start: 2 Oct 2024 (actual)
Primary completion: 19 Dec 2024 (actual)
Study completion: 19 Dec 2024 (actual)
First posted: 6 Aug 2024 (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.

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 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 physical back training program	Experimental	Other: Personalized physical back training program4-week personalized physical back training program
Non-personalized physical back training program	Active comparator	Other: Non-personalized physical back training program4-week non-personalized physical back training program

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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,

Key exclusion criteria (12 listed)

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,

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 physical back training programThe 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.	Other	Personalized physical back training program
Non-personalized physical back training programThe 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.	Other	Non-personalized physical back training program

Primary outcome

Logistical and operational feasibility: Response time
Time frame: Baseline
Response time (in days).
Logistical and operational feasibility: Recruitment capability
Time frame: Baseline
Ratio of invited individuals to included participants.
Logistical and operational feasibility: Sample characteristics
Time frame: Baseline to 4 weeks
Analyze sample characteristics (e.g., gender, age) using descriptive statistics.
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.
Logistical and operational feasibility: Data collection procedures (Questionnaire)
Time frame: Baseline to 4 weeks
Qualitatively evaluate the usability of the questionnaire through interviews.
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.
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.
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.

6 secondary outcomes

Self-rated physical functioning (PSFS)
Time frame: Baseline to 4 weeks
Self-rated physical functioning (RMDQ)
Time frame: Baseline to 4 weeks
Health-related quality of life (EQ-VAS)
Time frame: Baseline to 4 weeks
Health-related quality of life (EQ-5D-5L)
Time frame: Baseline to 4 weeks
Pain intensity (NRS)
Time frame: Baseline to 4 weeks
Intervention-related (serious) adverse events
Time frame: During the 4 week intervention period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
Individual participant dataSharing planned: Yes. The investigators plan to make encrypted individual participant data (IPD) available through a repository and/or via publications, such as supplementary materials

Related trials for Exercise Therapy

Enrolling by invitation
Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
Hyperkyphosis, Adolescent
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Prostate Carcinoma
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension

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. This study is not recruiting at the moment.

Claudio Perret, Prof. principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 12 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: finished, as of the sponsor's last update on 20 Dec 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Logistical and operational feasibility: Response time (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06540911.

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 20 Dec 2024.