Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain

NCT06938568 | Recruiting DMC

• 2 other identifiers: 2024-0128563674
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Physical Functioning; Exercise

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline to 12 weeks

Secondary Outcomes (6)

• Self-rated physical functioning

  Baseline to 4, 8, and 24 weeks

• Self-rated physical functioning (RMDQ)

  Baseline to 4, 8, 12, and 24 weeks

• Health-related quality of life (EQ-VAS)

  Baseline to 4, 8, 12, and 24 weeks

• Health-related quality of life (EQ-5D-5L)

  Baseline to 4, 8, 12, and 24 weeks

• Pain intensity (NRS)

  Baseline to 4, 8, 12, and 24 weeks

Other Outcomes (5)

• Pain frequency

  Baseline to 4, 8, 12, and 24 weeks

• Pain duration

  Baseline to 4, 8, 12, and 24 weeks

• Pain interference (PEG)

  Baseline to 4, 8, 12, and 24 weeks

Study Arms (2)

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.

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.

Other: Non-personalized back exercises

Interventions

Personalized back exercises OTHER

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).

Personalized back exercises

Non-personalized back exercises OTHER

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).

Non-personalized back exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Claudio Perret: lead

Study Sites (1)

University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre Health and Society

Lucerne, Canton of Lucerne, 6002, Switzerland

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Claudio Perret, PhD

  University of Lucerne, University Research Centre Health and Society

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Perret, PhD

CONTACT

+41419396650; claudio.perret@unilu.ch

Andrea M Aegerter, PhD

CONTACT

+41412295739; andrea.aegerter@unilu.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Claudio Perret

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: It is anticipated that the data will be made available as soon as possible after the completion of the study and will remain accessible for at least 10 years.
• Access Criteria: Access to the data will be granted in accordance with the criteria of the repository and/or publisher.

Locations

CH (1)