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

NCT06540911 | Completed DMC

• 2 other identifiers: 2024-0128463674
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Exercise Therapy; Exercise; Low Back Pain

Keywords

Exercise; Low Back Pain; Physical Functioning

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Self-rated physical functioning (PSFS)

  Baseline to 4 weeks

• Self-rated physical functioning (RMDQ)

  Baseline to 4 weeks

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

  Baseline to 4 weeks

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

  Baseline to 4 weeks

• Pain intensity (NRS)

  Baseline to 4 weeks

Other Outcomes (11)

• Pain frequency

  Baseline to 4 weeks

• Pain duration

  Baseline to 4 weeks

• Pain interference (PEG)

  Baseline to 4 weeks

Study Arms (2)

Personalized physical back training program

EXPERIMENTAL

4-week personalized physical back training program

Other: Personalized physical back training program

Non-personalized physical back training program

ACTIVE COMPARATOR

4-week non-personalized physical back training program

Other: Non-personalized physical back training program

Interventions

Personalized physical back training program OTHER

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.

Personalized physical back training program

Non-personalized physical back training program OTHER

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.

Non-personalized physical back training program

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universität Luzern: lead
• Luzerner Kantonsspital: collaborator

Study Sites (1)

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

Lucerne, Canton of Lucerne, 6002, Switzerland

Location

MeSH Terms

Conditions

Motor Activity; Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Claudio Perret, Prof.

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

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 6, 2024
• Study Start: October 2, 2024
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available from the completion of the study for at least 10 years.
• Access Criteria: Access to the data will be granted according to the repository and/or publisher's criteria.

Locations

CH (1)