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Completed

NCT Number: NCT06540911

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

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.

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Key information

Conditions

Exercise Therapy Back Pain Behavior Exercise Low Back Pain Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lucerne, Canton of Lucerne, 6002, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Logistical and operational feasibility: Response time

    Time frame: Baseline

    Response time (in days).

  2. Logistical and operational feasibility: Recruitment capability

    Time frame: Baseline

    Ratio of invited individuals to included participants.

  3. Logistical and operational feasibility: Sample characteristics

    Time frame: Baseline to 4 weeks

    Analyze sample characteristics (e.g., gender, age) using descriptive statistics.

  4. 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.

  5. Logistical and operational feasibility: Data collection procedures (Questionnaire)

    Time frame: Baseline to 4 weeks

    Qualitatively evaluate the usability of the questionnaire through interviews.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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).

Other outcomes

  1. Pain frequency

    Time frame: Baseline to 4 weeks

    Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days.

  2. 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.

  3. 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.

  4. Pain extent

    Time frame: Baseline to 4 weeks

    Change in pain extent. Percentages of the body with NSLBP, with 0%=minimum

  5. Performance-based physical functioning (pressure pain threshold)

    Time frame: Baseline to 4 weeks

    Change in pressure pain threshold. kPA, with 0=minimum

  6. Performance-based physical functioning (range of motion)

    Time frame: Baseline to 4 weeks

    Change in range of motion. Degrees, with 0=minimum

  7. Performance-based physical functioning (strength)

    Time frame: Baseline to 4 weeks

    Change in strength. Nm, with 0=minimum

  8. Performance-based physical functioning (neurodynamics)

    Time frame: Baseline to 4 weeks

    Change in neurodynamics. Positive, negative.

  9. Performance-based physical functioning (movement control)

    Time frame: Baseline to 4 weeks

    Change in movement control. Positive, negative.

  10. 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.

  11. 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).

Sponsors and collaborators

Lead sponsor

Universität Luzern

Other

Collaborators

  • Luzerner Kantonsspital

Registry information

Acronym: LIFDI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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