Chronic non-specific low back pain M54.5
Conditions
Interventions
Group 1: Participants in both exercise groups will follow similar exercise components (stabilization and resistance training) with different frequency protocols. Over the course of six weeks, particip
Sponsors
Hochschule Bochum
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: average pain intensity of at least 40 on the Visual Analog Scale
Exclusion criteria
Exclusion criteria: - Actively participating in moderate-vigorous exercises for more than 150 minutes per week - Currently receiving or have undertaken physiotherapy or exercise treatment for low back pain in the previous month - Unable to attend three training sessions per week and four testing sessions over the course of 12 weeks - Specific or radicular syndrome low back pain - Inability to communicate in English - Current pregnancy - Less than one-year post-partum - Current clinical diagnosis of severe depression, acute anxiety disorders, schizophrenia, or other severe mental health conditions - Stroke - Traumatic brain injury - Other absolute contraindications to exercise training - Unable to provide informed consent (e.g. cognitive impairment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disability (Oswestry Disability Index, ODI 2.1b) [Baseline, 3-week post-baseline, 6-week post-baseline (primary endpoint), 12-week post-baseline] Low back pain intensity (Visual Analogue Scale, VAS 0-100): a) current pain intensity, b) average pain this week, c) worst pain today and d) worst pain intensity in the last week [Baseline, end of each week, 6-week post-baseline (primary endpoint), 12-week post-baseline] | — |
Secondary
| Measure | Time frame |
|---|---|
| Fear-avoidance beliefs (Fear avoidance beliefs questionnaire, FABQ) [Baseline, 6-week post-baseline (primary endpoint), 12-week post-baseline] Health-related Quality of life (EuroQol-5 Dimensions-5 Levels questionnaire, EQ-5D-5L) [Baseline, 6-week post-baseline (primary endpoint), 12-week post-baseline] Weekly physical activity [International Physical Activity Questionnaire-short form, metabolic equivalent minutes per week] [Baseline] Feasibility measures: Safety (Number and categories of adverse events) [Continuously monitored during the 6-week intervention period] i. Intervention-related adverse events: Adverse events occurring during supervised exercise sessions and home-exercise sessions ii. Adverse events unrelated to the study intervention All adverse events will be recorded and classified according to the following criteria: a. Causality: all-cause adverse events or exercise-related adverse events b. Severity: whether mild, moderate or severe; required hospitalization or medical intervention c. Outcomes: recovery, ongoing symptoms, death d. Temporal association: time taken to occurrence of adverse events e. Type: musculoskeletal, cardiovascular, respiratory or other Adherence and attrition rates: frequency of session attendance and reasons for non-attendance. Intervention acceptability (expectations and satisfaction) Expectations related to the exercise intervention [Baseline, 6-week post-baseline (primary endpoint)] will be rated on a 1–5 scale for a 20-point (out of 100) pain relief, with 1 indicating ‘not at all likely’ and 5 indicating ‘extremely likely.’ Upon completion of treatment intervention, participants will rate whether their expectations were met on a 1-5 scale, where 1 indicates ‘definitely not’ and 5 indicates ‘definitely yes’. Clinical meaningfulness (number of clinical and home exercise sessions needed for a meaningful pain relief) [Baseline and 6-week post-baseline (primary endpoint] Satisfaction with the exercise dos | — |
Countries
Germany
Contacts
Public ContactNitin Kumar Arora
Hochschule Bochum
Outcome results
None listed