Clinical trial NCT06921694: A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain: a Randomised-controlled Study
Official title: A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain: a Randomised-controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain, Chronic
Keywords: chronic non specific low back pain
exercise intervention
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will recruit from the community otherwise healthy participants with low back pain to take part in an 8 week intervention. There are 3 arms - a control arm of usual exercise; a running intervention group; and a swim/cycle intervention group. The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running or swim/cycle), a schedule of gradually intensifying strengthening exercises and flexibility exercises. There are baseline, 8 week and 1 year questionnaires including validated PROMS to determine pain and function.

Detailed description: This study will recruit from the community otherwise healthy participants with low back pain to take part in an 8 week intervention. There are 3 arms - a control arm of usual exercise; a running intervention group; and a swim/cycle intervention group. The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running or swim/cycle), a schedule of gradually intensifying strengthening exercises and flexibility exercises. There are baseline, 8 week and 1 year questionnaires including validated PROMS to determine pain and function.

Eligibility criteria: Inclusion Criteria:

* Aged 18-45 years
* Participant is willing and able to give informed consent for participation in the study
* Suffering from chronic NSLBP (more than 3 months, localised below the costal margin and above the gluteal folds)
* Suffers from pain or functional limitations as a result of their LBP (minimum VAS (back) score of 3/10 or ODI score of at least 5/50 or RMD score of at least 5/24 (note, unlike ODI, RMD does not describe specific cuts offs for different levels of disability)
* Able to exercise

Exclusion Criteria:

* Radiating pain to leg / sciatica / acute radiculopathy
* Specific diagnosis/condition for LBP (e.g. herniated disk, degenerative disk disease, spondylolysis, spinal stenosis, spinal tumour, facet joint damage)
* History of osteoporosis , arthritis, scoliosis, or kyphosis.
* Current spinal infection, cancer or a current fracture (any bone).
* History of spinal/back surgery
* Unable to participate in physical activity and exercise
* Pregnant or breast feeding
* History of substance abuse
* History of psychiatric illness (eg. depression, dementia, schizophrenia) for which currently taking medication
* History or current neurological condition (e.g. epilepsy)
* Not in possession or have access to adapted equipment (phone, computer, functioning WIFI)
* Unable to understand and communicate in English
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Primary outcomes:
measure: VAS pain score
timeFrame: Baseline, 8 weeks, 12 months
measure: Oswestry disability index
timeFrame: Baseline, 8 weeks, 12 months
measure: Roland Morris Disability questionnaire
timeFrame: Baseline, 8 weeks, 12 months
Secondary outcomes:
measure: Exercise data
timeFrame: During the 8 week intervention (weekly)
Other outcomes:
measure: Adherence
timeFrame: During the 8 week intervention (weekly)
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham, Queen's Medical Centre
state: Notts
Study officials:
affiliation: University of Nottingham
name: Kimberley Edwards
role: PRINCIPAL_INVESTIGATOR
References: