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A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain

ConditionLow Back Pain, Chronic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Nottingham

About this trial

This randomised controlled trial will evaluate the effectiveness of different exercise modalities for individuals with low back pain. Participants will be allocated to one of three groups: a control arm (usual exercise), a running-based intervention, or a swimming/cycling-based intervention. Outcomes related to pain and function will be measured at baseline, 8 weeks, and 12 months.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Runner group

    Behavioral

    The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running), a schedule of gradually intensifying strengthening exercises and flexibility exercises

  • Swim/Cycle Group

    Behavioral

    The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (swim/cycle), a schedule of gradually intensitfing strengthening exercises and flexibility exercises

Treatment groups

88 Participants
are divided into 3 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Runner GroupExperimental treatment 1 intervention
Group C: Swim/Cycle groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

VAS pain score

VAS pain score on 100 point scale * Range: 0 to 100 * Anchors: 0 = no pain, 100 = worst imaginable pain * Interpretation: Higher scores indicate worse pain

Time frame
Baseline, 8 weeks, 12 months

Secondary outcomes

1

Oswestry disability index

Oswestry disability index (PROM questionnaire) * Range: 0 to 100 (expressed as a percentage) * Anchors: 0 = no disability, 100 = maximum disability * Interpretation: Higher scores indicate greater disability

Time frame
Baseline, 8 weeks, 12 months
2

Roland Morris Disability questionnaire

Roland Morris Disability questionnaire (PROM questionnaire) * Range: 0 to 24 (some versions extend to 0-23 or 0-25 depending on adaptation, but 0-24 is most common) * Anchors: 0 = no disability, 24 = maximum disability * Interpretation: Higher scores indicate greater disability

Time frame
Baseline, 8 weeks, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nottingham

Lead sponsor

Source ClinicalTrials.gov
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