The Biomechanical Effects of Manual Therapy - A Feasibility Study

• Research type

  Research Study

• Full title

  The Biomechanical Effects of Spinal Manipulation - A Feasibility Study

• IRAS ID

  271970

• Contact name

  Jacqueline Rix

• Contact email

  rixj@bournemouth.ac.uk

• Sponsor organisation

  Bournemouth University

• Clinicaltrials.gov Identifier

  NCT04155970

• Duration of Study in the UK

  1 years, 8 months, 16 days

• Research summary

  Research Summary:
  Non-specific low back pain (NSLBP) is a leading cause of disability and work-days lost worldwide. Yet, in most cases we do not know the specific cause. It is thought to be due to abnormal movement between the spinal bones (vertebrae). We can now measure movement between vertebrae using low-dose quantitative fluoroscopy (QF), or motion x-ray videos. QF is a reliable method of measuring spinal movement which is non-invasive and does not expose the patient to a lot of radiation. In this study, QF will be used as a measuring tool to measure spinal movement in patients with acute NSLBP before manual therapy versus after manual therapy to explore if there is a change in spinal movement. Research suggests that some patients respond to manual therapy and some do not, a secondary question in this study is to explore if there are differences in spinal movement between those who respond to manual therapy (measured using pain and disability questionnaires) and those who do not.
  This study is a feasibility study to determine whether the study can be carried out as a full-scale trial. Participants will be recruited from the AECC University College (AECC UC) Clinic. Following an examination, patients with acute low back pain, and who are eligible for the study will be invited to join. Participants will proceed with initial measurements which include validated questionnaires and QF. Following these measurements participants will be randomised into two groups, each containing 15 participants. Both groups will receive an evidence-informed home management booklet, the manual therapy group will receive five manual therapy treatments in two weeks. Participants will return for follow-up measurements.

  Summary of Results:
  The study was a feasibility study. Ten percent of all LBP patients presenting to the AECC UC Clinic would be eligible for a full-scale trial. The number of eligible patients presenting to the clinic may be insufficient to complete a full-scale trial timeously. Equally, only 57% of all eligible patients consented to join the trial. For this reason, the trial may not be feasible as a single-site trial, but potentially more feasible as a multi-site trial or with additional local participant identifying sites.
  The study also aimed to create a blueprint for a future full-scale trial. Due to the small sample size the study was underpowered and as such inferences from the data analysis should not be made. However, some recommendations for a future trial were made in terms of recommended outcomes measures and methods.
  The feasibility study formed part of a PhD thesis, and as such the thesis will be made available following completion

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  20/EE/0001

• Date of REC Opinion

  6 Feb 2020

• REC opinion

  Further Information Favourable Opinion