Clinical Trials Directory

Trials / Completed

CompletedNCT04155970

The Biomechanical Effects of Manual Therapy - A Feasibility Study

In Patients With Acute Non-specific Low Back Pain, do Lumbar Inter-vertebral Motion Variables Change Following a Course of Manual Therapy: A Feasibility Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Bournemouth University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to determine the feasibility of conducting a full-scale trial to explore if there is a change in intervertebral movement following a course of manual therapy in patients with acute non-specific low back pain (NSLBP). Research Questions: 1. In patients with acute NSLBP, does lumbar intervertebral movement change following a course of manual therapy? 2. In patients with acute NSLBP, do those who respond to manual therapy (established by patient reported outcomes measures) have different intervertebral movement to those who do not?

Detailed description

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). The investigators 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 two weeks after baseline measurements.

Conditions

Interventions

TypeNameDescription
OTHERManual therapyManual therapy, which includes spinal manipulation; spinal mobilisation; light massage; and trigger point therapy.
OTHEREvidence-informed home management bookletThe home management booklet includes advice on posture, over the counter pain medication, cold and heat packs. The booklet also includes a section on patient reassurance and where to seek help from a medical professional in an emergency.

Timeline

Start date
2020-02-06
Primary completion
2021-03-19
Completion
2021-03-19
First posted
2019-11-07
Last updated
2021-03-25

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04155970. Inclusion in this directory is not an endorsement.