The Biomechanical Effects of Manual Therapy - A Feasibility Study

NCT ID: NCT04155970

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-06
• Study Completion Date: 2021-03-19

Brief 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

Low Back Pain, Mechanical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Manual Therapy Arm

The group will receive manual therapy, as well as an evidence-informed home management booklet.

Group Type: EXPERIMENTAL

Manual therapy

Intervention Type: OTHER

Manual therapy, which includes spinal manipulation; spinal mobilisation; light massage; and trigger point therapy.

Evidence-informed home management booklet

Intervention Type: OTHER

The 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.

Non-Manual Therapy Arm

The group will receive an evidence-informed home management booklet only.

Group Type: EXPERIMENTAL

Evidence-informed home management booklet

Intervention Type: OTHER

The 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.

Interventions

Manual therapy

Manual therapy, which includes spinal manipulation; spinal mobilisation; light massage; and trigger point therapy.

Intervention Type: OTHER

Evidence-informed home management booklet

The 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.

Intervention Type: OTHER

Other Intervention Names

Low back pain self help booklet

Eligibility Criteria

Inclusion Criteria

• Patients with acute non-specific low back pain (NSLBP), without leg pain, of at least 2 weeks duration, but no more than 4 weeks duration
• Patients between the ages of 18 and 65

Exclusion Criteria

• Patients who cannot understand written English and unable to provide full informed consent.
• Patients who are currently involved in another research study
• Patients with a BMI over 30 (less likely to obtain the required information from the images)
• Pregnancy or potentially pregnant
• Previous ionising radiation exposure within the last 6 months greater than 8mSv.
• Previous lumbar spine surgery, as well as recent abdominal or pelvic surgery (within the last 12 months).
• Scoliosis or positive Adams forward Bending Test for Scoliosis.
• Diagnosed Osteoporosis (Bone Density Scan)
• Patients with a numeric pain scale of 8 or more, or 2 or less, taken at the New Patient Examination Appointment.
• Manual therapy already received for this episode of NSLBP
• Litigation or compensation pending
• Diagnosis of depression (by a medical doctor) within the last 12 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AECC University College

UNKNOWN

Sponsor Role: collaborator

Bournemouth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Sewell

Role: STUDY_CHAIR

Head of Department - Design & Engineering

Locations

Bournemouth University

Bournemouth, Dorset, United Kingdom

Countries

United Kingdom

Other Identifiers

Version 1.0

Identifier Type: -

Identifier Source: org_study_id