NCT04155970

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. 1.In patients with acute NSLBP, does lumbar intervertebral movement change following a course of manual therapy?
  2. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

November 1, 2019

Last Update Submit

March 24, 2021

Conditions

Low Back Pain, Mechanical

Keywords

Manual TherapyFluoroscopeMechanicsKinematics

Outcome Measures

Primary Outcomes (7)

  • Ratio of presenting patients and eligible patients

    Ratio of the number of patients seeking care for acute non-specific low back pain vs. number of eligible patients (according to eligibility criteria)

    1 year

  • Ratio of patients approached vs. number of participants who consent to trial

    Rate of conversion from number of patients approached (who are eligible for the trial) to number of participants who consent to be a part of the trial.

    1 year

  • Incidence of participant withdrawal

    Total participant number in the trial vs. number of participants who withdraw from the trial (where the participant withdraws from the trial)

    1 year

  • Incidence of participant being withdrawn

    Total participant number in the trial vs. number of participants who have been withdraw from the trial (where the practitioner withdraws the participant from the trial)

    1 year

  • Participant compliance in arm one

    Ratio of total participants in arm one vs. number of participants who were non-compliant with the intervention (in arm one)

    1 year

  • Participant compliance in arm two

    Ratio of total participants in arm two vs. number of participants who were non-compliant with the intervention (in arm two)

    1 year

  • Number of participants who experienced adverse or serious adverse events

    Ratio of total number of participants (in both groups) vs. serious adverse events, as well as adverse events.

    1 year

Secondary Outcomes (8)

  • Bournemouth Questionnaire

    2 weeks

  • Roland Morris Disability Questionnaire - 24

    2 weeks

  • Inter-vertebral range of angular motion

    2 weeks

  • Sagittal translation

    2 weeks

  • Laxity

    2 weeks

  • +3 more secondary outcomes

Study Arms (2)

Manual Therapy Arm

EXPERIMENTAL

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

Other: Manual therapyOther: Evidence-informed home management booklet

Non-Manual Therapy Arm

EXPERIMENTAL

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

Other: Evidence-informed home management booklet

Interventions

Manual therapyOTHER

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

Manual Therapy Arm
Evidence-informed home management bookletOTHER

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.

Also known as: Low back pain self help booklet
Manual Therapy ArmNon-Manual Therapy Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bournemouth University

Bournemouth, Dorset, BH12 5BB, United Kingdom

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Philip Sewell

    Head of Department - Design & Engineering

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor is blinded as to which intervention each participant received.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2019

First Posted

November 7, 2019

Study Start

February 6, 2020

Primary Completion

March 19, 2021

Study Completion

March 19, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Once the project is complete, the final anonymised dataset captured during the study will be uploaded to BORDaR (Bournemouth Online Research Data Repository). This is in the interest of open data sharing.

Shared Documents
CSR
Time Frame
An embargo will be placed on the final dataset until the study (and PhD) is complete and the results of the study have been published. In the interest of open data sharing, the data will be available indefinitely.
Access Criteria
Request for anonymised dataset will need to be submitted through BORDaR (Bournemouth Online Research Data Repository)
More information

Locations

GB(1)