NCT04968444

Brief Summary

This research is aiming to address whether a group workshop is a more superior treatment to traditional physiotherapy for the management of back pain in a hospital workforce. In the UK during 2016-17, 31.2 million work days were lost due to work-related ill health and injury. Of these 8.9 million were down to musculoskeletal disorders. This equated to 17.6 days per person. In the general population, the reports of low back pain have been as high as 36% of adults with a first occurrence. In an adult's lifetime, the prevalence of chronic low back pain is about 23%. This makes the importance of managing these conditions of great importance. And the impact to a working population is great, in respects to work satisfaction, sickness and absenteeism. Significance should also be placed on the impact this has to the individual, with regards to their health and wellbeing. The participants will be taken from NHS staff working within the hospital environment and that self-refer internally for physiotherapy into the Trust's Occupational Health Service. Once the participants are accepted in Occupational Health Physiotherapy, they are managed as staff requiring physiotherapy and not at 'patients'. There is no contact with their primary care practitioner. For the study, participants will either receive traditional one to one physiotherapy or a bespoke one off workshop. All of the participants will be followed up 3 months after their treatment has finished.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

July 20, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

December 3, 2020

Last Update Submit

July 16, 2021

Conditions

Keywords

occupational healthphysiotherapysickness

Outcome Measures

Primary Outcomes (1)

  • The Keele STarT Back Screening tool

    score out of 9, for low, medium of high risk of chronicity of back pain

    Baseline

Secondary Outcomes (3)

  • Numerical rating score

    baseline and at 3 months following this

  • Patient Specific Functional Score

    baseline and at 3 months following this

  • sickness

    baseline and at 3 months following this

Study Arms (2)

one to one traditional physiotherapy

ACTIVE COMPARATOR

For clarity, 1-1 physiotherapy takes the form of a private consultation between patient and therapist. A discussion of symptoms is had and an individual physical examination is undertaken to explore what is mechanically causing their pain and what can be offered to help. This is also when the initial outcome scores are taken. Treatments are then offered which can take the form of exercise therapy, massage, and manual therapy. Symptoms are regularly monitored for effectiveness of treatment and adjusted accordingly. The number of sessions that forms their treatment is variable depending on response to treatment and how they are coping. At the final session the end outcome scores will be taken.

Other: Physiotherapy

BOOST workshop group

ACTIVE COMPARATOR

The BOOST workshop is a novel approach whereby participants are invited to a 2.5 hour interactive session. Subjective discussion at the start is had about how people are affected and impacted by their back pain, and outcome scores are completed. Then during the 2.5 hours there is a delivery of information and a practical exercise component to better inform the participants on how to manage their back pain and understand it better. Following this on 3 separate occasions, 1 month apart further top up information is sent to ensure they remember exercises and advice on practical management if a flare up occurs or they are struggling to fit activity in to day to day routines. Finally, at 3 months, there participants are invited back to complete the outcomes scores but also to discuss any concerns they are having and be given any advice to support them continuing with managing with any ongoing symptoms.

Other: Back Pain Workshop

Interventions

Physiotherapy helps to restore movement and function when someone is affected by injury, illness or disability. It can also help to reduce your risk of injury or illness in the future. This can take the form of * advice and education * manual therapy * exercise prescription * relaxation

one to one traditional physiotherapy

Back workshop is an intervention protocol consisting of an educational program and skills acquisition program, including physical exercises. The session is supervised by a specialist physiotherapist.

BOOST workshop group

Eligibility Criteria

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

You may not qualify if:

  • Staff member of GSTFT
  • New referral with a history of spinal pain (cervical/ thoracic/ lumbar) for more than 3 months
  • Consents to attend 2 sessions - seminar and follow up if in BOOST workshop, or complies with one to one treatment as outlined by the treating therapist.
  • Acute spinal pain - that of 6 weeks or less
  • Had treatment for the condition of chronic spinal pain in last 6 months as may still be gaining treatment benefits from this and unclear if change was due to our interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
blinding of investigator through masking of participant identified to each group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

July 20, 2021

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

August 31, 2024

Last Updated

July 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

This is an individual study on a single site. No plan to share as information is confidential