NCT06094517

Brief Summary

The goal of this qualitative is to understand the views and opinions of patients with persistent lower back pain patients who are awaiting physiotherapy treatment with regards sleep their sleep health. The main questions it aims to answer are:

  • Identify whether Patients with persistent lower back pain awaiting physiotherapy consider sleep health relevant to their condition.
  • Understand whether persistent lower back pain patients awaiting physiotherapy consider sleep health within the remit of Physiotherapy?
  • Understand how persistent lower back pain patients may want sleep health to be assessed or managed within an outpatient musculoskeletal Physiotherapy Setting? Participants will undertake one semi structured interview and complete two secondary outcome measures: Pittsburgh Sleep Quality Index and Pain, Enjoyment of Life and General Activity Scale. Data will be analysed via Thematic Analysis.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

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

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2024

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 16, 2023

Last Update Submit

October 16, 2023

Conditions

Keywords

PhysiotherapyPersistent Lower Back PainSleep DisturbanceLower Back PainChronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

  • Thematic Analysis

    Thematic Analysis of Data from semi structured interview

    Completed one within 2 week of recruitment to trial

Secondary Outcomes (2)

  • Pittsburgh Sleep Quality Index

    Completed one within 2 week of recruitment to trial

  • Pain, Enjoyment of Life and General Activity Scale (PEG Scale)

    Completed one within 2 week of recruitment to trial

Study Arms (1)

Observed Group

Patients with persistent lower back pain awaiting Physiotherapy care, undergoing interviews to assess their views of sleep health within and musculoskeletal outpatient Physiotherapy setting.

Other: Interview

Interventions

Persistent Lower Back Pain Patients on waiting list under going a usual care pathway following referral to Physiotherapy will be interviewed for views on sleep health

Observed Group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be identified from self-referrals and General Practitioner (GP) referrals to outpatient Musculoskeletal Physiotherapy at Chesterfield Royal Hospital NHS Foundation Trust, Meeting the Inclusion / exclusion criteria.

You may qualify if:

  • On waiting list for Outpatient MSK Physiotherapy at Chesterfield Royal Hospital NHS Foundation Trust
  • PLBP (present ≥ 3 months)
  • Patients ≥ 18 years

You may not qualify if:

  • Not fluent in English
  • Failure to understand study
  • Previous spinal surgery
  • Serous spinal pathology such as fractures or metastasis
  • Inflammatory Arthritis
  • Referral of pain below buttock
  • Acute mental health episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • National Institute of Clinical Excellence. (2022). Insomnia. CKS. https://cks.nice.org.uk/topics/insomnia/background-information/prevalence

    BACKGROUND
  • Morphy H, Dunn KM, Lewis M, Boardman HF, Croft PR. Epidemiology of insomnia: a longitudinal study in a UK population. Sleep. 2007 Mar;30(3):274-80.

    PMID: 17425223BACKGROUND
  • Medic G, Wille M, Hemels ME. Short- and long-term health consequences of sleep disruption. Nat Sci Sleep. 2017 May 19;9:151-161. doi: 10.2147/NSS.S134864. eCollection 2017.

    PMID: 28579842BACKGROUND
  • Roseen EJ, Gerlovin H, Femia A, Cho J, Bertisch S, Redline S, Sherman KJ, Saper R. Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):167-176. doi: 10.1007/s11606-019-05329-4. Epub 2019 Oct 30.

    PMID: 31667747BACKGROUND
  • Eadie J, van de Water AT, Lonsdale C, Tully MA, van Mechelen W, Boreham CA, Daly L, McDonough SM, Hurley DA. Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial. Arch Phys Med Rehabil. 2013 Nov;94(11):2083-92. doi: 10.1016/j.apmr.2013.04.017. Epub 2013 May 2.

    PMID: 23643716BACKGROUND
  • Lincoln, Y. S., & Guba, E. G. (1985). Naturalistic inquiry. Sage

    BACKGROUND
  • Caudwell, L., Himani, H., Khaw, A., Taylor, R., White, J., Rhodes, S., & Skinner, M. (2020). Attitudes and perceptions of health professionals towards sleep health: A systematic review. Physical Therapy Reviews, 25(5-6), 361-380.

    BACKGROUND
  • Siengsukon CF, Nelson E, Turkowitch D. Barriers and Facilitators to Implementing Sleep Health into Outpatient Physical Therapist Practice: A Survey Study. J Allied Health. 2023 Summer;52(2):e55-e61.

    PMID: 37269038BACKGROUND
  • DeJonckheere M, Vaughn LM. Semistructured interviewing in primary care research: a balance of relationship and rigour. Fam Med Community Health. 2019 Mar 8;7(2):e000057. doi: 10.1136/fmch-2018-000057. eCollection 2019.

    PMID: 32148704BACKGROUND
  • Dickerson SS, Klingman KJ, Jungquist CR. Common meanings of good and bad sleep in a healthy population sample. Sleep Health. 2016 Sep;2(3):253-259. doi: 10.1016/j.sleh.2016.06.004. Epub 2016 Jul 30.

    PMID: 29073430BACKGROUND
  • Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016 Nov;26(13):1753-1760. doi: 10.1177/1049732315617444. Epub 2016 Jul 10.

    PMID: 26613970BACKGROUND
  • Campbell, K. A., Orr, E., Durepos, P., Nguyen, L., Li, L., Whitmore, C., ... & Jack, S. M. (2021). Reflexive thematic analysis for applied qualitative health research. The Qualitative Report, 26(6), 2011-2028.

    BACKGROUND

MeSH Terms

Conditions

ParasomniasLow Back Pain

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Clive Smith, BSc

CONTACT

Simon O'Shea, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

December 1, 2023

Primary Completion

March 15, 2024

Study Completion

April 17, 2024

Last Updated

October 23, 2023

Record last verified: 2023-10