What Are Persistent Lower Back Pain Patients' Views of Sleep Health Within an Outpatient Musculoskeletal Physiotherapy Setting?

NCT ID: NCT06094517

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-04-17

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.

Detailed Description

Background:Approximately one third of western populations suffer from sleep disturbance at least once a week and with 6-10% meeting the threshold of insomnia (National Institute of Clinical Excellence, 2022). The estimated population of the United Kingdom (UK) affected by insomnia is 37% (Morphy et al., 2007). Diminished sleep is associated with increased pain perceptions, reduced pain thresholds, physical activity levels, immune function, cognition and quality of life. Moreover, a lack of sleep correlates with increased prevalence of diabetes, obesity, cardiovascular disease, depression, and mortality (Medi, Wille & Hemels, 2017).

Over 90% of patients with Persistent Lower Back Pain (PLBP) receiving physiotherapy are affected by sleep disturbance (Roseen et al., 2020).Conventional Physiotherapy rehabilitation has shown effective in improving sleep quality in patients with PLBP as measured via Pittsburgh Sleep Quality Index (PSQI). However, Eadie et al. (2013) & Roseen et al., (2020). There is a paucity of research exploring Physiotherapies role within sleep health. Equally, studies specific to Physiotherapies role are mainly reviewed from the clinician's perspective, with a scarceness of studies providing insight into the patient perspective. To date, no studies have canvassed the opinion of patients in Physiotherapy care on the profession's role in sleep health, creating a strong footing for the proposed investigation Physiotherapist place a high value on the importance of sleep health but struggle to provide inventions citing a lack of training, resource and time. The evidence based is heavily survey based and of a quantitative nature, lacking explanation of why barriers exist, warranting further qualitative investigation (Caudwell et al. 2020 and Siengsukon, Nelson & Turkowitch 2023)

It is unclear how PLBP patients with sleep disturbance want to utilize their time in Physiotherapy care and their perceptions of Physiotherapies role within the management of sleep health (Siengsukon, Nelson & Turkowitch 2023). The proposed study would be the first to be conducted in the UK, examining PLBP patients' expectations of sleep health management within outpatient MSK physiotherapy setting.

Design and Methods:Qualitative in nature, via individual semi-structured interviews, will allow the study to explore participants' feelings and beliefs (De Jonckheere & Vaughn, 2019). The study topic is novel in design and will allow the capture of rich data and themes (Lincoln & Guba, 1985), current evidence base lacks qualitative data, especially from a patient perspective(Caudwell et al. 2020).

Recruitment and Sample Size: Recruitment will occur until the point of data saturation is reached and new themes have stopped emerging. Dickerson, Klingman & Jungquist (2016) comparable study found that interviewing 29 participants on the "Common meanings of good and bad sleep" met saturation point. Given their much wider focus, it is anticipated that interviewing 8-12 participants would meet data saturation in the proposed study. This will be reviewed for adequacy concurrently with data collection (De Jonckheere & Vaughn 2019 and Malterud, Siersma & Guassora, 2016).

Data-Collection: Semi-structured interviews will be directed by the interview guide. Transcriptions will then be reviewed and corresponded to interview notes taken to ensure accuracy. Further secondary outcome measures PSQI and Pain, Enjoyment of Life and General Activity Scale, will be collected prior to interviews via Google Forms Surveys.

Data Analysis: Data analysis will be completed by the principal investigator via a Reflexive Thematic Analysis approach.

• Dataset Familiarisation
• Data Coding
• Initial Theme Generation
• Theme Development and Review
• Theme Refining
• Writing Up

Reflexive Thematic Analysis provides a structured systematic process for the recognition of themes. It recognises the background of the research and celebrates their insight into the topic, allowing for meaningful generation of themes. Although themes should occur multiple times within the data, this approach allows for the relevance and quality of the data provided to best answer the research question as opposed to prevalence alone. To ensure rigour, prior to completing the trial practice interview with Senior Physiotherapist interested in sleep health and reviewed for appropriateness. During the interview and coding processes, a reflective log will be kept by the principal researcher, appraising their performance within the data collection and considering personal bias (Campbell et al., 2021). To ensure consistency, the interviews, initial coding and theme generation will be conducted by the Principal Investigator. Appropriateness will be reviewed by the First Supervisor.

Conditions

Persistent Lower Back Pain; Sleep Disturbance; Lower Back Pain; Chronic Low-back Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Interview

Intervention Type: OTHER

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

Interventions

Interview

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

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

Sponsors

Chesterfield Royal Hospital NHS Foundation Trust

UNKNOWN

Sponsor Role: collaborator

Sheffield Hallam University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clive Smith, BSc

Role: CONTACT

clivesmith1@nhs.net

01246512178

Simon O'Shea, MSc

Role: CONTACT

simonoshea@nhs.net

0114 237 1030

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 17425223 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28579842 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31667747 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23643716 (View on PubMed)

Lincoln, Y. S., & Guba, E. G. (1985). Naturalistic inquiry. Sage

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 37269038 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32148704 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29073430 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26613970 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

PLBP paitent view sleep Phyiso

Identifier Type: -

Identifier Source: org_study_id