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

Sponsor

Sheffield Hallam University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06094517

Collaborator

Chesterfield Royal Hospital NHS Foundation Trust (Other)

Enrollment

4.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Persistent Lower Back Pain Sleep Disturbance Lower Back Pain Chronic Low-back Pain	Other: Interview

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

What Are Persistent Lower Back Pain Patients' Views of Sleep Health Within an Outpatient

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Mar 15, 2024

Anticipated Study Completion Date :

Apr 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Thematic Analysis [Completed one within 2 week of recruitment to trial]
Thematic Analysis of Data from semi structured interview

Secondary Outcome Measures

Pittsburgh Sleep Quality Index [Completed one within 2 week of recruitment to trial]
Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval
Pain, Enjoyment of Life and General Activity Scale (PEG Scale) [Completed one within 2 week of recruitment to trial]
Self-rated questionnaire which assesses Pain, Enjoyment of Life and General Activity via 3 separate visual analogue scales.