Sleep and Pain in Osteoarthritis

ConditionsOsteoarthritis (OA) of the Hip Osteoarthritis (OA) of the Knee

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Reading

About this trial

People with osteoarthritis and painful joints often report poor sleep, but poor sleep can also increase pain. There have been very few studies of sleep in osteoarthritis using physical measuring devices, but in other painful conditions many people report worse sleep in questionnaires than actual sleep measured using wristwatch devices called actigraphs. This is called sleep misperception. Sleep misperception may affect the amount of pain that people report. Sleep misperception could be influenced by negative factors such as pain catastrophising (a tendency to ruminate on pain and its consequences), but also positive factors such as resilience and optimism. People who do not sleep well also have increased levels of "inflammation" in their blood (C-Reactive Protein, or CRP) and reduced pain thresholds for example to pressure or heat when tested in the laboratory. The aims of this study are to compare questionnaire and actigraphy measures of sleep in people with hip and knee osteoarthritis to see if there is sleep misperception. It is anticipated that people who report worse subjective compared to objective sleep will report more pain and have higher pain catastrophising as well as lower pain thresholds and less positive personality characteristics such as resilience. Participants will be asked to complete questionnaires about pain and sleep, mood and resilience, and to wear a wrist sleep monitoring device continuously for 7 days and nights and a brief daily sleep, pain and mood questionnaire. Willing participants will be asked to provide a pinprick of blood to measure CRP (inflammation), and Quantitative Sensory Testing (QST) for pressure pain and thermal pain thresholds using a blunt nylon filament and a heat probe on one forearm. Information from this study will be used to inform the development of a psychological intervention designed to improve resilience, sleep reporting and potentially pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults over 18 years with hip or knee osteoarthritis or both, confirmed by clinical staff or self-report plus application of American College of Rheumatology (ACR) clinical criteria for osteoarthritis of the hip or knee at the time of screening.

Disqualifiers

Cognitive impairment

Participants who have already had hip or knee joint replacement surgery

Cancer which is not in remission

Other forms of arthritis for example rheumatoid arthritis

Trial population

Orthopaedic outpatients with hip or knee osteoarthritis attending clinic at Hampshire Hospitals NHS Foundation Trust, Basingstoke RG24 9NA, UK

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

Perceived sleep quality

This will be measures using The Pittsburgh Sleep Quality Index (PSQI) which records perceived sleep quality over the past 4 weeks using 19 items recorded on a 4-point scale. Increasing scores indicate worsening sleep quality.

Time frame

At recruitment

Severity of insomnia symptoms

The Insomnia Severity Index (ISI) will be used to record the the severity of insomnia symptoms and the consequences of sleep problems over the past 2 weeks. This is a 7-item questionnaire rated on a 5-point scale with higher scores indicating increasing severity of insomnia symptoms.

Time frame

At recruitment

Sleep duration (perceived)

Each morning for 7 mornings, participants will complete the Consensus AM sleep diary detailing their perceived sleep time in minutes. This number will be calculated by subtracting the time they woke up from the time they estimate that they went to sleep the night before.

Time frame

From the date of recruitment for up to 28 days after recruitment

Sleep duration (actigraphic)

Objective sleep duration in minutes will be recorded with a CamNTech MotionWatch 8 for 7 nights.

Time frame

From the date of recruitment for up to 28 days.

Secondary outcomes

Pain catastrophising

Pain catastrophising will be measured using the Pain Catastrophising Scale (PCS), a 13-item questionnaire with each item rated on a 5-point scale where higher values indicate higher levels of pain catastrophising. Pain catastrophising will be correlated with the level of pain and sleep misperception.

Time frame

At recruitment

Dysfunctional beliefs about sleep

Dysfunctional Beliefs About Sleep will be measured with the 16-item Dysfunctional Beliefs and Attitudes about Sleep questionnaire (DBAS-16) rated on an 11-point numerical rating scale with higher scores indicating higher dysfunctional beliefs about sleep.

Time frame

Up to 28 days after recruitment

Chronotype

Chronotype will be measured by the Reduced Morningness-Eveningness Questionnaire (rMEQ) a 5-item scale measured on a 4-point scale with higher scores indicating a greater preference for "morningness".

Time frame

Up to 28 days after recruitment

Sleep effort

Sleep Effort will be measured using the Glasgow Sleep Effort Scale, a 7-item questionnaire with 3 possible responses for each item according to the level of agreement regarding sleep effort, with higher scores indicating greater sleep preoccupation or worry about sleep and the amount of effort put into sleeping.

Time frame

At recruitment

Other outcomes

Demographics

Information regarding demographics will include site of osteoarthritis, age, sex, years of education, work including shift pattern, menopausal status, body mass index (BMI) by self-report, ethnicity, comorbidities including anxiety or depression, medication including supplements and HRT, smoking, caffeine and alcohol.

Time frame

At recruitment

Physical activity

A brief estimate of level of physical activity will be measured using the General Practice Physical Activity Questionnaire (GPPAQ)

Time frame

At recruitment

Health-related Quality of Life

This will be measured with the EuroQol 5-D (ED-5D-5L)

Time frame

Up to 28 days after recruitment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Reading

Lead sponsor

Hampshire Hospitals NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

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