Pain-LESS Study

Not Applicable

• Conditions: Fibromyalgia; Musculoskeletal Diseases

• Registration Number: ISRCTN51854714
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-19
• Last Update Posted: 13 November 2023
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

Current participant inclusion criteria as of 31/10/2023:
1. Participant is willing and able to give informed consent for participation in the study.
2. Clinical diagnosis of fibromyalgia/chronic widespread pain
3. For feasibility study
3.1. Concomitant insomnia, frequent waking in the night or early morning waking
3.2. Self-reported difficulties with concentration or memory
3.3. Reliable Internet access

Previous participant inclusion criteria:
1. Participant is willing and able to give informed consent for participation in the study.
2. Clinical diagnosis of either inflammatory arthritis or fibromyalgia/chronic widespread pain

Exclusion Criteria

Current participant exclusion criteria as of 31/10/2023:
1. Patients from vulnerable groups
2. Patients with a poor understanding of English
3. Patients with known neurological or psychiatric conditions (other than depression or anxiety) likely to independently affect the results of pain assessment, for example, peripheral diabetic neuropathy in the opinion of the research team.
4. For feasibility study
4.1. Major neuropsychiatric disorder (bipolar disorder, schizophrenia or psychotic spectrum disorders), however, participants with depression and anxiety will be eligible
4.2. Epilepsy
4.3. Cognitive impairment, dementia or neurodegenerative disorder
4.4. Recent or planned surgery
4.5. Current or planned night-time shift work
4.6. Sleep disorders such as sleep apnoea, restless leg syndrome, circadian rhythm disorder, or parasomnia
4.7. Taking prescribed sleep medications on more than 2 nights in past 2 weeks
4.8. Currently receiving other psychological therapy for insomnia
4.9. Pregnant or lactating

Previous participant exclusion criteria:
1. Patients from vulnerable groups
2. Patients with a poor understanding of English
3. Patients with known neurological or psychiatric conditions (other than depression or anxiety) likely to independently affect the results of pain assessment, for example peripheral diabetic neuropathy in the opinion of the research team.

Study & Design

• Study Type: Observational
• Study Design: Not specified