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Sleep and Circadian Intervention Program for Chronic Musculoskeletal Pain

CompletedNot applicableNCT03646084
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Musculoskeletal pain has become in a major problem related to its prevalence, treatment cost, absenteeism, quality of life impairment, disability and drugs consumption. The difficulty in musculoskeletal pain control ends in the abuse of drugs by these patients, including opioids. This drugs consumption has become a health problem in the United States and around the world related to their increasing abuse mainly between 2002 and 2011 and has had an impact in the numbers of deaths caused by opioids prescription (reaching 16,651 deaths in United States in 2010). Pain is clearly associated with sleep disturbances (50-80% of these patients suffer from a sleep problem), and in turn poor sleep quality leads to increased pain sensitivity. There is evidence showing that improving sleep disturbance co-occurring pain would improve, and some may reduce the use of opioids in specific patients on long-term opioid therapy. In spite of this reciprocal relationship between sleep and pain only few programs take into account the management of sleep disorders as a non-pharmacological measure for pain control. The hypothesis is: "to address sleep and circadian disorders (SCD) using a Sleep and Circadian Intervention Program (SCIP) in patients treated with rehabilitation by chronic musculoskeletal pain (CMP) optimizes the rehabilitation outcomes and reduces opioids consumption". Main goal: The aim of this PILOT study is to evaluate the feasibility of the protocol of the present study that aims to assess the improvement in rehabilitation outcomes and decrease in opioid consumption, through the management of sleep disorders. Methodology Using a randomised (1:1) controlled feasibility study, 50 men and women will be included to evaluate methodology and identify the potential outcome of the main project. Subjects older than 18 years included in a rehabilitation program by musculoskeletal lumbar pain lasting more than three months will be recruited. Basal Visit (BV): After the signature of in…

Study details

Official title
The Impact of a Sleep and Circadian Intervention Program (SCIP) in Chronic Musculoskeletal Pain (CMP) Rehabilitation: a Feasibility PILOT Study
Conditions
Interventions
  • Other: Sleep and Circadian Intervention Program (SCIP) plus rehabilitation program
  • Other: Rehabilitation program
Sponsor
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Collaborators
University of Guadalajara; Hospital Universitario La Paz; Fundación para la Formación y la Investigación de los Profesionales de la Salud- Cáceres (FUNDESALUD); Instituto de Investigación Biomédica de Lleida; Hospital Clinic of Barcelona
Start date
2018-10-10
Primary completion
2020-02-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Spain
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subjects older than 18 years * Inclusion in a rehabilitation program by lumbar musculoskeletal pain lasting more than three months * Patients have no severe reading or learning difficulty * Signature of informed consent. Exclusion Criteria: * Severe psychopathological co-morbidity (e.g. the presence of schizophrenia, bipolar disorders…) * Co-morbid malignant/terminal diseases (e.g. HIV/AIDS, cancer) * Shift-workers and people who work making transmeridian travels.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03646084