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Sleep and Circadian Intervention Program for Chronic Musculoskeletal Pain

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ClinicalTrials.gov Identifier: NCT03646084
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
Hospital General Universitario de 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
Information provided by (Responsible Party):
OlgaMediano, Consorcio Centro de Investigación Biomédica en Red, M.P.

Brief Summary:

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 informed consent, a medical history, physical exam, evaluation of the pain perception (EQ5D5L), quality of life evaluation (SF36 and FOSQ), mood and anxiety (HADS y PASS20), circadian rhythm study and drugs consumption will be evaluated in both groups. Patients will be randomized to control group (usual rehabilitation program) or intervention group (usual rehabilitation program + sleep circadian intervention program-SCIP). The patient in the SCIP program will received the next intervention: 1) Educational and circadian rhythm intervention: general sleep hygiene recommendation and promotion of daily physical activity. 2) Sleep studies for sleep quality and sleep disorders diagnosis: full polysomnography 3) Sleep questionnaires for another sleep disorders. Based on the results of the studies, patients will be treated according to current guidelines for the management of sleep disorders. 6 month after the SCIP starts patients will be evaluated in the End of Study Visit (EOS) as in the BV and also in their functional improvement and health resources consumption.


Condition or disease Intervention/treatment Phase
Chronic Pain Sleep Circadian Rhythm Disorders Other: Sleep and Circadian Intervention Program (SCIP) plus rehabilitation program Other: Rehabilitation program Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of a Sleep and Circadian Intervention Program (SCIP) in Chronic Musculoskeletal Pain (CMP) Rehabilitation: a Feasibility PILOT Study
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Sleep Intervention Program (SCIP)
Based on the results of the studies, patients will be treated according to current guidelines: 1) Improve rest/activity rhythms. 2) To treat and control Sleep Disorder Breathing. 3) To improve anxiety, depression and insomnia. 4) To treat RLS if needed. 5) To try opioid dose reduction. 6) To trial of non-opioid in lieu of opioids. 7) Avoiding use of benzodiazepines, sedatives, hypnotics. 8) Caution against alcohol use.
Other: Sleep and Circadian Intervention Program (SCIP) plus rehabilitation program
To study circadian rhythm disorders and sleep disorders and develops the SCIP to improve sleep in the patients.

Active Comparator: Control
Rehabilitation according to current clinical practice.
Other: Rehabilitation program
Rehabilitation program current clinical practice




Primary Outcome Measures :
  1. Opioid consumed dose [ Time Frame: 12 months ]
    Quantification of decrease dose opioids consumption related through the management of sleep disorders.


Secondary Outcome Measures :
  1. Opioids urine drugs test to assess opioids consumption [ Time Frame: 12 months ]
    Quantification of decrease in number of patients with opioids consumption (urine levels) through the management of sleep disorders.

  2. Determine inclusion rhythm. [ Time Frame: 6 months ]
    To determine the patient inclusion rhythm (recruitment rate) and, if necessary, the reasons for non-recruitment.

  3. Number of patients lost in follow up. [ Time Frame: 12 months ]
    To determine the follow-up rate.

  4. Sleep circadian study's methodology [ Time Frame: 12 months ]
    To test the sleep circadian study's methodology in this type of population.

  5. Number of patients that complete the SCIP [ Time Frame: 12 months ]
    To assess the acceptability, implementation and preliminary efficacy of the SCIP.

  6. Number of patients the developed the EOS visit [ Time Frame: 12 months ]
    To evaluate adherence and fidelity to the SCIP through recruitment and retention.

  7. Determine data acquisition. [ Time Frame: 18 months ]
    To determine the data acquisition rate, amount of missing data and reasons for loss.

  8. Number of participants with SCIP-related adverse events as assessed [ Time Frame: 12 months ]
    To evaluate the safety of the program.

  9. Number of patients needed related to the SCIP effect size. [ Time Frame: 12 months ]
    To characterize the effect observed in our intervention in order to properly calculate the sample size necessary for the main study. Data from key outcome measures were later used to determine the sample size for a definitive trial.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646084


Contacts
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Contact: Olga Mediano, MD +34 678634778 olgamediano@hotmail.com

Locations
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Spain
Hospital Universitario de Guadalajara Recruiting
Guadalajara, Spain, 19002
Contact: Olga Mediano         
Sponsors and Collaborators
Consorcio Centro de Investigación Biomédica en Red, M.P.
Hospital General Universitario de 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
Investigators
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Principal Investigator: Olga Mediano Consorcio Centro de Investigación Biomédica en Red, M.P.

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Responsible Party: OlgaMediano, Principal Investigator, Consorcio Centro de Investigación Biomédica en Red, M.P.
ClinicalTrials.gov Identifier: NCT03646084     History of Changes
Other Study ID Numbers: CIBERES-FES2018-05
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by OlgaMediano, Consorcio Centro de Investigación Biomédica en Red, M.P.:
pain
sleep
circadian rhythm

Additional relevant MeSH terms:
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Musculoskeletal Pain
Chronobiology Disorders
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases