NCT03646084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

August 2, 2021

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

August 17, 2018

Last Update Submit

July 30, 2021

Conditions

Chronic PainSleepCircadian Rhythm Disorders

Keywords

painsleepcircadian rhythm

Outcome Measures

Primary Outcomes (1)

  • Opioid consumed dose

    Quantification of decrease dose opioids consumption related through the management of sleep disorders.

    12 months

Secondary Outcomes (9)

  • Opioids urine drugs test to assess opioids consumption

    12 months

  • Determine inclusion rhythm.

    6 months

  • Number of patients lost in follow up.

    12 months

  • Sleep circadian study's methodology

    12 months

  • Number of patients that complete the SCIP

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Sleep Intervention Program (SCIP)

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Rehabilitation according to current clinical practice.

Other: Rehabilitation program

Interventions

Sleep and Circadian Intervention Program (SCIP) plus rehabilitation programOTHER

To study circadian rhythm disorders and sleep disorders and develops the SCIP to improve sleep in the patients.

Sleep Intervention Program (SCIP)
Rehabilitation programOTHER

Rehabilitation program current clinical practice

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects older than 18 years
  • Patients have no severe reading or learning difficulty
  • Signature of informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

MeSH Terms

Conditions

Chronic PainChronobiology DisordersPain

Interventions

SleepRehabilitation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Olga Mediano

    Consorcio Centro de Investigación Biomédica en Red (CIBER)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 24, 2018

Study Start

October 10, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

August 2, 2021

Record last verified: 2020-01

Locations

ES(1)