Sleep and Circadian Intervention Program for Chronic Musculoskeletal Pain

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.

Conditions

• Chronic Pain
• Sleep
• Circadian Rhythm Disorders

Interventions

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.

OTHER

Rehabilitation program

Rehabilitation program current clinical practice

Sponsors & Collaborators

• Hospital General Universitario de Guadalajara

  collaborator UNKNOWN

• Hospital Universitario La Paz

  collaborator OTHER

• Fundación para la Formación y la Investigación de los Profesionales de la Salud- Cáceres (FUNDESALUD)

  collaborator UNKNOWN

• Instituto de Investigación Biomédica de Lleida

  collaborator UNKNOWN

• Hospital Clinic of Barcelona

  collaborator OTHER

• Consorcio Centro de Investigación Biomédica en Red (CIBER)

  lead OTHER_GOV

Principal Investigators

• Olga Mediano · Consorcio Centro de Investigación Biomédica en Red (CIBER)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-10

Primary Completion

2020-02-01

Completion

2020-02-01

Countries

• Spain

Study Locations