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Completed

NCT Number: NCT01648738

Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration

The purpose of this study is to determine whether an intensive 5 days long multidisciplinary program (including spa therapy, exercises and patients'education) is more effective regarding return to work than usual care in subacute and chronic low back pain for people in sick leave from 4 to 24 weeks duration, and for which an extension of sick leave is considered

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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochin Hospital

Paris, 75014, France

About this study

Sick leave due to low back pain (LBP) is costly and compromises workforce productivity. Sick leave itself, fears and believes regarding return to work, and a low self-esteem have been identified as independent predictors of extended sick leave. Previous data suggested that multidisciplinary rehabilitation programs, including physical activities and psychobehavioral management, should decrease sick leave duration in chronic LBP. However these programs are heavy (at least 4 weeks long), and are often proposed to patients at the end of the management (over 6 months after the beginning of symptoms). Another approach could be to propose a shorter multidisciplinary program (for example 5 days long), earlier in the history of LBP to break the vicious circle as soon as possible. The target population could be people suffering from subacute LBP with sick leave duration between 4 and 24 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged from 18 to 60 years (included)
  • Low back pain (or back and radicular pain with back pain the most painful)
  • Sick leave between 4 and 24 weeks duration, without expected return to work
  • A prior medical evaluation is made and the results will be communicated to the patient
  • Patient giving his informed consent to participate in the study
  • Patient affiliated to or beneficiary of social insurance

Exclusion criteria

  • Cognition or behavioral disorders making it impossible to assess
  • Inability to speak and write French
  • Contra-indication to perform a short spa therapy

Treatment and study plan

Spa therapy, exercise and educational therapy

Other

During 5 days: Spa therapy (2 hours/day), exercises (30 min/day), educational therapy (45 min/day) including education on physical activities, work, and pain management

Other names: multidisciplinary program

Usual Care

Other

Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book

Primary outcomes

  1. Frequency of return to work

    Time frame: 1 year

    Frequency of return to work 1 year after the inclusion date

Secondary outcomes

  1. Pain

    Time frame: Every 2 weeks during 1 year

    Evaluated by the area under the curve of pain (numeric scale from 0 to 100) assessed every 2 weeks during 1 year

  2. Function

    Time frame: 1 year

    Assessed with QUEBEC functional scale

  3. Quality of life

    Time frame: 1 year

    Assessed with MOS SF- 12

  4. TWIST

    Time frame: 1 year

    Time without symptom (without pain)

  5. Sick leave

    Time frame: 1 year

    Number of sick leave days from 6 to 12 months after inclusion date

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Association Francaise pour la Recherche Thermale

Registry information

Official study title

Effectiveness of a Short, Intensive and Standardised Spa Therapy for Subacute and Chronic Low Back Pain on Return to Work for Patients in Sick Leave From 4 to 24 Weeks Duration : a Randomized Controlled Trial Using a Modified Zelen Method

Acronym: ITILO

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 24, 2012
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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