Clinical trial NCT01822236: Craniosacral Therapy to Treat Chronic Low Back Pain
Official title: Effectiveness of a Craniosacral Therapy Program on Disability, Quality of Life, Autonomic Nervous System and Oxidative Stress Indicators in Chronic Low Back Pain: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
Manual Therapy
Randomized Controlled Trial
Quality of life
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
First posted: 2013-04-02
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a craniosacral therapy program are effective on disability, quality of life, autonomic nervous system and oxidative stress indicators in patients with chronic low back pain.

Detailed description: Design: Randomized clinical trial. Objective: to determine the effectiveness of a craniosacral therapy program on disability, quality of life, autonomic nervous system, body mass, hormonal indicators, spinal projection, and oxidative stress indicators in patients with chronic low back pain.

Participants: Seventy patients with chronic non-specific low back pain will be randomly assigned to an experimental and control group.

Intervention: For 10-week, the experimental group will undergo treatment comprising 10 sessions (1/week) of a craniosacral therapy program with ten techniques, and the control group will receive only one craniosacral technique.

Main Outcome Measures: disability, quality of life, biochemical estimation interstitial fluid, body mass indicators, hormonal indicators, indicators of autonomic nervous system,and indicators of oxidative stress will be collected in both groups at baseline, 10 weeks and 15 weeks after the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with an independent Student t-test for continuous data. Separate 2x3 model ANOVA with time (baseline, 10 weeks and 15 weeks) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment.

Eligibility criteria: Inclusion Criteria:

* Low back pain for \> 3 months
* Score \> 4 on the Roland Morris Disability questionnaire
* No undergoing another physical therapy treatment

Exclusion Criteria:

* Clinical signs of radiculopathy
* Presence of lumbar stenosis
* Fibromyalgia
* Spondylolisthesis
* History of spinal surgery
* Treatment with corticosteroids in the past two weeks
* Disease of the central or peripheral nervous system

Primary outcomes:
measure: Change for the Roland Morris Disability Questionnaire
timeFrame: At baseline, 10 weeks and 15 weeks
Secondary outcomes:
measure: Change for the Lifestyle indicators
timeFrame: At baseline, 10 weeks and 15 weeks
measure: Change on Neural Network Analysis
timeFrame: At baseline, 10 weeks and 15 weeks
measure: Change on Quality of Life
timeFrame: At baseline, 10 weeks and 15 weeks
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Universidad de Almeria
Study officials:
affiliation: Universidad de Almeria
name: Adelaida Castro-Sánchez, PhD
role: STUDY_DIRECTOR
References:
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