Craniosacral Therapy to Treat Chronic Low Back Pain

Universidad de Almeria

Status: Completed

Conditions: Low Back Pain

Treatments: Other: One technique of craniosacral therapy; Other: Craniosacral Therapy Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01822236

UAL-123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Craniosacral Therapy Program

Experimental group

Description:

A program of 10 craniosacral therapy techniques

Treatment:

Other: Craniosacral Therapy Program

One technique of craniosacral therapy

Active Comparator group

Description:

Decompression L5-S1.

Treatment:

Other: One technique of craniosacral therapy