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Completed

NCT Number: NCT01822236

Craniosacral Therapy to Treat Chronic Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Almeria

Almería, Almeria, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Craniosacral Therapy Program

Other

The ten techniques of craniosacral therapy program are: Still Point (CV-4, Sacred Feet), diaphragms(pelvic, respiratory, thoracic inlet, hyoid, Occipital Cranial Base), Decompression L5-S1, Dural Tube Glide, Lift Front, Parietal Lift, Compression / decompression of the joint sphenobasilar, Temporary Technique, Compression / decompression of the temporomandibular joints, and Still Point CV-4.

One technique of craniosacral therapy

Other

Decompression L5-S1: lumbosacral decompression

Primary outcomes

  1. Change for the Roland Morris Disability Questionnaire

    Time frame: At baseline, 10 weeks and 15 weeks

    The Roland Morris Disability Questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability

Secondary outcomes

  1. Change for the Lifestyle indicators

    Time frame: At baseline, 10 weeks and 15 weeks

    Estimation interstitial fluid biochemistry and measure the following indicators: body mass, hormonal, autonomic nervous system and oxidative stress.

  2. Change on Neural Network Analysis

    Time frame: At baseline, 10 weeks and 15 weeks

    Analysis of the projection on the spine and segmental innervation projection

  3. Change on Quality of Life

    Time frame: At baseline, 10 weeks and 15 weeks

    SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Collaborators

  • Universidad de Granada

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2013
Registry last updated
Mar 25, 2015

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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