Craniosacral Therapy in Patients With Chronic Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-11-30

Brief Summary

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The purpose of the current randomized clinical trial was to analyze the effectiveness of craniosacral therapy on disability, pain intensity, kinesiophobia, quality of life, isometric endurance of trunk flexor muscles, mobility, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid in individuals with chronic low back pain.

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Detailed Description

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Objective: To analyze the effects of craniosacral therapy on disability, pain intensity, quality of life, and mobility in patients with chronic low back pain.

Design: A single blinded randomized controlled trial. Setting: Clinical setting. Subjects: Sixty-four patients (42 females) with chronic low back pain. Interventions: Patients were randomly assigned to an experimental group (craniosacral therapy group) or a control group (classic massage group).

Main measures: Self-reported disability (Roland Morris Disability Questionnaire - primary outcome; and Oswestry Disability Index), pain intensity (a 10-point Numerical Pain Rating Scale), scale of kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade Test), lumbar mobility in flexion, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid.

Conditions

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Low Back Pain Musculoskeletal Manipulations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Craniosacral therapy

All treatments were applied by two experienced therapists with a 10-year certification in manipulative therapy after completion of their physical therapy degree and more than 20 years of clinical experience with patients. All patients received the intervention on the day of their initial examination. The techniques took 50 minutes and were conducted as follows:

* Pelvic Diaphragm Release.
* Respiratory Diaphragm Release.
* Thoracic Inlet Release.
* Hyoid release.
* Sacral technique for stabilize L5/sacrum.
* CV-4 Still Point Induction.

Group Type EXPERIMENTAL

Craniosacral therapy

Intervention Type OTHER

Classic Massage

Classics massage protocol was compounded by the following techniques of soft tissues massage: effleurage, petrissage, friction, and kneading. The techniques took thirty minutes.

Group Type ACTIVE_COMPARATOR

Classic Massage

Intervention Type OTHER

Interventions

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Craniosacral therapy

Intervention Type OTHER

Classic Massage

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. LBP for/over three months.
2. age between 18 and 65 years.
3. score equal or superior of four points on the Roland Morris Disability Questionnaire.
4. not currently receiving physical therapy.

Exclusion Criteria

1. presence of lumbar stenosis
2. diagnosis of spondylolisthesis
3. diagnosis of fibromyalgia
4. treatment with corticosteroid or oral medication within the past two weeks
5. a history of spinal surgery
6. disease of the central or peripheral nervous system

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No