Craniosacral Therapy in Patients With Chronic Low Back Pain

January 10, 2017 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

Benefits of Craniosacral Therapy in Patients With Chronic Low Back Pain: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Universidad de Almería

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Craniosacral therapy
Active Comparator: 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.
Other: Classic Massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roland-Morris Disability Questionnaire (RMQ)
Time Frame: Changes in 10 weeks and 14 weeks
It is one of the most used questionnaires for assessing disability due to LBP. This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to LBP including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
Changes in 10 weeks and 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Low Back Pain Disability Index (ODI).
Time Frame: 10 weeks and 14 weeks
The ODI has 10 items referring to activities of daily living that might be disrupted by LBP. Each item is answered on a 6-point Likert scale ranging from "no problem at all" [0] to "not possible" [5]. The total score ranges from 0 to 50.
10 weeks and 14 weeks
10-point Numerical Pain Rating Scale
Time Frame: 10 weeks and 14 weeks
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) was used to assess the patients' current level of pain, and the worst and lowest level of pain experienced in the preceding 24 hours.
10 weeks and 14 weeks
Tampa Scale of Kinesiophobia (TSK)
Time Frame: 10 weeks and 14 weeks
The Tampa Scale of Kinesiophobia (TSK) is a 17-item questionnaire developed to measure the fear of movement and (re)injury.
10 weeks and 14 weeks
Isometric endurance of trunk flexor muscles
Time Frame: 10 weeks and 14 weeks
To test isometric endurance of trunk flexor muscles we used the McQuade test. Subjects were supine with their arms crossed over the chest, hands on the opposite shoulders, hips bent, and knees and feet apart. They were asked to nod and continue to lift their head and shoulders until the inferior angle of the scapula lifted from the table and maintain the position as long as possible.
10 weeks and 14 weeks
Lumbar mobility in flexion
Time Frame: 10 weeks and 14 weeks
Lumbar mobility in flexion was determined by measuring the finger-to-floor distance with a tape.
10 weeks and 14 weeks
Hemoglobin Oxygen Saturation
Time Frame: 10 weeks and 14 weeks
This outcome measure will be assess with Electro Intersticial Scanner
10 weeks and 14 weeks
Systolic Blood Pressure
Time Frame: 10 weeks and 14 weeks
This outcome measure will be assess with Electro Intersticial Scanner
10 weeks and 14 weeks
Diastolic Blood Pressure
Time Frame: 10 weeks and 14 weeks
This outcome measure will be assess with Electro Intersticial Scanner
10 weeks and 14 weeks
Hemodynamic (Cardiac Index)
Time Frame: 10 weeks and 14 weeks
This outcome measure will be assess with Electro Intersticial Scanner
10 weeks and 14 weeks
Insterticial Liquid Biochemical Estimation
Time Frame: 10 weeks and 14 weeks
This outcome measure will be assess with Electro Intersticial Scanner
10 weeks and 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAL-472

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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