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Completed

NCT Number: NCT02527252

Craniosacral Therapy in Patients With Chronic Low Back Pain

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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Universidad de Almeria

Almería, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • presence of lumbar stenosis
  • diagnosis of spondylolisthesis
  • diagnosis of fibromyalgia
  • treatment with corticosteroid or oral medication within the past two weeks
  • a history of spinal surgery
  • disease of the central or peripheral nervous system

Treatment and study plan

Craniosacral therapy

Other

classic massage

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Hemoglobin Oxygen Saturation

    Time frame: 10 weeks and 14 weeks

    This outcome measure will be assess with Electro Intersticial Scanner

  7. Systolic Blood Pressure

    Time frame: 10 weeks and 14 weeks

    This outcome measure will be assess with Electro Intersticial Scanner

  8. Diastolic Blood Pressure

    Time frame: 10 weeks and 14 weeks

    This outcome measure will be assess with Electro Intersticial Scanner

  9. Hemodynamic (Cardiac Index)

    Time frame: 10 weeks and 14 weeks

    This outcome measure will be assess with Electro Intersticial Scanner

  10. Insterticial Liquid Biochemical Estimation

    Time frame: 10 weeks and 14 weeks

    This outcome measure will be assess with Electro Intersticial Scanner

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2015
Registry last updated
Jan 11, 2017

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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