Craniosacral Therapy in Patients With Chronic Low Back Pain

Study Overview
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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.

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.

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

Conditions
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Low Back Pain, Musculoskeletal Manipulations

Intervention / Treatment
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* Other: Craniosacral therapy
* Other: Classic Massage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Craniosacral therapy<br>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<br> <br> |
| Active Comparator: Classic Massage<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris Disability Questionnaire (RMQ) | 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). | 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 | 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) | 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 | 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 | Lumbar mobility in flexion was determined by measuring the finger-to-floor distance with a tape. | 10 weeks and 14 weeks | 
| Hemoglobin Oxygen Saturation | This outcome measure will be assess with Electro Intersticial Scanner | 10 weeks and 14 weeks | 
| Systolic Blood Pressure | This outcome measure will be assess with Electro Intersticial Scanner | 10 weeks and 14 weeks | 
| Diastolic Blood Pressure | This outcome measure will be assess with Electro Intersticial Scanner | 10 weeks and 14 weeks | 
| Hemodynamic (Cardiac Index) | This outcome measure will be assess with Electro Intersticial Scanner | 10 weeks and 14 weeks | 
| Insterticial Liquid Biochemical Estimation | This outcome measure will be assess with Electro Intersticial Scanner | 10 weeks and 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, Craniosacral, Disability Evaluation, Randomized Controlled Trial