Craniosacral Therapy in Patients With Chronic Low Back Pain

Early Phase 1

Completed

• Conditions: Low Back Pain; Musculoskeletal Manipulations
• Interventions: Other: Craniosacral therapy; Other: Classic Massage

• Registration Number: NCT02527252
• Lead Sponsor: Universidad de Almeria

Brief Summary

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

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Craniosacral therapy	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.
Classic Massage	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.

Primary Outcome Measures

Name	Time	Method
Roland-Morris Disability Questionnaire (RMQ)	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 Outcome Measures

Name	Time	Method
Oswestry Low Back Pain Disability Index (ODI).	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-point Numerical Pain Rating Scale	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.
Tampa Scale of Kinesiophobia (TSK)	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.
Isometric endurance of trunk flexor muscles	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.
Lumbar mobility in flexion	10 weeks and 14 weeks	Lumbar mobility in flexion was determined by measuring the finger-to-floor distance with a tape.
Hemoglobin Oxygen Saturation	10 weeks and 14 weeks	This outcome measure will be assess with Electro Intersticial Scanner
Systolic Blood Pressure	10 weeks and 14 weeks	This outcome measure will be assess with Electro Intersticial Scanner
Diastolic Blood Pressure	10 weeks and 14 weeks	This outcome measure will be assess with Electro Intersticial Scanner
Hemodynamic (Cardiac Index)	10 weeks and 14 weeks	This outcome measure will be assess with Electro Intersticial Scanner
Insterticial Liquid Biochemical Estimation	10 weeks and 14 weeks	This outcome measure will be assess with Electro Intersticial Scanner

Trial Locations

Locations (1)

Universidad de Almeria; 🇪🇸 Almería, Spain