Clinical trial NCT02527252: Craniosacral Therapy in Patients With Chronic Low Back Pain
Official title: Benefits of Craniosacral Therapy in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Low Back Pain
Musculoskeletal Manipulations
Keywords: Massage
Craniosacral
Disability Evaluation
Randomized Controlled Trial
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Roland-Morris Disability Questionnaire (RMQ)
timeFrame: Changes in 10 weeks and 14 weeks
Secondary outcomes:
measure: Oswestry Low Back Pain Disability Index (ODI).
timeFrame: 10 weeks and 14 weeks
measure: 10-point Numerical Pain Rating Scale
timeFrame: 10 weeks and 14 weeks
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 10 weeks and 14 weeks
measure: Isometric endurance of trunk flexor muscles
timeFrame: 10 weeks and 14 weeks
measure: Lumbar mobility in flexion
timeFrame: 10 weeks and 14 weeks
measure: Hemoglobin Oxygen Saturation
timeFrame: 10 weeks and 14 weeks
measure: Systolic Blood Pressure
timeFrame: 10 weeks and 14 weeks
measure: Diastolic Blood Pressure
timeFrame: 10 weeks and 14 weeks
measure: Hemodynamic (Cardiac Index)
timeFrame: 10 weeks and 14 weeks
measure: Insterticial Liquid Biochemical Estimation
timeFrame: 10 weeks and 14 weeks
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almeria
Study officials:
References:
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citation: Arnadottir TS, Sigurdardottir AK. Is craniosacral therapy effective for migraine? Tested with HIT-6 Questionnaire. Complement Ther Clin Pract. 2013 Feb;19(1):11-4. doi: 10.1016/j.ctcp.2012.09.003. Epub 2012 Nov 9.
citation: Nourbakhsh MR, Fearon FJ. The effect of oscillating-energy manual therapy on lateral epicondylitis: a randomized, placebo-control, double-blinded study. J Hand Ther. 2008 Jan-Mar;21(1):4-13; quiz 14. doi: 10.1197/j.jht.2007.09.005.
citation: Gerdner LA, Hart LK, Zimmerman MB. Craniosacral still point technique: exploring its effects in individuals with dementia. J Gerontol Nurs. 2008 Mar;34(3):36-45. doi: 10.3928/00989134-20080301-04.