Craniosacral Therapy in Patients With Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527252
• Other study ID #: UAL-472
• Status: Completed
• Phase: Phase 0
• First received: August 14, 2015
• Last updated: January 10, 2017
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2017
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Musculoskeletal Manipulations

Intervention

Other:
• Craniosacral therapy

• Classic Massage

Locations

Country	Name	City	State
Spain	Universidad de Almeria	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

Blood SD. The craniosacral mechanism and the temporomandibular joint. J Am Osteopath Assoc. 1986 Aug;86(8):512-9. — View Citation

Castro-Sánchez AM, Matarán-Peñarrocha GA, Sánchez-Labraca N, Quesada-Rubio JM, Granero-Molina J, Moreno-Lorenzo C. A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients. — View Citation

Downey PA, Barbano T, Kapur-Wadhwa R, Sciote JJ, Siegel MI, Mooney MP. Craniosacral therapy: the effects of cranial manipulation on intracranial pressure and cranial bone movement. J Orthop Sports Phys Ther. 2006 Nov;36(11):845-53. — View 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. — View Citation

Green C, Martin CW, Bassett K, Kazanjian A. A systematic review of craniosacral therapy: biological plausibility, assessment reliability and clinical effectiveness. Complement Ther Med. 1999 Dec;7(4):201-7. Review. — View Citation

Matarán-Peñarrocha GA, Castro-Sánchez AM, García GC, Moreno-Lorenzo C, Carreño TP, Zafra MD. Influence of craniosacral therapy on anxiety, depression and quality of life in patients with fibromyalgia. Evid Based Complement Alternat Med. 2011;2011:178769. — View 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. — View Citation

Sutherland WG. The cranial bowl. 1944. J Am Osteopath Assoc. 2000 Sep;100(9):568-73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Hemoglobin Oxygen Saturation	This outcome measure will be assess with Electro Intersticial Scanner	10 weeks and 14 weeks	No
Secondary	Systolic Blood Pressure	This outcome measure will be assess with Electro Intersticial Scanner	10 weeks and 14 weeks	No
Secondary	Diastolic Blood Pressure	This outcome measure will be assess with Electro Intersticial Scanner	10 weeks and 14 weeks	No
Secondary	Hemodynamic (Cardiac Index)	This outcome measure will be assess with Electro Intersticial Scanner	10 weeks and 14 weeks	No
Secondary	Insterticial Liquid Biochemical Estimation	This outcome measure will be assess with Electro Intersticial Scanner	10 weeks and 14 weeks	No