Low Back Pain Clinical Trial
Official title:
Benefits of Craniosacral Therapy in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
Verified date | January 2017 |
Source | Universidad de Almeria |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de Almeria | Almería |
Lead Sponsor | Collaborator |
---|---|
Universidad de Almeria |
Spain,
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
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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 |
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