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Craniosacral Therapy in Patients With Chronic Low Back Pain

Primary Purpose

Low Back Pain, Musculoskeletal Manipulations

Status
Completed
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Craniosacral therapy
Classic Massage
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Massage, Craniosacral, Disability Evaluation, Randomized Controlled Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad de Almeria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Craniosacral therapy

Classic Massage

Arm Description

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.

Classics massage protocol was compounded by the following techniques of soft tissues massage: effleurage, petrissage, friction, and kneading. The techniques took thirty minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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-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.
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.
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.
Lumbar mobility in flexion
Lumbar mobility in flexion was determined by measuring the finger-to-floor distance with a tape.
Hemoglobin Oxygen Saturation
This outcome measure will be assess with Electro Intersticial Scanner
Systolic Blood Pressure
This outcome measure will be assess with Electro Intersticial Scanner
Diastolic Blood Pressure
This outcome measure will be assess with Electro Intersticial Scanner
Hemodynamic (Cardiac Index)
This outcome measure will be assess with Electro Intersticial Scanner
Insterticial Liquid Biochemical Estimation
This outcome measure will be assess with Electro Intersticial Scanner

Full Information

First Posted
August 14, 2015
Last Updated
January 10, 2017
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT02527252
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Musculoskeletal Manipulations
Keywords
Massage, Craniosacral, Disability Evaluation, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Craniosacral therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Classic Massage
Arm Type
Active Comparator
Arm Description
Classics massage protocol was compounded by the following techniques of soft tissues massage: effleurage, petrissage, friction, and kneading. The techniques took thirty minutes.
Intervention Type
Other
Intervention Name(s)
Craniosacral therapy
Intervention Type
Other
Intervention Name(s)
Classic Massage
Primary Outcome Measure Information:
Title
Roland-Morris Disability Questionnaire (RMQ)
Description
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.
Time Frame
Changes in 10 weeks and 14 weeks
Secondary Outcome Measure Information:
Title
Oswestry Low Back Pain Disability Index (ODI).
Description
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.
Time Frame
10 weeks and 14 weeks
Title
10-point Numerical Pain Rating Scale
Description
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.
Time Frame
10 weeks and 14 weeks
Title
Tampa Scale of Kinesiophobia (TSK)
Description
The Tampa Scale of Kinesiophobia (TSK) is a 17-item questionnaire developed to measure the fear of movement and (re)injury.
Time Frame
10 weeks and 14 weeks
Title
Isometric endurance of trunk flexor muscles
Description
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.
Time Frame
10 weeks and 14 weeks
Title
Lumbar mobility in flexion
Description
Lumbar mobility in flexion was determined by measuring the finger-to-floor distance with a tape.
Time Frame
10 weeks and 14 weeks
Title
Hemoglobin Oxygen Saturation
Description
This outcome measure will be assess with Electro Intersticial Scanner
Time Frame
10 weeks and 14 weeks
Title
Systolic Blood Pressure
Description
This outcome measure will be assess with Electro Intersticial Scanner
Time Frame
10 weeks and 14 weeks
Title
Diastolic Blood Pressure
Description
This outcome measure will be assess with Electro Intersticial Scanner
Time Frame
10 weeks and 14 weeks
Title
Hemodynamic (Cardiac Index)
Description
This outcome measure will be assess with Electro Intersticial Scanner
Time Frame
10 weeks and 14 weeks
Title
Insterticial Liquid Biochemical Estimation
Description
This outcome measure will be assess with Electro Intersticial Scanner
Time Frame
10 weeks and 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universidad de Almeria
City
Almería
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
10709302
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. doi: 10.1016/s0965-2299(99)80002-8.
Results Reference
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PubMed Identifier
17154138
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. doi: 10.2519/jospt.2006.36.11.845.
Results Reference
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PubMed Identifier
11057075
Citation
Sutherland WG. The cranial bowl. 1944. J Am Osteopath Assoc. 2000 Sep;100(9):568-73. No abstract available.
Results Reference
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PubMed Identifier
20702514
Citation
Castro-Sanchez AM, Mataran-Penarrocha GA, Sanchez-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. Clin Rehabil. 2011 Jan;25(1):25-35. doi: 10.1177/0269215510375909. Epub 2010 Aug 11.
Results Reference
result
PubMed Identifier
19729492
Citation
Mataran-Penarrocha GA, Castro-Sanchez AM, Garcia GC, Moreno-Lorenzo C, Carreno 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. doi: 10.1093/ecam/nep125. Epub 2011 Jun 15.
Results Reference
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PubMed Identifier
3759521
Citation
Blood SD. The craniosacral mechanism and the temporomandibular joint. J Am Osteopath Assoc. 1986 Aug;86(8):512-9. No abstract available.
Results Reference
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PubMed Identifier
23337558
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.
Results Reference
result
PubMed Identifier
18215746
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.
Results Reference
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PubMed Identifier
18350746
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.
Results Reference
result

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Craniosacral Therapy in Patients With Chronic Low Back Pain

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