NCT02527252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2015

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

August 14, 2015

Last Update Submit

January 10, 2017

Conditions

Low Back PainMusculoskeletal Manipulations

Keywords

MassageCraniosacralDisability EvaluationRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • Oswestry Low Back Pain Disability Index (ODI).

    10 weeks and 14 weeks

  • 10-point Numerical Pain Rating Scale

    10 weeks and 14 weeks

  • Tampa Scale of Kinesiophobia (TSK)

    10 weeks and 14 weeks

  • Isometric endurance of trunk flexor muscles

    10 weeks and 14 weeks

  • Lumbar mobility in flexion

    10 weeks and 14 weeks

  • +5 more secondary outcomes

Study Arms (2)

Craniosacral therapy

EXPERIMENTAL

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.

Other: Craniosacral therapy

Classic Massage

ACTIVE COMPARATOR

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

Other: Classic Massage

Interventions

Craniosacral therapyOTHER
Craniosacral therapy
Classic MassageOTHER
Classic Massage

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Almeria

Almería, Almería, 04120, Spain

Location

Related Publications (9)

  • 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.

    PMID: 10709302RESULT

  • 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.

    PMID: 17154138RESULT

  • Sutherland WG. The cranial bowl. 1944. J Am Osteopath Assoc. 2000 Sep;100(9):568-73. No abstract available.

    PMID: 11057075RESULT

  • 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.

    PMID: 20702514RESULT

  • 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.

    PMID: 19729492RESULT

  • Blood SD. The craniosacral mechanism and the temporomandibular joint. J Am Osteopath Assoc. 1986 Aug;86(8):512-9. No abstract available.

    PMID: 3759521RESULT

  • 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.

    PMID: 23337558RESULT

  • 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.

    PMID: 18215746RESULT

  • 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.

    PMID: 18350746RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 18, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

ES(1)