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Low Back PainEarly Phase 1NCT02527252

Craniosacral Therapy in Patients With Chronic Low Back Pain

A Early Phase 1 study testing Craniosacral therapy and Classic Massage in people with Low Back Pain and Musculoskeletal Manipulations, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain, Musculoskeletal Manipulations
What is being tested?
Craniosacral therapy and Classic Massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteSpain
Study dates
Jul 2015to Nov 2015
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad de Almeria

    Almería, Almería, 04120

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Craniosacral therapy, Classic Massage
Keywords
Massage, Craniosacral, Disability Evaluation, Randomized Controlled Trial
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Craniosacral therapyOther

  • Classic MassageOther

Study groups in NCT02527252
Study groupRoleWhat they receive
Craniosacral therapyExperimentalAll 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.
Receives: Other: Craniosacral therapy
Classic MassageActive comparatorClassics massage protocol was compounded by the following techniques of soft tissues massage: effleurage, petrissage, friction, and kneading. The techniques took thirty minutes.
Receives: Other: Classic Massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Changes in 10 weeks and 14 weeks

Secondary outcomes (10)

  1. 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.

    Measured: 10 weeks and 14 weeks

  2. 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.

    Measured: 10 weeks and 14 weeks

  3. 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.

    Measured: 10 weeks and 14 weeks

  4. 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.

    Measured: 10 weeks and 14 weeks

  5. Lumbar mobility in flexion

    Lumbar mobility in flexion was determined by measuring the finger-to-floor distance with a tape.

    Measured: 10 weeks and 14 weeks

  6. Hemoglobin Oxygen Saturation

    This outcome measure will be assess with Electro Intersticial Scanner

    Measured: 10 weeks and 14 weeks

  7. Systolic Blood Pressure

    This outcome measure will be assess with Electro Intersticial Scanner

    Measured: 10 weeks and 14 weeks

  8. Diastolic Blood Pressure

    This outcome measure will be assess with Electro Intersticial Scanner

    Measured: 10 weeks and 14 weeks

  9. Hemodynamic (Cardiac Index)

    This outcome measure will be assess with Electro Intersticial Scanner

    Measured: 10 weeks and 14 weeks

  10. Insterticial Liquid Biochemical Estimation

    This outcome measure will be assess with Electro Intersticial Scanner

    Measured: 10 weeks and 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionOct 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02527252
Sponsor's protocol ID
UAL-472
Status last verified
Jan 2017
First submitted
14 Aug 2015
Last updated
11 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10709302

  • 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.

    PubMed 17154138

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

    PubMed 11057075

  • 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.

    PubMed 20702514

  • 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.

    PubMed 19729492

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

    PubMed 3759521

  • 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.

    PubMed 23337558

  • 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.

    PubMed 18215746

  • 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.

    PubMed 18350746

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Craniosacral therapy and Classic Massage in people with Low Back Pain and Musculoskeletal Manipulations, run by Universidad de Almeria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Roland-Morris Disability Questionnaire (RMQ) (time frame: Changes in 10 weeks and 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02527252, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.

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