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Craniosacral Therapy in Patients With Chronic Low Back Pain

U

Universidad de Almeria

Status and phase

Completed
Early Phase 1

Conditions

Musculoskeletal Manipulations
Low Back Pain

Treatments

Other: Classic Massage
Other: Craniosacral therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02527252
UAL-472

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Craniosacral therapy
Experimental group
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.
Treatment:
Other: Craniosacral therapy
Classic Massage
Active Comparator group
Description:
Classics massage protocol was compounded by the following techniques of soft tissues massage: effleurage, petrissage, friction, and kneading. The techniques took thirty minutes.
Treatment:
Other: Classic Massage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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