Low Back Pain, Musculoskeletal Manipulations
Conditions
Keywords
Massage, Craniosacral, Disability Evaluation, Randomized Controlled Trial
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.
Interventions
OTHERCraniosacral therapy
OTHERClassic Massage
Sponsors
Universidad de Almeria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris Disability Questionnaire (RMQ) | Changes in 10 weeks and 14 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| 10-point Numerical Pain Rating Scale | 10 weeks and 14 weeks | 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) | 10 weeks and 14 weeks | 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 | 10 weeks and 14 weeks | 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 | 10 weeks and 14 weeks | Lumbar mobility in flexion was determined by measuring the finger-to-floor distance with a tape. |
| Oswestry Low Back Pain Disability Index (ODI). | 10 weeks and 14 weeks | 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. |
| Systolic Blood Pressure | 10 weeks and 14 weeks | This outcome measure will be assess with Electro Intersticial Scanner |
| Diastolic Blood Pressure | 10 weeks and 14 weeks | This outcome measure will be assess with Electro Intersticial Scanner |
| Hemodynamic (Cardiac Index) | 10 weeks and 14 weeks | This outcome measure will be assess with Electro Intersticial Scanner |
| Insterticial Liquid Biochemical Estimation | 10 weeks and 14 weeks | This outcome measure will be assess with Electro Intersticial Scanner |
| Hemoglobin Oxygen Saturation | 10 weeks and 14 weeks | This outcome measure will be assess with Electro Intersticial Scanner |
Countries
Spain
Outcome results
None listed