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SELF-REGULATION IN STRESS AND CHRONIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL EMPLOYING A VIBRO HRV-TRAINING AND MYOFASCIAL SELF-TREATMENT

Not Applicable
Conditions
M54.5
Low back pain
Registration Number
DRKS00031284
Lead Sponsor
CIT Research Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
28
Inclusion Criteria

Chronic back pain with prominence in the lumbar region for a duration of at least 3 months and a frequency of at least once a week; pain severity on a numerical rating scale (0-10) of at least 5 points; subcutaneous fat layer thickness on lumber area less than 2cm (measured with a skin fold applicator).

Exclusion Criteria

Acute herniated disc; acute local and general inflammations; neurological disorders; fibromyalgia; radicular symptoms with positive Laseque test and foot lifting dysfunction; paraspinal metastases or tumors; cancer diseases requiring chemotherapy, radio-therapy or surgical treatment over the next 12 months; characteristics of rheumatological, cardiovascular or pulmonary chronic diseases; severe depressions and severe anxiety disorders; suicidal tendency; drug abuse or addiction; pregnancy; adiposity; cardiac pacemaker.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
All measurements taken pre intervention, post 3 weeks and post 13 weeks. <br>1. Participant's elasticity and stiffness laterally to the lumbar spine using a MyotonPRO <br>2. Pain sensitivity using Algometer-Indentometer<br>3. Range of motion using Mobee Med<br>4. Respiratory sinus arrhythmia using HRV Scanner Biosign<br><br>
Secondary Outcome Measures
NameTimeMethod
All measurements taken pre intervention, post 3 weeks and post 13 weeks. <br>1. Participant's pain and stress using the brief pain inventory (BPI)<br>2. Pain disability index (PDI)<br>3. Modified stress questionnaire (developed specifically for this study)<br>
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