The Effect of Myofascial Induction and Therapeutic Pain Education in Chronic Low Back Pain
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of this study was to investigate the effects of therapeutic pain education and myofascial induction therapy on pain and function in patients with chronic low back pain. In the literature, studies on myofascial induction therapy in patients with chronic low back pain are very limited and there is no study comparing therapeutic pain training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedStudy Start
First participant enrolled
November 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2020
CompletedFebruary 20, 2020
February 1, 2020
10 months
September 21, 2018
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
Mc Gill pain survey
The McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. Seven words are selected from the following categories: dimension 1 to 10 (pain descriptors), three words; dimensions 11 to 15 (affective components of pain), dimension 16 (evaluation of pain) one word, and dimension 17 to 20 (miscellaneous) one word. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain). Qualitative differences in pain may be reflected in respondent's word choice
8 week
Roland Morris Disability index
Roland-Morris Disability Questionnaire\[1\] is designed to assess self-rated physical disability caused by low back pain. There are different questionnaires available, which differ from each other in the number of statements: 24-, 18- and 11-item questionnaire. The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 11, 18 or 24 (max. disability) depending on the questionnaire that is used.
8 week
Survey of fear avoidance beliefs
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96.
8 week
Evaluation of mobility (finger ground test)
fingertip-to-floor (FTF) test as an outcome measure on the great majority of my patients presenting with lumbo-pelvic pain, for the simple reason that forward bending is one of the more painful and limited movements, especially in those with neural symptoms. The FTF test has been shown to have excellent reliability without the use of standardized instructions and patient positioning. It must be stated that the FTF test has been criticized for not measuring isolated lumbar flexion range of motion, with the argument that forward bending range is also based on pelvic, hip, thoracic spine, dural and shoulder mobility.
8 week
SF.36 Healthy life survey
The Short Form (36) Health Survey is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. Based on a much longer survey developed in the 1980's by Ware, J.E., the SF-36 has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.
8 week
Ultrasound examination of thoracolumbar fascia
thoracolumbar fascia Measurements and evaluation of TLF were obtained using single blind method when investigator didn't know any clinical information about a patient. Thickness of TLF was measured from both sides of a spine in the direction perpendicular to the skin. According to methodic of Langevin mentioned above TLF was divided to subdermal (SD) and supramuscular (SM). The general thickness of TLF is defined as the distance between deep border of the dermis and the superficial border of the muscle. TLF is hyperechogenic one or several layers (planes) structure which thickness is measured as a distance between the muscle and subdermal part of fascia.
8 week
Study Arms (2)
myofascial induction
ACTIVE COMPARATORTwice a week for 8 weeks. Lumbar interfacial field stroke application, Lumbar interfacial field to deep application, Lumbar region cross-hands induction technique, Hip flexor region induction.
Therapeutic Pain education
ACTIVE COMPARATORPain education,twice a week for 8 weeks. The mechanism of pain,Pain processing in the center, How sensitive the central nervous system is in chronic pain, Pain becomes chronic with the contribution of factors, Problems related to fear of pain will be explained in detail.
Interventions
Myofascial induction therapy is a therapy concept focused on optimizing function and balance within the fascial system. The approach aims at global recovery, local correction and painless body use.
Therapeutic pain education is a training intervention that aims to reduce pain and disability by helping patients better understand the biological processes that support pain states. The neurobiology of pain and pain processed by the nervous system is explained to the patient in detail. Changes the patient's olab viewpoint to pain. For example, the patient believes that the cause of pain is caused by tissue damage. The patient who receives pain training understands that the cause of pain is the hypersensitive central nervous system. As a result, the patient's fear avoidance behavior decreases and he starts to move more easily. Because the sensitivity of the central nervous system will be alleviated, the perceived pain will decrease.
Eligibility Criteria
You may qualify if:
- Between 25-65 years old
- Low back pain for at least 12 weeks
- Physical therapy in the last 1 month
- There is no other disease that may cause low back pain.
You may not qualify if:
- Stem pressure associated with pain
- Having severe discopathy
- Available compression fracture
- To have rheumatic or inflammatory disease that may cause back pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mehmet Unal
Kocaeli, Select..., 41100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director physiotherapist
Study Record Dates
First Submitted
September 21, 2018
First Posted
October 5, 2018
Study Start
November 20, 2018
Primary Completion
September 20, 2019
Study Completion
February 10, 2020
Last Updated
February 20, 2020
Record last verified: 2020-02