Relationship of Periostin and ODI, EQ-5D

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorKeimyung University Dongsan Medical Center

About this trial

The intervertebral disc degeneration (IVDD) is a widely recognized musculoskeletal disorder that impose a substantial socioeconomic burden and respresents one of the most important causes of low back pain. IVDD can result from a variety of factors, including aging, obesity, genetic predispositioin, degeneration of of the multifidus and psoas muscles, osteoporosis, inflammation, and oxidative stress.

The IVD consists of a central gelatinous nucleus pulposus (NP), an outer annulus fibrosus (AF), and superior and inferior cartilaginous endplates. The NP and AF produce a water-rich extracellular matrix (ECM), which is essential for normal trunk function.

Dysfunction of the NP and AF, together with excessive metabolic activity of the enplates triggered by various intrinsic and extrinsic stimuli, leads to endplate degeneration and calcification, and ultimately to IVDD. In addition to aging and mechanical overload, increased oxidative stress and pro-inflammatrory cytokine secretion further accelerate the progression of IVDD.

Periostin is an ECM protein which is associated with mechanical stress, inflammation, and aging, and is known to be closely involved in the development and progression of IVDD. Periostin binds to ECM molecule within the IVD and participates in its maintenance and repair; however, excessive ECM turn over drives IVD degeneration and its progression. Periostin influences IVD degeneration through mechanical stress and inflammatory pathways, and serum periostin levels are elevated in patients with severe IVD degeneration. A recent study demonstrated strong corrrelation between serum periostin concentration and the Pfirmann grading system.

The Oswestry disability index is a validated scale that measures functional disability in patients with spinal pain, and the EQ-5D is a breif questionnaire used to assess health related quality of life. Because serum periostin levels reflect the severity of IVDD, periostin may also influence patient's functional disability and quality of life. However, whether serum periostin concentration correlates with functional disability and quality of life has not yet been studied.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

lumbar disc herniation

lumbar spinal canal stenosis

patients who have MRI

patients who can fill in the ODI and EQ5D without other's help

Disqualifiers

allergic disease

allergic rhinitis

asthma

atopic dermatitis

Trial population

low back pain population with disc degeneration confirmed in MRI

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling for ELISA

    Other intervention

    blood sampling to detect the level of periostin and cytokine

Treatment groups

53 Participants
are divided into 1 treatment group
Group A: back pain patient group1 intervention

Trial outcomes

Primary outcomes

1

Identifying the correlation of periostin level and ODI and EQ5D

Time frame
Day1

Secondary outcomes

1

Identifying the correlation of the periostin level and Cytokine level and Pfirmann grading

Time frame
Day1

Other outcomes

Sponsors and contacts

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