Clinical trial NCT04914637: Does Dry Needling Affect Treatment Outcomes of Interlaminar Epidural Steroid Injection in Cervical Disc Herniation?
Official title: The Effect of Dry Needling on the Treatment Outcomes of Interlaminar Epidural Steroid Injection in Patients With Chronic Neck Pain Due to Cervical Disc Herniation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Myofacial
Pain, Neck
Pain, Chronic
Keywords: myofascial trigger point pain
disc, herniated
epidural injections
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic neck pain is among the most frequently seen chronic painful conditions. As an important cause of disability, chronic neck pain is a musculoskeletal disorder that negatively affects quality of life. Cervical disc herniation is one of the leading causes of chronic neck pain and conservative methods such as exercise and pain medications are used first in the treatment. In patients unresponsive to conservative treatment, epidural steroid injection is successfully and frequently used treatment option. Epidural steroid injection in the cervical region can be applied with two approaches: interlaminar or transforaminal.

Myofascial trigger point characterized by intramuscular taut band and hypersensitive spots is a condition in which central and peripheral sensitization play a role in the pathophysiology. There are underlying myofascial trigger points in many etiologies that cause chronic neck pain. Trigger points can increase the severity of pain and in some cases they can be the main factor in the etiology of pain. Therefore, the presence of myofascial trigger points should be investigated, even if another cause is detected in chronic neck pain. Dry needling is an easily applicable and effective treatment option in myofascial trigger point.

Although it is well known that myofascial trigger points frequently accompany cervical disc herniation, their effect on treatment outcomes has not been investigated. In this study, we aimed to investigate the effect of dry needling for trigger points on the treatment results of interlaminar epidural steroid injection in patients diagnosed with cervical disc herniation.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65
* Chronic neck pain due to cervical disc herniation for at least 3 months and being unresponsive to conservative treatment
* Presence of at least one active myofascial trigger point on physical examination of cervical paraspinal muscles, scapulothoracic muscles and extremity muscles.

Exclusion Criteria:

* Previous surgical/interventional procedure for the cervical region
* Previous application of dry needling/acupuncture to any part of the body
* Presence of other musculoskeletal disorders (such as lateral epicondylitis, tendinitis, entrapment neuropathy) that may cause diagnostic confusion in terms of pain pattern and localization
* Signs of trauma, fracture, malignancy, or active infection
* Rheumatological (RA, AS, etc.), endocrinological (such as osteoporosis, Paget's disease) or another systemic disease that may change the anatomical or physiological structure of the relevant regions
* Presence of coagulopathy
* History of whiplash injury, cervical spinal stenosis, cervical spondylosis
* Have a diagnosis of fibromyalgia
* Being pregnant and breastfeeding
* Presence of mental deterioration or psychiatric/neurological disease that can affect flow of the study.

Primary outcomes:
measure: Change of pain severity from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month
measure: Change of the number of active trigger points from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary outcomes:
measure: Change of depression severity from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 3rd week, 3rd month
measure: Change of the number of the patients with neuropathic pain from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 3rd week, 3rd month
measure: Change of the number of the patients with central sensitization from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 3rd week, 3rd month
measure: Change of the measurement of quality of life from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 3rd week, 3rd month
measure: Change of the measurement of disability related with chronic neck pain from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 3rd week, 3rd month
measure: Change of the measurement of sleep quality from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 3rd week, 3rd month
measure: Change of the pain sensitivity of active trigger points from baseline to each checkpoints
timeFrame: from pre-interventional time to post-interventional 3rd week, 3rd month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Education and Research Hospital
Study officials:
affiliation: Marmara University
name: Osman Hakan Gunduz, MD
role: PRINCIPAL_INVESTIGATOR
References: