Does Dry Needling Affect Treatment Outcomes of Interlaminar Epidural Steroid Injection in Cervical Disc Herniation?
NCT ID: NCT04914637
Last Updated: 2023-11-29
Study Results
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Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2021-06-04
2021-11-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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interlaminar epidural steroid injection plus dry needling
Fluoroscopy-guided cervical interlaminar epidural steroid injection will be administered to patients with chronic neck pain due to cervical disc herniation. Also, dry needling will be applied to the active trigger points for the patients in this group.
Interlaminar epidural steroid injection will be applied at week 0, while dry needling will be applied in 3 sessions per week (week 0, week 1, week 2). The first session of the dry needling will be in the same day with interlaminar epidural steroid injection.
Cervical interlaminar epidural steroid injection
Fluoroscopy-guided cervical interlaminar epidural steroid injection will be administered to patients with chronic neck pain due to cervical disc herniation. The injection area is cleaned 3 times with an antiseptic solution and covered with a sterile cloth. Local anesthesia with 2 cc 3% prilocaine will be applied to the skin and subcutaneous tissues in the area of interest. Under fluoroscopy guidance, the needle is advanced into the C7-T1 intervertebral disc level. With the help of the loss of resistance technique, it is understood that the needle is in the epidural space, and second control is provided by administering contrast material. After the confirmation of needle place is done, a mixture of 12 mg dexamethasone, 1 cc 2% lidocaine, 1 cc saline is injected. The patient is taken to the rest room after the procedure and followed up for any complications.
Dry needling
Dry needling will be applied to the active trigger points for the patients in this group. After cleaning the area of interest with an antiseptic solution, dry needling will be applied with the fast-in/fast-out technique for the active trigger point. During needle maneuvers, local contractions (local twitch response-LTR) are obtained and rapid needle movements are continued until the contractions end. Afterwards, the needle is removed and compression is applied to ensure hemostasis in the relevant area.
interlaminar epidural steroid injection plus sham dry needling
Fluoroscopy-guided cervical interlaminar epidural steroid injection will be administered same as the arm titled "interlaminar epidural steroid injection plus dry needling". The only difference in the interventions in this arm is that dry needling is applied without penetrating the skin. The blunt tip of the needle will be used in sham intervention.
Interlaminar epidural steroid injection will be applied at week 0, while sham dry needling will be applied in 3 sessions per week (week 0, week 1, week 2)
Cervical interlaminar epidural steroid injection
Fluoroscopy-guided cervical interlaminar epidural steroid injection will be administered to patients with chronic neck pain due to cervical disc herniation. The injection area is cleaned 3 times with an antiseptic solution and covered with a sterile cloth. Local anesthesia with 2 cc 3% prilocaine will be applied to the skin and subcutaneous tissues in the area of interest. Under fluoroscopy guidance, the needle is advanced into the C7-T1 intervertebral disc level. With the help of the loss of resistance technique, it is understood that the needle is in the epidural space, and second control is provided by administering contrast material. After the confirmation of needle place is done, a mixture of 12 mg dexamethasone, 1 cc 2% lidocaine, 1 cc saline is injected. The patient is taken to the rest room after the procedure and followed up for any complications.
Sham dry needling
Although the method of intervention is like dry needling, the only difference is that the blunt end of the needle is used and it does not penetrate the skin.
interlaminar epidural steroid injection only
Only interlaminar epidural steroid injection will be administered to patients in this arm with the same method as in the other arms (one session, week 0). No dry needling or sham dry needling will be used.
Cervical interlaminar epidural steroid injection
Fluoroscopy-guided cervical interlaminar epidural steroid injection will be administered to patients with chronic neck pain due to cervical disc herniation. The injection area is cleaned 3 times with an antiseptic solution and covered with a sterile cloth. Local anesthesia with 2 cc 3% prilocaine will be applied to the skin and subcutaneous tissues in the area of interest. Under fluoroscopy guidance, the needle is advanced into the C7-T1 intervertebral disc level. With the help of the loss of resistance technique, it is understood that the needle is in the epidural space, and second control is provided by administering contrast material. After the confirmation of needle place is done, a mixture of 12 mg dexamethasone, 1 cc 2% lidocaine, 1 cc saline is injected. The patient is taken to the rest room after the procedure and followed up for any complications.
Interventions
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Cervical interlaminar epidural steroid injection
Fluoroscopy-guided cervical interlaminar epidural steroid injection will be administered to patients with chronic neck pain due to cervical disc herniation. The injection area is cleaned 3 times with an antiseptic solution and covered with a sterile cloth. Local anesthesia with 2 cc 3% prilocaine will be applied to the skin and subcutaneous tissues in the area of interest. Under fluoroscopy guidance, the needle is advanced into the C7-T1 intervertebral disc level. With the help of the loss of resistance technique, it is understood that the needle is in the epidural space, and second control is provided by administering contrast material. After the confirmation of needle place is done, a mixture of 12 mg dexamethasone, 1 cc 2% lidocaine, 1 cc saline is injected. The patient is taken to the rest room after the procedure and followed up for any complications.
Dry needling
Dry needling will be applied to the active trigger points for the patients in this group. After cleaning the area of interest with an antiseptic solution, dry needling will be applied with the fast-in/fast-out technique for the active trigger point. During needle maneuvers, local contractions (local twitch response-LTR) are obtained and rapid needle movements are continued until the contractions end. Afterwards, the needle is removed and compression is applied to ensure hemostasis in the relevant area.
Sham dry needling
Although the method of intervention is like dry needling, the only difference is that the blunt end of the needle is used and it does not penetrate the skin.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Principal Investigators
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Osman Hakan Gunduz, MD
Role: PRINCIPAL_INVESTIGATOR
Marmara University
Locations
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Marmara University Pendik Education and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Yolcu G, Toprak CS, Sencan S, Gunduz OH. Dry Needling Plus Cervical Interlaminar Epidural Steroid Injections: Do We Have More Favorable Results in Cervical Disc Herniation? A Randomized Sham-Controlled Clinical Study. Am J Phys Med Rehabil. 2024 Dec 1;103(12):1081-1087. doi: 10.1097/PHM.0000000000002509.
Other Identifiers
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09.2020.692
Identifier Type: -
Identifier Source: org_study_id