Does Dry Needling Affect Treatment Outcomes of Interlaminar Epidural Steroid Injection in Cervical Disc Herniation?

Pain, Chronic Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914637
• Other study ID #: 09.2020.692
• Status: Completed
• Phase: N/A
• Start date: June 4, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 1, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Facial Pain
• Intervertebral Disc Displacement
• Neck Pain
• Pain, Chronic
• Pain, Neck

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pain severity from baseline to each checkpoints	Pain severity will be assessed with Numeric Rating Scale (NRS). The patient scores his/her pain between 0-10. Higher score indicates more severe pain	from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month
Primary	Change of the number of active trigger points from baseline to each checkpoints	The number of active trigger points will be determined by clinical examination. The trigger point will be defined as "active" if it causes spontaneous pain or pain occured during the examination is familiar to the patient.	from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary	Change of depression severity from baseline to each checkpoints	Severity of depression will be assessed with Beck Depression Inventory (BDI). BDI scoring ranges from 0 to 63, with a high score indicating an increased severity of depression.	from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary	Change of the number of the patients with neuropathic pain from baseline to each checkpoints	The number of patients with neuropathic pain will be assessed with Douleur Neuropathique 4 Questions (DN4). Scores = 4/10 indicate presence of neuropathic pain.	from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary	Change of the number of the patients with central sensitization from baseline to each checkpoints	The number of patients with central sensitization will be assessed with The number of patients with neuropathic pain will be assessed with Central Sensitisation Inventory (CSI). The CSI is composed of two parts: Part A and part B. Only Part A is scored and a score of more than 40 indicates the presence of central sensitisation.	from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary	Change of the measurement of quality of life from baseline to each checkpoints	The measurement of quality of life will be assessed with Short Form-12 Survey (SF-12). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). A high score indicates better quality of life.	from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary	Change of the measurement of disability related with chronic neck pain from baseline to each checkpoints	The measurement of disability will be assessed with Neck Disability Index (NDI). The NDI can be scored as a raw score (0-50) or doubled and expressed as a percent (0%-100%). A higher score indicates more activity limitation.	from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary	Change of the measurement of sleep quality from baseline to each checkpoints	The measurement of sleep quality will be assessed with Pittsburgh Sleep Quality Index (PSQI). 7 components are evaluated and each component is scored between 0-3; the total score is between 0-21. Higher total score indicates poor sleep quality.	from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary	Change of the pain sensitivity of active trigger points from baseline to each checkpoints	The measurement of pain sensitivity will be done by using manual algometer. Measurement will be made from active trigger points and the average of 3 measurements will be taken. The higher score indicates more resistance to pain.	from pre-interventional time to post-interventional 3rd week, 3rd month