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

Primary Purpose

Pain, Myofacial, Pain, Neck, Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cervical interlaminar epidural steroid injection
Dry needling
Sham dry needling
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Myofacial focused on measuring myofascial trigger point pain, disc, herniated, epidural injections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marmara University Pendik Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Other

Arm Label

interlaminar epidural steroid injection plus dry needling

interlaminar epidural steroid injection plus sham dry needling

interlaminar epidural steroid injection only

Arm Description

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.

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)

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 30, 2021
Last Updated
January 21, 2022
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04914637
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
October 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Myofacial, Pain, Neck, Pain, Chronic
Keywords
myofascial trigger point pain, disc, herniated, epidural injections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interlaminar epidural steroid injection plus dry needling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
interlaminar epidural steroid injection plus sham dry needling
Arm Type
Sham Comparator
Arm Description
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)
Arm Title
interlaminar epidural steroid injection only
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cervical interlaminar epidural steroid injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of pain severity from baseline to each checkpoints
Description
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
Time Frame
from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month
Title
Change of the number of active trigger points from baseline to each checkpoints
Description
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.
Time Frame
from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary Outcome Measure Information:
Title
Change of depression severity from baseline to each checkpoints
Description
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.
Time Frame
from pre-interventional time to post-interventional 3rd week, 3rd month
Title
Change of the number of the patients with neuropathic pain from baseline to each checkpoints
Description
The number of patients with neuropathic pain will be assessed with Douleur Neuropathique 4 Questions (DN4). Scores ≥ 4/10 indicate presence of neuropathic pain.
Time Frame
from pre-interventional time to post-interventional 3rd week, 3rd month
Title
Change of the number of the patients with central sensitization from baseline to each checkpoints
Description
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.
Time Frame
from pre-interventional time to post-interventional 3rd week, 3rd month
Title
Change of the measurement of quality of life from baseline to each checkpoints
Description
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.
Time Frame
from pre-interventional time to post-interventional 3rd week, 3rd month
Title
Change of the measurement of disability related with chronic neck pain from baseline to each checkpoints
Description
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.
Time Frame
from pre-interventional time to post-interventional 3rd week, 3rd month
Title
Change of the measurement of sleep quality from baseline to each checkpoints
Description
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.
Time Frame
from pre-interventional time to post-interventional 3rd week, 3rd month
Title
Change of the pain sensitivity of active trigger points from baseline to each checkpoints
Description
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.
Time Frame
from pre-interventional time to post-interventional 3rd week, 3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osman Hakan Gunduz, MD
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University Pendik Education and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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