Pain, MyofacialNCT04914637
Does Dry Needling Affect Treatment Outcomes of Interlaminar Epidural Steroid Injection in Cervical Disc Herniation?
A study testing Cervical interlaminar epidural steroid injection and Dry needling in people with Pain, Myofacial and Pain, Neck, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Myofacial, Pain, Neck, Pain, Chronic
- What is being tested?
- Cervical interlaminar epidural steroid injection and Dry needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Education and Research Hospital
Istanbul
About this study
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.
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.
- Conditions
- Pain, Myofacial, Pain, Neck, Pain, Chronic
- Being tested
- Cervical interlaminar epidural steroid injection, Dry needling, Sham dry needling
- Keywords
- myofascial trigger point pain, disc, herniated, epidural injections
- Medical subject headings
- Facial Pain, Neck Pain, Chronic Pain, Myofascial Pain Syndromes, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical interlaminar epidural steroid injectionProcedure or surgery
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 needlingProcedure or surgery
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 needlingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| interlaminar epidural steroid injection plus dry needling | Active comparator | 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. Receives: Procedure: Cervical interlaminar epidural steroid injection; Procedure: Dry needling |
| interlaminar epidural steroid injection plus sham dry needling | Sham comparator | 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) Receives: Procedure: Cervical interlaminar epidural steroid injection; Procedure: Sham dry needling |
| interlaminar epidural steroid injection only | Other | 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. Receives: Procedure: Cervical interlaminar epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month
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.
Measured: from pre-interventional time to post-interventional 3rd week, 3rd month
Secondary outcomes (7)
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.
Measured: from pre-interventional time to post-interventional 3rd week, 3rd month
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.
Measured: from pre-interventional time to post-interventional 3rd week, 3rd month
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.
Measured: from pre-interventional time to post-interventional 3rd week, 3rd month
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.
Measured: from pre-interventional time to post-interventional 3rd week, 3rd month
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.
Measured: from pre-interventional time to post-interventional 3rd week, 3rd month
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.
Measured: from pre-interventional time to post-interventional 3rd week, 3rd month
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.
Measured: from pre-interventional time to post-interventional 3rd week, 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start4 Jun 2021
- Primary completion31 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, MyofacialStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osman Hakan Gunduz, MD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914637
- Sponsor's protocol ID
- 09.2020.692
- Status last verified
- Nov 2023
- First submitted
- 30 May 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39671525
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04914637
- Acronym / sponsor ID
- 09.2020.692
- Conditions
- Pain, Myofacial, Pain, Neck, Pain, Chronic
- Keywords
- myofascial trigger point pain, disc, herniated, epidural injections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| interlaminar epidural steroid injection plus dry needling | Active comparator | Procedure: Cervical interlaminar epidural steroid injection, Procedure: Dry needlingFluoroscopy-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. |
| interlaminar epidural steroid injection plus sham dry needling | Sham comparator | Procedure: Cervical interlaminar epidural steroid injection, Procedure: Sham dry needlingFluoroscopy-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) |
| interlaminar epidural steroid injection only | Other | Procedure: Cervical interlaminar epidural steroid injectionOnly 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical interlaminar epidural steroid injectionFluoroscopy-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. | Procedure or surgery | interlaminar epidural steroid injection only, interlaminar epidural steroid injection plus dry needling, interlaminar epidural steroid injection plus sham dry needling |
| Dry needlingDry 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. | Procedure or surgery | interlaminar epidural steroid injection plus dry needling |
| Sham dry needlingAlthough 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. | Procedure or surgery | interlaminar epidural steroid injection plus sham dry needling |
Primary outcome
Change of pain severity from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month
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
Time frame: from pre-interventional time to post-interventional 3rd week, 3rd month
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.
7 secondary outcomes
Change of depression severity from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 3rd week, 3rd month
Change of the number of the patients with neuropathic pain from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 3rd week, 3rd month
Change of the number of the patients with central sensitization from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 3rd week, 3rd month
Change of the measurement of quality of life from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 3rd week, 3rd month
Change of the measurement of disability related with chronic neck pain from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 3rd week, 3rd month
Change of the measurement of sleep quality from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 3rd week, 3rd month
Change of the pain sensitivity of active trigger points from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 3rd week, 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 39671525Yolcu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osman Hakan Gunduz, MD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical interlaminar epidural steroid injection and Dry needling in people with Pain, Myofacial and Pain, Neck, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain severity from baseline to each checkpoints (time frame: from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04914637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.