Myofacial PainPhase 4NCT04640896
Trigger Point Injections in Anterior Cervical Surgery
A Phase 4 study testing Trigger point injection with bupivacaine, Trigger point injection with normal saline and Lidocaine skin wheal in people with Myofacial Pain and Pain, Neck, run by George Washington University at 1 site in United States.
Trial summary
To achieve appropriate exposure for an anterior neck surgery (for example an Anterior Cervical Discectomy and Fusion or ACDF), patients are positioned supine with their neck extended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofacial Pain, Pain, Neck, Pain, Back
- What is being tested?
- Trigger point injection with bupivacaine, Trigger point injection with normal saline and Lidocaine skin wheal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 31 Oct 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective anterior cervical surgery
Who cannot join
- Emergency surgery
- Local anesthetic allergy
- Long term opioid usage (not including tramadol and codeine)
- Intra-operative complication (e.g. unstable cervical spine)
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: Comparison of Trigger Point Injections Versus Traditional Therapies in the Management of Postsurgical Pain in Patients Who Had Anterior Cervical Surgery
To achieve appropriate exposure for an anterior neck surgery (for example an Anterior Cervical Discectomy and Fusion or ACDF), patients are positioned supine with their neck extended. Due to being in this position, patients frequently complain of posterior neck stiffness and pain postoperatively in addition to the anterior incisional pain. This posterior cervical pain can be classified as myofascial pain.
Cervical myofascial pain is thought to be the result of overuse or trauma to the supporting muscles of the neck and shoulders. Trigger point injections are one of the methods used to treat myofascial pain. The trigger point injection procedure is where a physician (typically an anesthesiologist) performs an exam of the patient neck and upper back and finds areas of point tenderness. The physician will then inject a small amount of numbing medication (such as bupivacaine) into the muscle or tissue in that area.
Read more
Trigger point injections have been shown to be superior to botox injections or dry needling, and equivalent to physical therapy. However, these studies were performed on patients with chronic neck pain. There are no studies evaluating the effectiveness of trigger point injections on post anterior cervical surgery patients.
At our institution, trigger point injections with local anesthetic are used as part of a multimodal pain control regimen for post-anterior cervical surgery patients. Our hypothesis is if the addition of trigger point injections to standard of care multi-modal post-operative pain control will decrease patients' myofascial pain, and thereby decrease the amount of narcotic pain medication used.
- Conditions
- Myofacial Pain, Pain, Neck, Pain, Back, Cervical Fusion
- Being tested
- Trigger point injection with bupivacaine, Trigger point injection with normal saline, Lidocaine skin wheal
- Medical subject headings
- Facial Pain, Neck Pain, Back Pain, Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger point injection with bupivacaineDrug
Trigger point injections will be performed within an hour of arrival in post anesthesia care unit, given that the patient has adequately woken up from general anesthesia. Injections will be performed by an anesthesiology provider using a standardized technique under strict aseptic conditions. The trigger point will be located between two fingers, and a 1-2cm sterile needle with a thickness of 25 or 26 gauge inserted at 30 degrees with respect to the skin. Negative aspiration will be confirmed before injecting the study solution. The needle will be withdrawn to the subcutaneous tissue and redirected superiorly, inferiorly, laterally and medially, injecting study solution at each location. Pressure will be applied to the area to ensure hemostasis, and the area dressed with gauze and tape as needed.
Trigger point injection with normal salineDrug
Trigger point injections will be performed within an hour of arrival in post anesthesia care unit, given that the patient has adequately woken up from general anesthesia. Injections will be performed by an anesthesiology provider using a standardized technique under strict aseptic conditions. The trigger point will be located between two fingers, and a 1-2cm sterile needle with a thickness of 25 or 26 gauge inserted at 30 degrees with respect to the skin. Negative aspiration will be confirmed before injecting the study solution. The needle will be withdrawn to the subcutaneous tissue and redirected superiorly, inferiorly, laterally and medially, injecting study solution at each location. Pressure will be applied to the area to ensure hemostasis, and the area dressed with gauze and tape as needed.
Lidocaine skin whealDrug
Patients in the control group will receive a small skin wheal of lidocaine. This will keep the patient blinded to the study group they are in since all patients will receive an injection.
However, this skin wheal is not considered a trigger point injection.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine skin wheal | Sham comparator | They will receive an injection of lidocaine in the skin over the area of the trigger points. While this causes a small area of numbness, it is not a trigger point injection. Receives: Drug: Lidocaine skin wheal |
| Trigger point injection with normal saline | Active comparator | Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.9% Normal Saline + intra- and postoperative standardized analgesia regimen Receives: Drug: Trigger point injection with normal saline |
| Trigger point injection with bupivacaine | Experimental | Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.25% bupivacaine hydrochloride + intra- and postoperative standardized analgesia regimen Receives: Drug: Trigger point injection with bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption in the First 6 Hour Period After Intervention (Trigger Point Injection/Sham)
Milligrams morphine equivalents (MME)
Measured: 6 hours after intervention
Opioid Consumption in the First 12 Hour Period After Intervention (Trigger Point Injection/Sham)
Milligrams morphine equivalents (MME)
Measured: 12 hours after intervention
Opioid Consumption in the First 24 Hour Period After Intervention (Trigger Point Injection/Sham)
Milligrams morphine equivalents
Measured: 24 hours after intervention
Secondary outcomes (4)
Pain Score at 6 Hours After Intervention (Trigger Point Injection/Sham).
Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.
Measured: 6 hours after intervention
Pain Score at 12 Hours After Intervention (Trigger Point Injection/Sham)
Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.
Measured: 12 hours after intervention
Pain Score at 24 Hours After Intervention (Trigger Point Injection/Sham)
Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.
Measured: 24 hours after intervention
Post-operative Length of Stay
Measured in days and hours
Measured: Through hospital discharge, an average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start5 Nov 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myofacial PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akhil Patel, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640896
- Sponsor's protocol ID
- NCR191932
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2020
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Trigger Point Injections Versus Traditional Therapies in the Management of Postsurgical Pain in Patients Who Had Anterior Cervical Surgery
- ClinicalTrials.gov ID
- NCT04640896
- Acronym / sponsor ID
- NCR191932
- Conditions
- Myofacial Pain, Pain, Neck, Pain, Back, Cervical Fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To achieve appropriate exposure for an anterior neck surgery (for example an Anterior Cervical Discectomy and Fusion or ACDF), patients are positioned supine with their neck extended. Due to being in this position, patients frequently complain of posterior neck stiffness and pain postoperatively in addition to the anterior incisional pain. This posterior cervical pain can be classified as myofascial pain.
Cervical myofascial pain is thought to be the result of overuse or trauma to the supporting muscles of the neck and shoulders. Trigger point injections are one of the methods used to treat myofascial pain. The trigger point injection procedure is where a physician (typically an anesthesiologist) performs an exam of the patient neck and upper back and finds areas of point tenderness. The physician will then inject a small amount of numbing medication (such as bupivacaine) into the muscle or tissue in that area.
Trigger point injections have been shown to be superior to botox injections or dry needling, and equivalent to physical therapy. However, these studies were performed on patients with chronic neck pain. There are no studies evaluating the effectiveness of trigger point injections on post anterior cervical surgery patients.
At our institution, trigger point injections with local anesthetic are used as part of a multimodal pain control regimen for post-anterior cervical surgery patients. Our hypothesis is if the addition of trigger point injections to standard of care multi-modal post-operative pain control will decrease patients' myofascial pain, and thereby decrease the amount of narcotic pain medication used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine skin wheal | Sham comparator | Drug: Lidocaine skin whealThey will receive an injection of lidocaine in the skin over the area of the trigger points. While this causes a small area of numbness, it is not a trigger point injection. |
| Trigger point injection with normal saline | Active comparator | Drug: Trigger point injection with normal salineTrigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.9% Normal Saline + intra- and postoperative standardized analgesia regimen |
| Trigger point injection with bupivacaine | Experimental | Drug: Trigger point injection with bupivacaineTrigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.25% bupivacaine hydrochloride + intra- and postoperative standardized analgesia regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective anterior cervical surgery
Key exclusion criteria (4 listed)
- Emergency surgery
- Local anesthetic allergy
- Long term opioid usage (not including tramadol and codeine)
- Intra-operative complication (e.g. unstable cervical spine)
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 |
|---|---|---|
| Trigger point injection with bupivacaineTrigger point injections will be performed within an hour of arrival in post anesthesia care unit, given that the patient has adequately woken up from general anesthesia. Injections will be performed by an anesthesiology provider using a standardized technique under strict aseptic conditions. The trigger point will be located between two fingers, and a 1-2cm sterile needle with a thickness of 25 or 26 gauge inserted at 30 degrees with respect to the skin. Negative aspiration will be confirmed before injecting the study solution. The needle will be withdrawn to the subcutaneous tissue and redirected superiorly, inferiorly, laterally and medially, injecting study solution at each location. Pressure will be applied to the area to ensure hemostasis, and the area dressed with gauze and tape as needed. | Drug | Trigger point injection with bupivacaine |
| Trigger point injection with normal salineTrigger point injections will be performed within an hour of arrival in post anesthesia care unit, given that the patient has adequately woken up from general anesthesia. Injections will be performed by an anesthesiology provider using a standardized technique under strict aseptic conditions. The trigger point will be located between two fingers, and a 1-2cm sterile needle with a thickness of 25 or 26 gauge inserted at 30 degrees with respect to the skin. Negative aspiration will be confirmed before injecting the study solution. The needle will be withdrawn to the subcutaneous tissue and redirected superiorly, inferiorly, laterally and medially, injecting study solution at each location. Pressure will be applied to the area to ensure hemostasis, and the area dressed with gauze and tape as needed. | Drug | Trigger point injection with normal saline |
| Lidocaine skin whealPatients in the control group will receive a small skin wheal of lidocaine. This will keep the patient blinded to the study group they are in since all patients will receive an injection. However, this skin wheal is not considered a trigger point injection. | Drug | Lidocaine skin wheal |
Primary outcome
Opioid Consumption in the First 6 Hour Period After Intervention (Trigger Point Injection/Sham)
Time frame: 6 hours after intervention
Milligrams morphine equivalents (MME)
Opioid Consumption in the First 12 Hour Period After Intervention (Trigger Point Injection/Sham)
Time frame: 12 hours after intervention
Milligrams morphine equivalents (MME)
Opioid Consumption in the First 24 Hour Period After Intervention (Trigger Point Injection/Sham)
Time frame: 24 hours after intervention
Milligrams morphine equivalents
4 secondary outcomes
Pain Score at 6 Hours After Intervention (Trigger Point Injection/Sham).
Time frame: 6 hours after intervention
Pain Score at 12 Hours After Intervention (Trigger Point Injection/Sham)
Time frame: 12 hours after intervention
Pain Score at 24 Hours After Intervention (Trigger Point Injection/Sham)
Time frame: 24 hours after intervention
Post-operative Length of Stay
Time frame: Through hospital discharge, an average of 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trigger point injection with bupivacaine, Trigger point injection with normal saline and Lidocaine skin wheal in people with Myofacial Pain and Pain, Neck, run by George Washington University at 1 site in United States.
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 1 inclusion and 4 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 13 Aug 2026. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opioid Consumption in the First 6 Hour Period After Intervention (Trigger Point Injection/Sham) (time frame: 6 hours after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.