Myofascial PainPhase 2NCT04732507
Investigating the Minimum Number of Needling Required to Optimize Trigger Point Injections Outcome
A Phase 2 study testing 1% plain lidocaine and 0.25% plain bupivacaine in people with Myofascial Pain and Myofascial Trigger Point Pain, run by University of Arizona at 1 site in United States.
Trial summary
Myofascial pain is a common condition in which patients may experience severe chronic pain. The source of this pain is typically the soft tissue. Current methods to address myofascial pain include a procedure called Trigger point Injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain, Myofascial Trigger Point Pain
- What is being tested?
- 1% plain lidocaine and 0.25% plain bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 9 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Able to speak, read and write English
- Diagnosis of myofascial pain
- Failed conservative therapy or unable to participate in physical therapy
Who cannot join
- Serious mental illness that may not enable the patient to perceive pain changes
- History of conditions which may present as diffuse pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Banner University Medical Center Multispecialty Services Clinic
Tucson, Arizona, 85711
About this study
Myofascial pain is a common condition in which patients may experience severe chronic pain. The source of this pain is typically the soft tissue. Current methods to address myofascial pain include a procedure called Trigger point Injections. This method involves identifying the areas of muscles that are causing the pain. The most common way to perform trigger point injection involves infiltrating the muscle with local anesthetics and then repeatedly passing the numbing needle in and out of the muscles (needling). This procedure is successful for most patients. However, there is great variability in the way needling is done. Some pain physicians perform 1-2 needle passes while other pain physicians may exceed 20 passes. There are currently no guidelines as to the number or amount of needle passes needed to achieve pain control. Furthermore, there is no study or research to shed light on the relationship between the number of needles passes and the degree and duration of pain relief coupled with patients' satisfaction.
This study is proposed to address this gap in knowledge. It is a prospective and randomized clinical trial that follows the standard of care. The investigators will recruit patients from The University-Banner Medical Center at Tucson, Arizona chronic pain clinic who are candidates for trigger point injections. The participants will be randomized into 3 different groups. Group one will receive 2 needle passes per identified trigger point. Group two will receive ten needle passes per identified trigger point. Group three will receive twenty needle passes per identified trigger point.
The investigators will analyze the data to understand the relationship between the number of needles passes and the degree of pain relief, improved functional capacity, and patients' satisfaction.
Read the detailed description
Chronic pain affects over 100 million Americans with an annual cost of about $600 billion/year. Almost half of the chronic pain conditions are attributed to musculoskeletal conditions.
Musculoskeletal pain is typically identified with palpation over tender areas initially identified by the patient and then verified by the physician. There are typically areas of muscles that when palpated, pain is experienced by the patient. These points are known as Trigger Points. There are several ways to manage trigger points. Muscle relaxers are the most common pharmacological approaches to manage trigger points, but they can cause significant sedation for patients. Some non-pharmacological methods such as physical therapy may also provide some relief of musculoskeletal pain. However, physical therapy requires active participation from patients in addition to lifestyle modifications. Additionally, for some patients, the severity of their musculoskeletal pain precludes them from effectively participating in physical therapy. For those patients, trigger point injections may provide enough relief to effectively participate in physical therapy. Trigger point injections is a procedure where an area identified is first injected with a local anesthetic then the needle is repeatedly inserted in and out (needling). The exact mechanism of action is not clear, but it does provide significant relief for most patients with musculoskeletal pain. Interestingly enough, while trigger point injections are a very common procedure and are performed by almost all pain physicians, there is great variability in the method it is performed. There is currently no clear guidance as to how light or intense the "needling" aspect of the procedure should be. On one end of the spectrum, some pain physicians perform 1-2 needle passes. On the opposite end of the spectrum, other pain physicians perform 40-50 or more needle passes. The literature is not very clear as to which is better in terms of the number of passes. In fact, the range of passes from one study to the other may account for some inconsistencies of the outcome associated with performing trigger point injections. The greater the number of passes, the greater the risk for possible side effects. On the other hand, pain relief may be directly proportional to the number of passes. The investigators currently do not have such information. The purpose of this study is to understand the relationship between the intensity of the needling aspect of trigger point injections and pain relief. In this study, patients will undergo the typical standard of care treatment for musculoskeletal pain with randomization regarding the number of passes during needling. The investigators will evaluate the patient response using paper surveys over 2 months following their procedures.
- Conditions
- Myofascial Pain, Myofascial Trigger Point Pain
- Being tested
- 1% plain lidocaine and 0.25% plain bupivacaine
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% plain lidocaine and 0.25% plain bupivacaineCombination product
A 5- or 10-ml syringe will be filled equally with 1% plain lidocaine and 0.25% plain bupivacaine. A 1.5-inch 25-gauge needle will be attached to the syringe. The needle will be carefully inserted at the first trigger point and 2 mls of the mixed local anesthetic will be infiltrated. At that point, the needle will be carefully inserted into the trigger point based on the group assigned. Once needling is done for the first trigger point, the process will be repeated in exactly the same fashion for the remaining points.
| Study group | Role | What they receive |
|---|---|---|
| One to two needle passes | Active comparator | Receive 1-2 needle passes for needling at each trigger point Receives: Combination Product: 1% plain lidocaine and 0.25% plain bupivacaine |
| Ten needle passes | Active comparator | Receive 10 needle passes for needling at each trigger point Receives: Combination Product: 1% plain lidocaine and 0.25% plain bupivacaine |
| Twenty needle passes | Active comparator | Receive 20 needle passes for needling at each trigger point Receives: Combination Product: 1% plain lidocaine and 0.25% plain bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
The primary outcome is the length of time patients subjectively report at least 50 percent reduction in pain compared to their baseline following trigger point injections using the Numerical Pain Scale which ranges from 0-10, where 0 = no pain and 10 = the worst possible pain.
Measured: 60 days
Secondary outcomes (2)
Change in Sleep patterns
Change the Pittsburgh Sleep Quality Assessment Questionnaire by at least 30 percent. The Pittsburgh Sleep Quality Assessment Questionnaire has a scale from 0-21. The lower the score, the better the sleep quality.
Measured: 60 days
Perceived Subjective Changes in the Ability to Work, Do Chores, and Exercise.
Changes in abilities of the participants to work, do chores, and exercise by at least 30 percent. This will be assessed using subjective reports from the recruited participants. The participants will be asked to report their perceived changes in their ability to Work, do chores, and exercise. Zero percent indicates no change from baseline. one hundred percent indicates complete resolution of the perceived problem.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start20 Apr 2021
- Primary completion9 Dec 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Depending on assignment, one group will receive 1-2 needle passes at each trigger point, the other will receive 10 and the third will receive 20.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohab Ibrahim, PhD MD, University of Arizona
- Investigators
- Mohab Ibrahim, Md., Ph.D, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732507
- Sponsor's protocol ID
- 04122020
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2020
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Minimum Number of Needling Required to Optimize Trigger Point Injections Outcome
- ClinicalTrials.gov ID
- NCT04732507
- Acronym / sponsor ID
- 04122020
- Conditions
- Myofascial Pain, Myofascial Trigger Point Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 1 Feb 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.
Myofascial pain is a common condition in which patients may experience severe chronic pain. The source of this pain is typically the soft tissue. Current methods to address myofascial pain include a procedure called Trigger point Injections. This method involves identifying the areas of muscles that are causing the pain. The most common way to perform trigger point injection involves infiltrating the muscle with local anesthetics and then repeatedly passing the numbing needle in and out of the muscles (needling). This procedure is successful for most patients. However, there is great variability in the way needling is done. Some pain physicians perform 1-2 needle passes while other pain physicians may exceed 20 passes. There are currently no guidelines as to the number or amount of needle passes needed to achieve pain control. Furthermore, there is no study or research to shed light on the relationship between the number of needles passes and the degree and duration of pain relief coupled with patients' satisfaction.
This study is proposed to address this gap in knowledge. It is a prospective and randomized clinical trial that follows the standard of care. The investigators will recruit patients from The University-Banner Medical Center at Tucson, Arizona chronic pain clinic who are candidates for trigger point injections. The participants will be randomized into 3 different groups. Group one will receive 2 needle passes per identified trigger point. Group two will receive ten needle passes per identified trigger point. Group three will receive twenty needle passes per identified trigger point.
The investigators will analyze the data to understand the relationship between the number of needles passes and the degree of pain relief, improved functional capacity, and patients' satisfaction.
Detailed description
Chronic pain affects over 100 million Americans with an annual cost of about $600 billion/year. Almost half of the chronic pain conditions are attributed to musculoskeletal conditions.
Musculoskeletal pain is typically identified with palpation over tender areas initially identified by the patient and then verified by the physician. There are typically areas of muscles that when palpated, pain is experienced by the patient. These points are known as Trigger Points. There are several ways to manage trigger points. Muscle relaxers are the most common pharmacological approaches to manage trigger points, but they can cause significant sedation for patients. Some non-pharmacological methods such as physical therapy may also provide some relief of musculoskeletal pain. However, physical therapy requires active participation from patients in addition to lifestyle modifications. Additionally, for some patients, the severity of their musculoskeletal pain precludes them from effectively participating in physical therapy. For those patients, trigger point injections may provide enough relief to effectively participate in physical therapy. Trigger point injections is a procedure where an area identified is first injected with a local anesthetic then the needle is repeatedly inserted in and out (needling). The exact mechanism of action is not clear, but it does provide significant relief for most patients with musculoskeletal pain. Interestingly enough, while trigger point injections are a very common procedure and are performed by almost all pain physicians, there is great variability in the method it is performed. There is currently no clear guidance as to how light or intense the "needling" aspect of the procedure should be. On one end of the spectrum, some pain physicians perform 1-2 needle passes. On the opposite end of the spectrum, other pain physicians perform 40-50 or more needle passes. The literature is not very clear as to which is better in terms of the number of passes. In fact, the range of passes from one study to the other may account for some inconsistencies of the outcome associated with performing trigger point injections. The greater the number of passes, the greater the risk for possible side effects. On the other hand, pain relief may be directly proportional to the number of passes. The investigators currently do not have such information. The purpose of this study is to understand the relationship between the intensity of the needling aspect of trigger point injections and pain relief. In this study, patients will undergo the typical standard of care treatment for musculoskeletal pain with randomization regarding the number of passes during needling. The investigators will evaluate the patient response using paper surveys over 2 months following their procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Depending on assignment, one group will receive 1-2 needle passes at each trigger point, the other will receive 10 and the third will receive 20.
| Arm | Type | Receives |
|---|---|---|
| One to two needle passes | Active comparator | Combination Product: 1% plain lidocaine and 0.25% plain bupivacaineReceive 1-2 needle passes for needling at each trigger point |
| Ten needle passes | Active comparator | Combination Product: 1% plain lidocaine and 0.25% plain bupivacaineReceive 10 needle passes for needling at each trigger point |
| Twenty needle passes | Active comparator | Combination Product: 1% plain lidocaine and 0.25% plain bupivacaineReceive 20 needle passes for needling at each trigger point |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to speak, read and write English
- Diagnosis of myofascial pain
- Failed conservative therapy or unable to participate in physical therapy
Key exclusion criteria (2 listed)
- Serious mental illness that may not enable the patient to perceive pain changes
- History of conditions which may present as diffuse pain
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 |
|---|---|---|
| 1% plain lidocaine and 0.25% plain bupivacaineA 5- or 10-ml syringe will be filled equally with 1% plain lidocaine and 0.25% plain bupivacaine. A 1.5-inch 25-gauge needle will be attached to the syringe. The needle will be carefully inserted at the first trigger point and 2 mls of the mixed local anesthetic will be infiltrated. At that point, the needle will be carefully inserted into the trigger point based on the group assigned. Once needling is done for the first trigger point, the process will be repeated in exactly the same fashion for the remaining points. | Combination product | One to two needle passes, Ten needle passes, Twenty needle passes |
Primary outcome
Change in pain intensity
Time frame: 60 days
The primary outcome is the length of time patients subjectively report at least 50 percent reduction in pain compared to their baseline following trigger point injections using the Numerical Pain Scale which ranges from 0-10, where 0 = no pain and 10 = the worst possible pain.
2 secondary outcomes
Change in Sleep patterns
Time frame: 60 days
Perceived Subjective Changes in the Ability to Work, Do Chores, and Exercise.
Time frame: 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Related trials for Myofascial Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
Recruiting
Platelets Rich Plasma Injection Versus Physiologic Saline Injection for Treatment of Myofascial Pain
Platelets Rich Plasma, Saline
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
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.
Mohab Ibrahim, Md., Ph.D principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1% plain lidocaine and 0.25% plain bupivacaine in people with Myofascial Pain and Myofascial Trigger Point Pain, run by University of Arizona 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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 8 Jan 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 in pain intensity (time frame: 60 days). 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 8 Jan 2026.