Myofascial Pain SyndromeNCT05009264
OMTrigger Inject- Treating Trigger Points: Comparing Muscle Energy Technique vs. Lidocaine Needling Technique
An observational study of Myofascial Pain Syndrome, run by AtlantiCare Regional Medical Center at 1 site in United States.
Trial summary
The primary aim of this study is to determine if osteopathic manipulative treatment is as effective to traditional lidocaine injection technique in treating myofascial trigger points in regard to post intervention pain intensity and quality of life. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- OMT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 31 May 2022
- Phase
- Observational
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is a prospective cohort study comprised of participants between ages 25-75 that presented to Atlanticare Regional Medical Center interventional pain department and Philadelphia College of Osteopathic Medicine Osteopathic Clinic between 2021 August and 2021 october with trigger point in the upper trapezius muscle. It is expected that approximately 60 patients will be enrolled to produce approximately 50 evaluable subjects.
Who may be able to join
- The subjects will only be recruited into the study if participants have met all the following criteria:
- Ages between 25 and 75 years.
- Previous or current diagnosis of MTrP in the upper trapezius region according to the criteria in reference
- 1 active/latent MTrP in the upper trapezius region
- The diagnostic criteria to establish myofascial trigger point is adopted from prior investiogators and include:
- Presence of palpable taut band in the skeletal muscle
Show all 10Show fewer
- Presence of hypersensitive tender spot in the taut band
- Presence of local twitch response upon stimulation of the taut band
- Reproduction of referred pain upon palpation
- Presence of spontaneous referred pain pattern
Who cannot join
- Exclusion criteria: Any subject that exhibits any of the following criteria will excluded from the study:
- Pregnancy or immunocompromise
- Fever/infection
- Previous history of whiplash injury
- Previous history of cervical surgery, cervical radiculopathy, or myelopathy
- Severe disc or cervical lesion
Show all 10Show fewer
- Evidence of cognitive deficit
- Degenerative or inflammatory disease of the cervical spine or shoulder, fibromyalgia, or neuromuscular diseases
- Use of medications (anticoagulants, anti-inflammatory etc.) or illicit drug use (1 week prior to treatment or follow up)
- Received treatment for MPS a month before the study recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site
AtlantiCare Regional Medical Center
Atlantic City, New Jersey, 08401
About this study
Official title: Treating Trigger Points: Comparing Muscle Energy Technique vs. Lidocaine Needling Technique for Pain Control and Quality of Life Measurements
The primary aim of this study is to determine if osteopathic manipulative treatment is as effective to traditional lidocaine injection technique in treating myofascial trigger points in regard to post intervention pain intensity and quality of life.
Read the detailed description
Myofascial pain syndrome is one of the most common musculoskeletal disorders seen in the aging US population. Its characterized by myofascial trigger points (MTPs) which were defined as hyperirritable nodules in a taut band of skeletal muscle, associated with pain on manual stretching, contraction, or stimulation of the muscle. Trigger points are further classified into active and latent based on their clinical features. Active MTPs are characterized by spontaneous pain at rest with referred pain on palpation whereas latent MTPs produce pain on palpation in addition to restriction of range of motion.
Currently, there are a variety of treatment options for MTPs including lidocaine injections, dry needling, osteopathic manipulative treatment, massage therapy, ultrasound therapy etc. There has been a lot of research investigating the safety and efficacy of dry needling and lidocaine trigger point injection techniques in treating MTPs. It was found that dry needling and lidocaine injections were both equally effective in reducing symptoms associated with MTPs as it was the mechanical disruption of the taut fibers due to the needle effect and the depth of adequate penetration that resulted in pain reduction more than the substance actually delivered into the muscle. Some authors also suggested the importance of a local twitch response (LTR); which is an observable contraction of the taut part of muscle band upon stimulation, during dry needling technique as being pertinent for maximum effectiveness. However, a recent systemic review found that LTR during dry needling treatment was unnecessary and not required for management of myofascial pain syndrome.
On the other hand, there has been fewer research investigating the effects of manual treatment on trigger points. Reasearchers had initially treated trigger points with ischemic compression but later changed their recommendation to applying gentle digital pressure to trigger points. A recent study done on traction-compression-stretch technique (TTCE) compared with ischemic compression showed some, albeit minor, increased outcome measures (pain pressure threshold) warranting clinical investigation. Another study compared active release and muscle energy techniques in treating latent trigger points of the upper trapezius and found that both techniques were equally effective in increasing cervical range of motion and decreasing pain and upper trapezius thickness. Other studies have also shown interest in similar osteopathic manipulative techniques such as counterstrain, myofascial release, facilitated positional release and high velocity-low amplitude thrust techniques in treating trigger points.
Studies have showed that the upper trapezius is one of the most common muscles affected by myofascial pain syndrome leading to referred pain manifesting as headaches and stiff neck.
Currently, there is no consensus as to which treatment method is superior, with the decision to treat in a certain way largely based upon the training received by the individual physician rather than the characteristics of the trigger point itself. There are no studies to date evaluating the efficacy of the various treatment options specifically osteopathic manipulative treatment vs. trigger point injections. Thus, the intention of the present study is to determine the efficacy rates of muscle energy techniques vs. lidocaine injections in treating MTPs in the upper trapezius region.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- OMT
- 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.
OMTProcedure or surgery
Also called muscle energy
OMT will be performed on identified areas of trapezius trigger points
| Study group | Role | What they receive |
|---|---|---|
| OMT Group | This group will receive OMT muscle energy as treatment for myofascial pain syndrome Receives: Procedure: OMT | |
| Injection Group | This group will receive lidocaine injections for myofascial pain syndrome Receives: Procedure: OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
0-10, measured using a point system; where 0 = no pain and 10 = maximum pain.
Measured: Prior to intervention
Measurement on quality of life, evaluate neck and upper extremity function.
Utilizing the neck disability index score which is used to evaluate neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicating more disability.
Measured: Prior to intervention
Pain Intensity
0-10, measured using a point system; where 0 = no pain and 10 = maximum pain.
Measured: Immediately after intervention
Measurement on quality of life, evaluate neck and upper extremity function.
Utilizing the neck disability index score which is used to evaluate neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicating more disability.
Measured: immediately after intervention
Pain Intensity
0-10, measured using a point system; where 0 = no pain and 10 = maximum pain.
Measured: 1 week after intervention
Measurement on quality of life, evaluate neck and upper extremity function.
Utilizing the neck disability index score which is used to evaluate neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicating more disability.
Measured: 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start12 Jan 2022
- Primary completion1 Mar 2022
- Study completion31 May 2022
Why it stopped: Principal investigator no longer working at our facility
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 Myofascial Pain SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtlantiCare Regional Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Philadelphia College of Osteopathic Medicine
- Responsible party
- Sponsor
- Investigators
- Brendan S Kelly, DO, Principal investigator, AtlantiCare Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009264
- Sponsor's protocol ID
- IRB 2021-1045
- Status last verified
- Jan 2025
- First submitted
- 16 Jul 2021
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a multisite study and information may be shared between the institutions
Publications
Hong CZ, Hsueh TC. Difference in pain relief after trigger point injections in myofascial pain patients with and without fibromyalgia. Arch Phys Med Rehabil. 1996 Nov;77(11):1161-6. doi: 10.1016/s0003-9993(96)90141-0.
PubMed 8931529
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Trigger Points: Comparing Muscle Energy Technique vs. Lidocaine Needling Technique for Pain Control and Quality of Life Measurements
- ClinicalTrials.gov ID
- NCT05009264
- Acronym / sponsor ID
- IRB 2021-1045
- Conditions
- Myofascial Pain Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal investigator no longer working at our facility
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AtlantiCare Regional Medical CenterUniversity, hospital or other
- Collaborators
- Philadelphia College of Osteopathic Medicine
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 17 Aug 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.
The primary aim of this study is to determine if osteopathic manipulative treatment is as effective to traditional lidocaine injection technique in treating myofascial trigger points in regard to post intervention pain intensity and quality of life.
Detailed description
Myofascial pain syndrome is one of the most common musculoskeletal disorders seen in the aging US population. Its characterized by myofascial trigger points (MTPs) which were defined as hyperirritable nodules in a taut band of skeletal muscle, associated with pain on manual stretching, contraction, or stimulation of the muscle. Trigger points are further classified into active and latent based on their clinical features. Active MTPs are characterized by spontaneous pain at rest with referred pain on palpation whereas latent MTPs produce pain on palpation in addition to restriction of range of motion.
Currently, there are a variety of treatment options for MTPs including lidocaine injections, dry needling, osteopathic manipulative treatment, massage therapy, ultrasound therapy etc. There has been a lot of research investigating the safety and efficacy of dry needling and lidocaine trigger point injection techniques in treating MTPs. It was found that dry needling and lidocaine injections were both equally effective in reducing symptoms associated with MTPs as it was the mechanical disruption of the taut fibers due to the needle effect and the depth of adequate penetration that resulted in pain reduction more than the substance actually delivered into the muscle. Some authors also suggested the importance of a local twitch response (LTR); which is an observable contraction of the taut part of muscle band upon stimulation, during dry needling technique as being pertinent for maximum effectiveness. However, a recent systemic review found that LTR during dry needling treatment was unnecessary and not required for management of myofascial pain syndrome.
On the other hand, there has been fewer research investigating the effects of manual treatment on trigger points. Reasearchers had initially treated trigger points with ischemic compression but later changed their recommendation to applying gentle digital pressure to trigger points. A recent study done on traction-compression-stretch technique (TTCE) compared with ischemic compression showed some, albeit minor, increased outcome measures (pain pressure threshold) warranting clinical investigation. Another study compared active release and muscle energy techniques in treating latent trigger points of the upper trapezius and found that both techniques were equally effective in increasing cervical range of motion and decreasing pain and upper trapezius thickness. Other studies have also shown interest in similar osteopathic manipulative techniques such as counterstrain, myofascial release, facilitated positional release and high velocity-low amplitude thrust techniques in treating trigger points.
Studies have showed that the upper trapezius is one of the most common muscles affected by myofascial pain syndrome leading to referred pain manifesting as headaches and stiff neck.
Currently, there is no consensus as to which treatment method is superior, with the decision to treat in a certain way largely based upon the training received by the individual physician rather than the characteristics of the trigger point itself. There are no studies to date evaluating the efficacy of the various treatment options specifically osteopathic manipulative treatment vs. trigger point injections. Thus, the intention of the present study is to determine the efficacy rates of muscle energy techniques vs. lidocaine injections in treating MTPs in the upper trapezius region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT Group | – | Procedure: OMTThis group will receive OMT muscle energy as treatment for myofascial pain syndrome |
| Injection Group | – | Procedure: OMTThis group will receive lidocaine injections for myofascial pain syndrome |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is a prospective cohort study comprised of participants between ages 25-75 that presented to Atlanticare Regional Medical Center interventional pain department and Philadelphia College of Osteopathic Medicine Osteopathic Clinic between 2021 August and 2021 october with trigger point in the upper trapezius muscle. It is expected that approximately 60 patients will be enrolled to produce approximately 50 evaluable subjects.
Key inclusion criteria (10 listed)
- The subjects will only be recruited into the study if participants have met all the following criteria:
- The diagnostic criteria to establish myofascial trigger point is adopted from prior investiogators and include:
- Presence of palpable taut band in the skeletal muscle
- Presence of hypersensitive tender spot in the taut band
- Presence of local twitch response upon stimulation of the taut band
Key exclusion criteria (10 listed)
- Exclusion criteria: Any subject that exhibits any of the following criteria will excluded from the study:
- Pregnancy or immunocompromise
- Fever/infection
- Previous history of whiplash injury
- Previous history of cervical surgery, cervical radiculopathy, or myelopathy
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 |
|---|---|---|
| OMTAlso: muscle energyOMT will be performed on identified areas of trapezius trigger points | Procedure or surgery | Injection Group, OMT Group |
Primary outcome
Pain Intensity
Time frame: Prior to intervention
0-10, measured using a point system; where 0 = no pain and 10 = maximum pain.
Measurement on quality of life, evaluate neck and upper extremity function.
Time frame: Prior to intervention
Utilizing the neck disability index score which is used to evaluate neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicating more disability.
Pain Intensity
Time frame: Immediately after intervention
0-10, measured using a point system; where 0 = no pain and 10 = maximum pain.
Measurement on quality of life, evaluate neck and upper extremity function.
Time frame: immediately after intervention
Utilizing the neck disability index score which is used to evaluate neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicating more disability.
Pain Intensity
Time frame: 1 week after intervention
0-10, measured using a point system; where 0 = no pain and 10 = maximum pain.
Measurement on quality of life, evaluate neck and upper extremity function.
Time frame: 1 week after intervention
Utilizing the neck disability index score which is used to evaluate neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicating more disability.
Results and safety
The study was stopped early (reason given: Principal investigator no longer working at our facility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Results publication: PubMed 8931529Hong CZ, Hsueh TC. Difference in pain relief after trigger point injections in myofascial pain patients with and without fibromyalgia. Arch Phys Med Rehabil. 1996 Nov;77(11):1161-6. doi: 10.1016/s0003-9993(96)90141-0.
- Individual participant dataSharing planned: Undecided. This is a multisite study and information may be shared between the institutions
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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.
Brendan S Kelly, DO principal investigator
AtlantiCare Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Pain Syndrome, run by AtlantiCare Regional Medical Center 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 10 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: stopped early, as of the sponsor's last update on 3 Feb 2025. 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.
Are results available for this study?
The study was stopped early (reason given: Principal investigator no longer working at our facility). Results are not available in the source record.
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?
Pain Intensity (time frame: Prior to intervention). The study lists 6 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 NCT05009264, 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 3 Feb 2025.