Treating Trigger Points: Comparing Muscle Energy Technique vs. Lidocaine Needling Technique for Pain Control and Quality of Life Measurements
Conditions: Myofascial Pain Syndrome
Sponsor: AtlantiCare Regional Medical Center

OMT Trigger Point Protocol Cover Page 
 
 
 
 
 
Trial Name:  Treating Trigger Points: Comparing Muscle 
Energy Techniques vs. Lidocaine Needling Technique for Pain 
Control and Quality of Life Measures. 
NCT #: NCT05009264 
Document Date: April 28, 2022 

A comparison of effectiveness of muscle energy technique and dry needling injections on quality of 
life and pain control in treating trigger points
Introduction
Myofascial pain syndrome is one of the most common musculoskeletal disorders seen in the aging US 
population 1,2. Its characterized by myofascial trigger points (MTPs) which were first defined by Simons 
et al. (1999) as hyperirritable nodules in a taut band of skeletal muscle, associated with pain on manual 
stretching, contraction, or stimulation of the muscle3. Trigger points are further classified into active and 
latent based on their clinical features 4. 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 2,4–7. 
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 large 
amount of research investigating the safety and efficacy of dry needling and lidocaine trigger point 
injection techniques in treating MTPs. The results suggest 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 8–13. 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. 8,14However, a recent systemic review found that LTR during dry needling 
treatment was unnecessary and not required for management of myofascial pain syndrome 15. 
On the other hand, there has been fewer research investigating the effects of manual treatment on 
trigger points. Travell and Simons initially treated trigger points with ischemic compression but later 
changed their recommendation to applying gentle digital pressure to trigger points 16. A recent study 
done on traction-compression-stretch technique compared with ischemic compression showed some, 
albeit minor, increased outcome measures (pain pressure threshold) warranting clinical investigation 6. 
(We can use their comparative model and statistics since it would be similar to our concept)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 thickness7. 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 points3,16–18. 
Studies have showed that the upper trapezius is one of the most common muscles affected by 
myofascial pain syndrome 19,20 leading to referred pain manifesting as headaches and stiff neck. 
There is no consensus as to which treatment method is superior, with the decision to treat in a certain 
way/technique largely based upon the training received by the individual physician rather than the 
characteristics of the trigger point itself. There are currently no studies evaluating the efficacy of the 
various treatment options specifically osteopathic manipulative treatment vs. trigger point injections. 
Thus, the intention of the present study was to determine the efficacy rates of muscle energy 
techniques vs. dry needling in treating MTPs in the upper trapezius region. 
IRB NUMBER: 2021-1045
IRB Approved:  04/28/2022

Study Objective
The primary aim of this study is to observe whether osteopathic manipulative treatment or traditional 
lidocaine/dry needling technique is more efficacious or non-inferior and similar in treating myofascial 
trigger points in the upper trapezius region as it relates to quality of life and improvement in pain scores. 
Study Design
The study is a prospective cohort study comprised of participants between ages 25-75 presenting to 
Atlanticare Regional Medical Center interventional pain department and Philadelphia College of 
Osteopathic Medicine OMM Clinic between April 2021 and May 2021 with trigger point in the upper 
trapezius muscle. It is expected that approximately 60 patients will be enrolled to produce 
approximately 50 evaluable subjects. 
Inclusion Criteria: The subjects will only be recruited into the study if they have met all the following 
criteria: 

Ages between 25 and 60 years. 

Previous or current diagnosis of MTrP in the upper trapezius region according to the criteria set 
by Simons et al.3 

1 active/latent MTrP in the upper trapezius region
The diagnostic criteria to establish myofascial trigger point is adopted from Travell and Simons3 and 
include: 
1.
Presence of palpable taut band in the skeletal muscle
2.
Presence of hypersensitive tender spot in the taut band
3.
Presence of local twitch response upon stimulation of the taut band
4.
Reproduction of referred pain upon palpation
5.
Presence of spontaneous referred pain pattern 
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
-
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
IRB NUMBER: 2021-1045
IRB Approved:  04/28/2022

All the patients of interest that present to Atlanticare Regional Medical Center pain clinic and 
Philadelphia College of Osteopathic Medicine OMM Clinic that meet the relevant inclusion and exclusion 
criteria will be invited to participate in this study. The subjects will be informed of the purpose of the 
study and asked for informed consent. If recruited into the study, they will be administered a pre-
intervention survey. Subjects will then be managed according to standard of care by their point of care 
physician. Following the intervention they will be administered a post-intervention survey immediately 
following the intervention and one-week post. 
Pre-intervention assessment will include pain intensity/evaluation using point system and quality of life 
measured by the neck disability index. 
Post-intervention assessment will include pain intensity/evaluation using point system, administered 
immediately after the intervention, and one week following the intervention using phone survey or 
online survey depending on patient preference and comfort. 
Intervention
Group1 (PCOM): Will receive the muscle energy technique; trigger point isolated followed by post 
isometric relaxation muscle energy technique
Group 2 (Atlanticare Regional Medical Center): Will receive lidocaine injection technique
Outcome Measures
1.
Pain intensity; measured using a point system; where 0 = no pain and 10 = maximum pain. 
Although this is a subjective measurement by the patient, we are interested in looking at the 
difference between pre- and post-intervention pain intensity ratings. 
2.
Quality of Life; measured by the Neck disability Index22 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.
Neck Disability Index score rating23: 
0-4 points (0-8%) : no disability,
5-14 points ( 10 – 28%) : mild disability,
15-24 points (30-48% ) : moderate disability,
25-34 points (50- 64%) : severe disability,
35-50 points (70-100%) : complete disability
Procedure
Patients that consent to the study and are eligible following the inclusion & exclusion criteria will be 
recruited into the study. They will fill out the pre-intervention survey in the room. Once the survey is 
completed, the patient will be placed in a seated position and using palpation, the examiner will identify 
IRB NUMBER: 2021-1045
IRB Approved:  04/28/2022

the MTrP according to the criteria set by Simons et al. Following the subjective pre-assessment, the 
intervention will be performed. 
Group 1 will be primarily focused on patients from the OMM clinic at PCOM. Patients will be 
administered muscle energy technique of post isometric relaxation as per the Atlas of Osteopathic 
Techniques on the symptomatic upper trapezius without treatment of surrounding structures by the 
osteopathic attending physician. 
Group 2 will be comprised of patients from Atlanticare Regional Medical Center pain clinic and will be 
administered trigger point dry needling and lidocaine injection. The treatment will be administered by 
the pain clinic attending physician. After application of a coolant to numb the area, the isolated trigger 
point will be penetrated using a 30-gauge needle, to a depth adjusted depending on the patient, into the 
subcutaneous tissue. The patient will be warned about possible unpleasant sensations and mild pain 
associated with contraction of the tight band of muscle. Multiple needle insertions will be attempted to 
achieve MTrP inactivation, with the needle being withdrawn to the subcutaneous layer but not from the 
skin during each insertion, approximately lasting for 1-2 minutes 26,27. Once the fascial tension is 
relieved, 0.5% lidocaine will be injected, and the needle will be withdrawn from the skin. The procedure 
will be terminated with hemostasis achieved. 
Once the intervention is completed, the patient will be asked about the reduction in pain following the 
intervention and administered the post intervention survey. A week after the intervention, they will be 
called/emailed to ask about their pain intensity using the same post intervention survey by the medical 
students. 
Safety Management: 
Patients are free to withdraw from the study at any time should they choose to. Since the study 
procedures are not greater than minimal risk, adverse events are not expected. If any serious adverse 
effects or unaccounted events may occur, they will be reported to the IRB and patients will be 
discontinued from the study.  The data from withdrawn patients will not contribute to the study 
statistics.
Data Analysis
The data will be analyzed using SPSS version 27.0 for Windows (IBM Corp. Released 2020. IBM SPSS 
Statistics for Windows, Version 27.0. Armonk, NY: IBM Corp). Values of interest include measures of 
central tendency, i.e. mean, standard deviation, normal distribution, confidence intervals etc. To be 
considered a statistically significant finding, the alpha level will be set at 0.05. A descriptive analyses of 
the outcome variables will be conducted to compare between the intervention groups. The 
homogeneity of sociodemographic data (age, sex, comorbid conditions) and treatment groups will be 
analyzed using the Fischer test and Pearson chi square test, respectively. 
The outcome measures, reported pain and quality of life, will be analyzed separately using univariate 
analyses. The differences between the treatment groups across time periods will be analyzed. A two-
factor analysis of variance (ANOVA) will be performed for each dependent variable to determine the 
IRB NUMBER: 2021-1045
IRB Approved:  04/28/2022

difference between treatment groups at the different time points (before the intervention, immediately 
after the intervention, and a week post the intervention). A 2 x 3 mixed factor design will be used in 
order to evaluate the between subjects data (intervention type) across the repeated measures (three 
time periods). 
Study Administration
The primary records of data will be in form of pre- and post- intervention surveys. Each survey will 
contain a random code to link the patient to the survey data and that list will be kept separate from the 
surveys. All physical copies of data will be stored primarily at Dr. Brendan Kelly’s office under lock and 
key with key access only to them. Data collected through Atlanticare pain clinic will be maintained 
through one set of copies which will be stored at Dr. Dipty Mangla’s office under lock and key with key 
access only to them. Data collected through PCOM will be maintained through one set of copies which 
will be stored at Dr. Andrew Levin’s office under lock and key with key access only to them. Surveys 
administered through email will be sent through a secure link and all online data will be encrypted with 
access only to principal investigators and research personal. All data obtained through email will be 
stored on the principal investigator’s computer which is password protected. All data and records 
generated during this study will be kept confidential in accordance with Institutional policies and HIPAA 
on subject privacy and the investigator and other site personnel will not use the data and records for 
any purpose other than conducting the study. The identifiers and other data will be destroyed 5 years 
after study completion in compliance with the Atlanticare Regional Medical Center data retention policy. 
IRB NUMBER: 2021-1045
IRB Approved:  04/28/2022

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IRB NUMBER: 2021-1045
IRB Approved:  04/28/2022