Trigger Point Pain, Myofascial
Conditions
Brief summary
This study will evaluate the ability of trigger point injections completed immediately following a total knee arthroplasty decrease pain scores and opioid use compared to sham injections. Given the current state of opioid dependency in the United States there needs to be a more focused attempt at treating post-operative pain without use of opioids. Given the manipulation of soft tissue during a total knee arthroplasty there seems to be a high correlation with pain and myofascial pain syndrome. This study will include an experimental (trigger point injection) and control (sham injection) group who are all undergoing a total knee arthroplasty. This is a pilot study that will include a maximum of 100 total patients (although it is planned for the study to be much smaller with a planned 10-15 patients per group). The procedure that will be completed is a trigger point injection with use of 1% lidocaine without epinephrine along the distal aspect of the vastus medialis and lateralis, proximal aspect of the medial and lateral gastrocnemius muscle bellies. The sham injection will be completed by pressing the needle against the skin without injecting any fluid. There will be a "blind" between the patient and the needle with both arms of the study. These patients will be followed up on POD1, and during weeks 2 and 6 follow-up where they will be given questionnaires to assess pain (visual analogue scale) and opioid use, and asked to bring their opioid medications to the clinic to assess the morphine milligrams equivalent (MME).
Interventions
A trigger point injection utilizing lidocaine 1% without epinephrine will be injected into several muscles bellies immediately following surgery to halt a trigger point from forming. One group will receive this type of intervention and the sham group will not receive any type of injection.
OTHERSham Comparator
This arm of the study will not receive any injection.
Sponsors
David Grant U.S. Air Force Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 45 years or older * Planned to undergo primary total knee arthroplasty * Able to speak, read, and understand English * Willing to complete a study questionnaires * Willing to bring in their medications to be counted * DoD beneficiaries * No allergy to lidocaine * Not fearful of needles.
Exclusion criteria
* Chronic opioid users (daily use of prescribed opioids for at least 90 days) * Diagnosed with Fibromyalgia * Non-English speaking * Unable to read English * Unable to understand English * Pregnant * Allergy to lidocaine * Not willing to complete study questionnaires * Not willing to bring in their medications to be counted * Not a DoD beneficiary * Fearful of needles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores on the Visual Analog Scale | From enrollment to the end of treatment at 6 weeks | 1\. Change in Visual Analog Scale (VAS) pain scores The VAS is a numbered scale assessing pain severity using a number which describes the average level of pain since being discharged. Participants are to put a hash mark "/" on a numbered scale ranging from 0-100. Zero (0) is no pain and 100 is severe intolerable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | From enrollment to the end of treatment at 6 weeks | 1\. Compare the total opioid use between study groups (experimental, sham comparator). Opioid use will be measured during their inpatient stay using the Medication Administration Record (MAR) Summary in the electronic medical record; and completing an Opioid Use questionnaire and counting the number of pills remaining during post-operative/follow-up study visits. Inpatient opioid use will be calculated by using the morphine dosage and number of doses per day. Outpatient opioid use will be obtained by reviewing responses to the Opioid Use questionnaire and counting the number of pills remaining from the prescription given at the time of discharge. Participants will be asked to bring their medication (opioids) to their post-operative/follow-up study visits. This method will allow the investigator to measure total opioid use (injectable and pill) during their inpatient and outpatient course. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDustin L Bennett
David Grant
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| BMI | 33.84 kg/m^2 STANDARD_DEVIATION 4.29 |
| Number of Participants who are Military Retired or Military Dependents Dependents | 1 Participants |
| Number of Participants who are Military Retired or Military Dependents Retired | 3 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
None listed