Myofascial Pain SyndromeNCT02293083
Hyaluronidase for Trigger Point Injection in Myofascial Pain Syndrome
A study testing trigger point injection in people with Myofascial Pain Syndrome, run by Samsung Medical Center.
Trial summary
Myofascial pain syndrome (MPS) is the most common cause of persistent regional pain characterized by myofascial trigger points. Trigger point injection (TPI) using local anesthetics is one of the most effective methods for treatment of MPS, and steroids or botulinum toxin can be added to local injections . Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- trigger point injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to May 2011
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- Aged 25-75 years
- Diagnosed with myofascial pain syndrome affecting both trapezius muscles
Who cannot join
- History of allergy to lidocaine or hyaluronidase
- Anticoagulant medication or antiplatelet agent within 5 days before the study
- Analgesic medication, including non-steroidal anti-inflammatory drugs, tramadol, acetaminophen, or opioids within 5 days of the study
- Pain related to trauma within 6 months before the study
- History of cervical or shoulder surgery
- TPI within 3 months in the same region
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- Fibromyalgia
- Cervical radiculopathy or myelopathy
- Obesity, defined as body mass index of 27.5 or higher
- Other medical or psychological conditions (cancer, rheumatoid arthritis, endocrine disease, major depression, schizophrenia)
About this study
Official title: Effect of Hyaluronidase Addition to Lidocaine for Trigger Point Injection in Myofascial Pain Syndrome
Myofascial pain syndrome (MPS) is the most common cause of persistent regional pain characterized by myofascial trigger points. Trigger point injection (TPI) using local anesthetics is one of the most effective methods for treatment of MPS, and steroids or botulinum toxin can be added to local injections .
Recent study suggested that the hyaluronan (HA) could be the basis of myofascial pain. HA within the deep fascia facilitates the free sliding of two adjacent fibrous fascial layers. If the HA assumes a more packed conformation, or more generally, if the loose connective tissue inside the fascia alters its density, the behavior of the entire deep fascia and the underlying muscle would be compromised.
Read more
The investigators anticipated that hyaluronidase could decrease the viscosity of HA near the muscle and fascia of trigger points. Meanwhile, hyaluronidase is thought to promote the spread of local anesthetic solution by hydrolyzing glycosidic bonds within HA. Hyaluronidase was shown to be effective in retro- and peribulbar block for ophthalmologic surgery or reducing tissue edema in dermatology, and adhesiolysis for some interventional pain managements.
However, the effect of the addition of hyaluronidase to local anesthetics during TPI has not been studied. The investigators aimed to compare the efficacy of TPI with the addition of hyaluronidase compared to local anesthetic alone on pain and quality of life in MPS patients.
Read the detailed description
Study approval was obtained from Institutional Review Board (IRB) of Samsung medical center, and written informed consent was obtained from all participants.
The required sample size was determined by power analysis on the basis of a previous study. The primary outcome was pain intensity in the posterior neck and upper back after TPI using verbal numerical rating scale (VNRS). The standard deviation of VNRS was assumed to be 20. Power calculations indicated that detecting 20 points difference in VNRS between the two groups (with α = 0.05 and β = 0.1) would require a sample of 29 subjects for each group. To account for dropouts, 33 subjects were recruited for each group.
Group L received TPI with a 3.2 ml of a 1:1 mixture of 1% lidocaine and 0.9% normal saline. Group H received TPI with the same volume of solution supplemented with hyaluronidase (H-LASE®, 1500 iu, L\&H Pharm., Seoul, Korea) 600 iu/ml. The investigators monitored vital sign and any signs of complications such as bleeding, hematoma, allergic reactions for 30 minutes. Treatment efficacy was evaluated by one of the authors (J.W.C.) using VNRS. To reduce bias, this evaluator and the participants were not informed of the assigned group.
Patients' characteristics such as age, height, weight, BMI and pretreatment neck disability index (NDI) and brief pain inventory (BPI) were analyzed by independent t-test. The sex distribution was analyzed by the chi-square test. P values were corrected by Bonferroni's method. Pretreatment VNRS and the duration of pain were evaluated by the Wilcoxon two-sample test. Repeated measures ANOVA was used to compare changes in the VNRS over time between the two groups. Pre- and post-TPI changes in NDI and BPI were compared between the two groups with the Wilcoxon signed rank test and the independent t-test, respectively. All analyses were performed with SPSS 18.0 (SPSS Inc., Chicago, IL, USA) statistical software. Significance was assumed for P values of less than 0.05.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- trigger point injection
- 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.
trigger point injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Group L received trigger point injection with a 3.2 ml of a 1:1 mixture of 1% lidocaine and 0.9% normal saline Receives: Drug: trigger point injection |
| Hyaluronidase | Experimental | Group H received trigger point injection with the same volume of solution supplemented with hyaluronidase (H-LASE®, 1500 iu, L\&H Pharm., Seoul, Korea) 600 iu/ml Receives: Drug: trigger point injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain as measured by the verbal numerical rating scale
Measured: within 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Won Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293083
- Sponsor's protocol ID
- 201003046001
- Status last verified
- Nov 2014
- First submitted
- 11 Nov 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronidase Addition to Lidocaine for Trigger Point Injection in Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT02293083
- Acronym / sponsor ID
- 201003046001
- Conditions
- Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Nov 2014 (estimated)
- 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 syndrome (MPS) is the most common cause of persistent regional pain characterized by myofascial trigger points. Trigger point injection (TPI) using local anesthetics is one of the most effective methods for treatment of MPS, and steroids or botulinum toxin can be added to local injections .
Recent study suggested that the hyaluronan (HA) could be the basis of myofascial pain. HA within the deep fascia facilitates the free sliding of two adjacent fibrous fascial layers. If the HA assumes a more packed conformation, or more generally, if the loose connective tissue inside the fascia alters its density, the behavior of the entire deep fascia and the underlying muscle would be compromised.
The investigators anticipated that hyaluronidase could decrease the viscosity of HA near the muscle and fascia of trigger points. Meanwhile, hyaluronidase is thought to promote the spread of local anesthetic solution by hydrolyzing glycosidic bonds within HA. Hyaluronidase was shown to be effective in retro- and peribulbar block for ophthalmologic surgery or reducing tissue edema in dermatology, and adhesiolysis for some interventional pain managements.
However, the effect of the addition of hyaluronidase to local anesthetics during TPI has not been studied. The investigators aimed to compare the efficacy of TPI with the addition of hyaluronidase compared to local anesthetic alone on pain and quality of life in MPS patients.
Detailed description
Study approval was obtained from Institutional Review Board (IRB) of Samsung medical center, and written informed consent was obtained from all participants.
The required sample size was determined by power analysis on the basis of a previous study. The primary outcome was pain intensity in the posterior neck and upper back after TPI using verbal numerical rating scale (VNRS). The standard deviation of VNRS was assumed to be 20. Power calculations indicated that detecting 20 points difference in VNRS between the two groups (with α = 0.05 and β = 0.1) would require a sample of 29 subjects for each group. To account for dropouts, 33 subjects were recruited for each group.
Group L received TPI with a 3.2 ml of a 1:1 mixture of 1% lidocaine and 0.9% normal saline. Group H received TPI with the same volume of solution supplemented with hyaluronidase (H-LASE®, 1500 iu, L\&H Pharm., Seoul, Korea) 600 iu/ml. The investigators monitored vital sign and any signs of complications such as bleeding, hematoma, allergic reactions for 30 minutes. Treatment efficacy was evaluated by one of the authors (J.W.C.) using VNRS. To reduce bias, this evaluator and the participants were not informed of the assigned group.
Patients' characteristics such as age, height, weight, BMI and pretreatment neck disability index (NDI) and brief pain inventory (BPI) were analyzed by independent t-test. The sex distribution was analyzed by the chi-square test. P values were corrected by Bonferroni's method. Pretreatment VNRS and the duration of pain were evaluated by the Wilcoxon two-sample test. Repeated measures ANOVA was used to compare changes in the VNRS over time between the two groups. Pre- and post-TPI changes in NDI and BPI were compared between the two groups with the Wilcoxon signed rank test and the independent t-test, respectively. All analyses were performed with SPSS 18.0 (SPSS Inc., Chicago, IL, USA) statistical software. Significance was assumed for P values of less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: trigger point injectionGroup L received trigger point injection with a 3.2 ml of a 1:1 mixture of 1% lidocaine and 0.9% normal saline |
| Hyaluronidase | Experimental | Drug: trigger point injectionGroup H received trigger point injection with the same volume of solution supplemented with hyaluronidase (H-LASE®, 1500 iu, L\&H Pharm., Seoul, Korea) 600 iu/ml |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults
- Aged 25-75 years
- Diagnosed with myofascial pain syndrome affecting both trapezius muscles
Key exclusion criteria (10 listed)
- History of allergy to lidocaine or hyaluronidase
- Anticoagulant medication or antiplatelet agent within 5 days before the study
- Analgesic medication, including non-steroidal anti-inflammatory drugs, tramadol, acetaminophen, or opioids within 5 days of the study
- Pain related to trauma within 6 months before the study
- History of cervical or shoulder surgery
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 | Drug | Hyaluronidase, Lidocaine |
Primary outcome
Degree of pain as measured by the verbal numerical rating scale
Time frame: within 2 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing trigger point injection in people with Myofascial Pain Syndrome, run by Samsung Medical Center.
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 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: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of pain as measured by the verbal numerical rating scale (time frame: within 2 weeks after intervention). 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 18 Nov 2014.