Hyaluronidase for Trigger Point Injection in Myofascial Pain Syndrome

NCT02293083 | Completed

• 1 other identifier: 201003046001
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief 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 . 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.

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Degree of pain as measured by the verbal numerical rating scale

  within 2 weeks after intervention

Study Arms (2)

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

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

Drug: trigger point injection

Interventions

trigger point injection DRUG

Hyaluronidase; Lidocaine

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Aged 25-75 years
• Diagnosed with myofascial pain syndrome affecting both trapezius muscles

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical fellowship

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 18, 2014
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 18, 2014

Record last verified: 2014-11