Clinical trial NCT01742546: Effectiveness of Ultrasound Combine TENS in Treatment of Upper Trapezius Myofascial Pain
Official title: Effectiveness of Ultrasound Combine Transcutaneous Electrical Nerve Stimulation (TENS) in Treatment of Upper Trapezius Myofascial Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndromes
Keywords: myofascial pain syndrome
therapeutic ultrasound
combine therapy
Lead sponsor: Sirindhorn National Medical Rehabilitation Centre
Sponsor class: OTHER_GOV
First posted: 2012-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effectiveness of therapeutic ultrasound combine transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound in treatment of myofascial pain syndrome in upper trapezius muscle measured by mean change between pre and post treatment of pressure pain threshold (PPT), patient's complaint in pain intensity and the number of total tablet usage of acetaminophen in both groups.

Detailed description: Myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain and can affect any skeletal muscles in the body.Myofascial pain is not fatal condition but it can significant reduced quality of life and is a major cause of time lost from work. There are various treatments, which divided into invasive and non-invasive therapies. In the recent clinical practice, there is a new type of combine treatment unit which composes of electrotherapy and ultrasound therapy in one unit. However, there is no conclusive evidence for supports the effectiveness of this combine therapy compare with the conventional ultrasound in treatment of myofascial pain especially in aspect of pain relief.

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years old
* Clinical diagnosis of myofascial trigger point pain at upper trapezius muscle(s) persisted more than 1 week but less than 6 months before recruitment time, first or recurrence episodes
* Baseline VAS more than or equal 4 at upper trapezius muscle

Exclusion Criteria:

* During the past 2 weeks had received injection or physical therapy at upper trapezius muscle or shoulder area
* Had experience of ultrasound combine transcutaneous electrical nerve stimulation (TENS)
* Had history of accidence or severe trauma to shoulder region
* Had serious musculoskeletal condition that need surgical intervention such as acute shoulder subluxation, abnormal neurological examination
* Insensate skin or sensory impairment around shoulder area
* Skin infection at shoulder area
* Had contraindication for U/S such as cardiac pacemaker, implantation, malignancy in relevant area, bleeding disorder, acute inflammatory musculoskeletal disease, pregnancy, lactation
* Unable to communication
* Unable to complete treatment session and follow protocol

Primary outcomes:
measure: Evidence of pain relief by measured mean change between pre and post treatment of pressure pain threshold (PPT)
timeFrame: within two weeks or 10 times treatment-course
Secondary outcomes:
measure: Evidence of pain relief by visual analogue scale(VAS)
timeFrame: within two weeks or 10 times treatment- course
Other outcomes:
measure: Evidence of analgesic drug usage
timeFrame: within two weeks or 10 times treatment-course
Locations:
city: Muang
country: Thailand
facility: Sirindhorn National Medical Rehabilitation Centre
state: Nonthaburi
Study officials:
affiliation: Sirindhorn National Medical Rehabilitation Centre
name: Bootsakorn Loharjun, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: