Myofascial Pain Syndrome Clinical Trial
Official title:
Comparative Study of Shock Wave Therapy and Low Level Laser Therapy Effect in Patients With Myofascial Pain Syndrome of the Trapezius
Verified date | February 2018 |
Source | Petz Aladar County Teaching Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the effects of low level laser therapy and extracorporeal shock wave therapy in patients with myofascial pain syndrome of the upper trapezius. Half of the patients receive laser therapy, half of them receive shock wave therapy for three weeks.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients over 18 years of age with myofascial pain syndrome meeting the Simon's diagnostic criteria (5 major and 1 minor) for at least 8 weeks (chronic pain) - no physiotherapy or local injection within 3 months before starting the study Exclusion Criteria: - acute onset of neck pain - physiotherapy or local injection within 3 months before starting the study - abnormal lab test (ESR, hematology) - infection, fever - cervical radiculopathy - uncontrolled hypertension, anticoagulation or defect in blood coagulation - previous cervical operaton |
Country | Name | City | State |
---|---|---|---|
Hungary | Petz Aladár County Teaching Hospital | Gyor |
Lead Sponsor | Collaborator |
---|---|
Petz Aladar County Teaching Hospital |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in severity of pain at rest | change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain. | week 0 and week | |
Primary | change in severity of pain at rest | change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain. | week 0 and week 15 | |
Primary | change in severity of pressure pain | change from baseline severity of pressure pain recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain. | week 0 and week 3 | |
Primary | change in severity of pressure pain | change from baseline severity of pressure pain recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain. | week 0 and week 15 | |
Primary | change in function (percentage of disability) | change from baseline Neck Disability Index (NDI) at week 3. It includes 10 part; pain intensity, personal care, lifting objects, reading, headache, concentration, work, driving, sleeping and entertainments. There are six presumptions; the first is given 0 and the last presumption has the score of 5. The total maximum score is 50, that represents 100% disability. The lower score represents better outcome. | week 0 and week 3 | |
Primary | change in function (percentage of disability) | change from baseline Neck Disability Index (NDI) at week 15. It includes 10 part; pain intensity, personal care, lifting objects, reading, headache, concentration, work, driving, sleeping and entertainments. There are six presumptions; the first is given 0 and the last presumption has the score of 5. The total maximum score is 50, that represents 100% disability. The lower score represents better outcome. | week 0 and week 15 | |
Primary | change in quality of life | change from baseline quality of life (36-Item Short Form Health Survey /SF-36/) at week 3. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability. | week 0 and week 3 | |
Primary | change in quality of life | change from baseline quality of life (SF-36) at week 15. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability. | week 0 and week 15 |
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