Clinical Study - RCT
Conditions
Keywords
Myofascial Pain Syndrome,, intramuscular stimulation,, acupuncture,, sleep quality,, pain threshold.
Brief summary
To test the hypothesis that the effect of either multiple deep intramuscular stimulation therapy \[(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR)\] would be more effective than a placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for improving pain relief, sleep quality, and physical and mental state of the patient.
Interventions
PROCEDUREDIMMST
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Myofascial pain syndrome (MPS) (defined as regional pain, normal neurologic examination, presence of TrPs, taut bands, tender points, and pain characterized as dull, achy, or deep were relevant to MPS diagnosis. Additionally, palpable nodules, pain that is exacerbated by stress, decreased range of motion, and ropiness in the muscle). * Disability in the last three months: (defined if they had one or more these limitation in active and routine activities by MPS : (i) interference with work, (ii) enjoyable activities, (iii) responsibilities at home, (iv) relationships, (v) personal goals, (vi) thinking clearly, and problem solving, concentrating, or remembering during the last three months). * Women * Age: 19 to 50 years
Exclusion criteria
Rheumatoid arthritis Fibromyalgia Previous surgery on the affected areas Prior experience with acupuncture Primary radiculopathy Current use of psychotropic drugs (ilicits ) Habitual use of anti-inflammatory steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity | A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session) | a) The intensity of pain was measured by a 10-cm VAS \[30\]. VAS scores ranged from no pain (zero) to the worst possible pain (10 cm). |
| Pain threshold | A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session) | Pain pressure threshold (PPT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality - how did you feel when you woke up | A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session) | Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS: In general, how did you feel when you woke up? |
| Sleep quality - compared to your habitual sleep | A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session) | Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS: Assess the sleep quality of the previous night compared to your habitual sleep? |
| Sleep quality -last night | A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session) | Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS: How well did you sleep last night? |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical and mental Health | Before to begin treatment and after end treatment | Health-related quality of life, assessed at baseline and the end of treatment sessions, was measured with the SF-12 Summary Scales |
Countries
Brazil
Contacts
Primary ContactWOLNEI CAUMO, MD, PhD
Backup ContactCAUMO, MD., PhD
Outcome results
None listed