Clinical trial NCT01708343: Paraspinal Stimulation in Treating MPS
Official title: Paraspinal Stimulation Combined With Trigger Point Needling and Needle Rotation in Treating Myofascial Pain: Randomized Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Clinical Study - RCT
Keywords: Myofascial Pain Syndrome,
intramuscular stimulation,
acupuncture,
sleep quality,
pain threshold.
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 75
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain severity
timeFrame: 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)
measure: Pain threshold
timeFrame: 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)
Secondary outcomes:
measure: Sleep quality - how did you feel when you woke up
timeFrame: 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)
measure: Sleep quality - compared to your habitual sleep
timeFrame: 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)
measure: Sleep quality -last night
timeFrame: 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)
Other outcomes:
measure: Physical and mental Health
timeFrame: Before to begin treatment and after end treatment
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas E Porto Alegre
state: RS
Study officials:
References: