Paraspinal Stimulation in Treating MPS (DIMMST)

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 3

Conditions: Clinical Study - RCT

Treatments: Procedure: DIMMST

Study type: Interventional

Funder types: Other

Identifiers

NCT01708343

MPS-DIMS

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Placebo-sham

Sham Comparator group

Description:

Placebo-sham twice a week during four weeks

Treatment:

Procedure: DIMMST

Lidocaine injection

Active Comparator group

Description:

Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks

Treatment:

Procedure: DIMMST

DIMMST

Experimental group

Description:

DIMMST include the combination of trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR). Twice a week during four weeks

Treatment:

Procedure: DIMMST