Paraspinal Stimulation in Treating MPS

NCT ID: NCT01708343

Last Updated: 2012-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Clinical Study - RCT

Keywords

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Myofascial Pain Syndrome, intramuscular stimulation, acupuncture, sleep quality, pain threshold.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Placebo-sham

Placebo-sham twice a week during four weeks

Group Type SHAM_COMPARATOR

DIMMST

Intervention Type PROCEDURE

Lidocaine injection

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

Group Type ACTIVE_COMPARATOR

DIMMST

Intervention Type PROCEDURE

DIMMST

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

Group Type EXPERIMENTAL

DIMMST

Intervention Type PROCEDURE

Interventions

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DIMMST

Intervention Type PROCEDURE

Other Intervention Names

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Eletroacupuncture Myofascial pain

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Wolnei Caumo

MD, PhD, Professor and coordinator of Pain & Neuromodulation Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital de Clínicas E Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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WOLNEI CAUMO, MD, PhD

Role: CONTACT

Phone: 55-51-3359-8083

Email: [email protected]

CAUMO, MD., PhD

Role: CONTACT

Phone: 55-51-3359-8083

Email: [email protected]

Facility Contacts

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Jose R Goldim, PhD

Role: primary

Jose R Goldim, PhD

Role: primary

José R Goldim, PhD

Role: backup

JOSE GOLDIM, PhD

Role: primary

Other Identifiers

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MPS-DIMS

Identifier Type: -

Identifier Source: org_study_id