Paraspinal Stimulation in Treating MPS (DIMMST)

This study is currently recruiting participants.

Verified October 2012 by Hospital de Clinicas de Porto Alegre

Sponsor:

Information provided by (Responsible Party):

Wolnei Caumo, Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT01708343

First received: October 9, 2012

Last updated: October 15, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Clinical Study - RCT	Procedure: DIMMST	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Paraspinal Stimulation Combined With Trigger Point Needling and Needle Rotation in Treating Myofascial Pain: Randomized Sham-controlled Clinical Trial

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

Pain severity [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
Pain pressure threshold (PPT)

Secondary Outcome Measures:

Sleep quality - how did you feel when you woke up [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
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 Outcome Measures:

Physical and mental Health [ Time Frame: Before to begin treatment and after end treatment ] [ Designated as safety issue: No ]
Health-related quality of life, assessed at baseline and the end of treatment sessions, was measured with the SF-12 Summary Scales

Estimated Enrollment:	75
Study Start Date:	January 2011
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: Placebo-sham Placebo-sham twice a week during four weeks	Procedure: DIMMST Other Names: Eletroacupuncture Myofascial pain
Active Comparator: Lidocaine injection Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks	Procedure: DIMMST Other Names: Eletroacupuncture Myofascial pain
Experimental: 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	Procedure: DIMMST Other Names: Eletroacupuncture Myofascial pain

Eligibility

Ages Eligible for Study:	19 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708343

Contacts

Contact: WOLNEI CAUMO, MD, PhD	55-51-3359-8083	caumo@cpovo.net
Contact: CAUMO, MD., PhD	55-51-3359-8083	caumo@cpovo.net

Locations

Brazil
Hospital de Clínicas de Porto Alegre	Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Jose R Goldim, PhD 55 (51) 3359-8856. jrgoldim@gmail.com
Sub-Investigator: Iraci L Torres, PhD
Sub-Investigator: Felipe Fregni, PhD
Hospital de Clínicas de Porto Alegre	Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Jose R Goldim, PhD 55 (51) 3359-8856 jrgoldim@gmail.com
Contact: José R Goldim, PhD 55 (51) 3359-8856 jrgoldim@gmail.com
Principal Investigator: Wolnei Caumo, MD., PhD
Sub-Investigator: IRACI LS TORRES, PhD
Sub-Investigator: FELIPE GREGNI, PhD
Hospital de Clínicas E Porto Alegre	Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: JOSE GOLDIM, PhD 55 (51) 3359-8856. jrgoldim@gmail.com
Principal Investigator: WOLNEI CAUMO, PhD

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

More Information

No publications provided

Responsible Party:	Wolnei Caumo, MD, PhD, Professor and coordinator of Pain & Neuromodulation Lab, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT01708343 History of Changes
Other Study ID Numbers:	MPS-DIMS
Study First Received:	October 9, 2012
Last Updated:	October 15, 2012
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:

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

ClinicalTrials.gov processed this record on May 21, 2013

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