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Paraspinal Stimulation in Treating MPS (DIMMST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014