Paraspinal Stimulation in Treating MPS (DIMMST)

Paraspinal Stimulation Combined With Trigger Point Needling and Needle Rotation in Treating Myofascial Pain: Randomized Sham-controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Clinical Study - RCT
• Intervention / Treatment: Procedure: DIMMST

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: WOLNEI CAUMO, MD, PhD; Phone Number: 55-51-3359-8083; Email: caumo@cpovo.net
• Study Contact Backup: Name: CAUMO, MD., PhD; Phone Number: 55-51-3359-8083; Email: caumo@cpovo.net

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
      • Contact: José R Goldim, PhD; Phone Number: 55 (51) 3359-8856; Email: jrgoldim@gmail.com
      • Principal Investigator: Wolnei Caumo, MD., PhD
      • Sub-Investigator: IRACI LS TORRES, PhD
      • Sub-Investigator: FELIPE GREGNI, PhD
    • Porto Alegre, RS, Brazil, 90035-003
      • Recruiting
      • Hospital de Clínicas E Porto Alegre
      • Contact: JOSE GOLDIM, PhD; Phone Number: 55 (51) 3359-8856.; Email: jrgoldim@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity	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).	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)
Pain threshold	Pain pressure threshold (PPT)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality - how did you feel when you woke up	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?	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)
Sleep quality - compared to your habitual sleep	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?	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)
Sleep quality -last night	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?	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical and mental Health	Health-related quality of life, assessed at baseline and the end of treatment sessions, was measured with the SF-12 Summary Scales	Before to begin treatment and after end treatment

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: October 9, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): October 16, 2012
• Last Update Submitted That Met QC Criteria: October 15, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: sleep quality,; Myofascial Pain Syndrome,; intramuscular stimulation,; acupuncture,; pain threshold.
• Other Study ID Numbers: MPS-DIMS