Paraspinal Stimulation in Treating MPS

Phase 3

• Conditions: Clinical Study - RCT
• Interventions: Procedure: DIMMST

• Registration Number: NCT01708343
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2012-10
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-15
• Last Update Submitted: 2012-10-15
• Study First Posted: 2012-10-16
• Last Update Posted: 2012-10-16
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-sham	DIMMST	Placebo-sham twice a week during four weeks
Lidocaine injection	DIMMST	Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks
DIMMST	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

Primary Outcome Measures

Name	Time	Method
Pain severity	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)	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	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 pressure threshold (PPT)

Secondary Outcome Measures

Name	Time	Method
Sleep quality - 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 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	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 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	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 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?

Trial Locations

Locations (2)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Hospital de Clínicas E Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil