Paraspinal Stimulation in Treating MPS

Study Overview
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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.

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

Conditions
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Clinical Study - RCT

Intervention / Treatment
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* Procedure: DIMMST


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo-sham<br>Placebo-sham twice a week during four weeks | Procedure: DIMMST<br> <br> * Other names: Myofascial pain;|
| Active Comparator: Lidocaine injection<br>Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks | Procedure: DIMMST<br> <br> * Other names: Myofascial pain;|
| Experimental: DIMMST<br>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<br> <br> * Other names: Myofascial pain;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial Pain Syndrome,, intramuscular stimulation,, acupuncture,, sleep quality,, pain threshold.