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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-sham | Sham Comparator | Placebo-sham twice a week during four weeks |
|
| Lidocaine injection | Active Comparator | Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks |
|
| DIMMST | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIMMST | Procedure |
|
|
| 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) |
| 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) |
| 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 |
Inclusion criteria
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WOLNEI CAUMO, MD, PhD | Contact | 55-51-3359-8083 | caumo@cpovo.net | |
| CAUMO, MD., PhD | Contact | 55-51-3359-8083 | caumo@cpovo.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| 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) |
| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
|
| Hospital de Clínicas E Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
|
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |