Clinical Study - RCT Clinical Trial
— DIMMSTOfficial title:
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.
| Status | Recruiting |
| Enrollment | 75 |
| Est. completion date | November 2012 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 19 Years to 50 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
| Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
| Brazil | Hospital de Clínicas E Porto Alegre | Porto Alegre | RS |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital de Clinicas de Porto Alegre |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No |
| Primary | 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) | Yes |
| Primary | 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) | Yes |
| Secondary | 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) | Yes |
| Secondary | 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) | Yes |
| Secondary | 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) | Yes |