None listed
Conditions
Brief summary
The presence of the vasomotor reactions in the area where trigger point refer pain was presented. The new method for objective TrPs confirmation called TTDN was patented and awarded on the International Exhibition of Creativity and Innovation (among other awards). The method allows to record skin temperature changes and the size of the iso-area with vasomotor changes. The aim of this study is to validate TTDN
Interventions
Twenty TrPs-positive sciatica subjects (group A ) and twenty TrPs-negative (group B) and twenty healthy volunteers as a control (group C) will be recruited to the study. Each of the sciatica participants will draw his/her pain on a diagram and will define the pain on the visual analogue scale (VAS). The healthy volunteers will skip that part. All subjects will receive TTDN two consecutively days: on the first day – one session and on the second day – two sessions with one hour break. TTDN consis
Twenty TrPs-positive sciatica subjects (group A ) and twenty TrPs-negative (group B) and twenty healthy volunteers as a control (group C) will be recruited to the study. Each of the sciatica participants will draw his/her pain on a diagram and will define the pain on the visual analogue scale (VAS). The healthy volunteers will skip that part. All subjects will receive TTDN two consecutively days: on the first day – one session and on the second day – two sessions with one hour break. TTDN consist of: Infrared thermovision camera (IRT) side-to-side comparison of the lower limbs, dry needling (DN) session (2x5 minutes with the break on around 30s) and post-dry needling observation at rest (six consecutive minutes; without break after DN) under IRT control. The participants will be asked to report the area of referred pain (thigh, calf, foot) during the DN session. The participants and IRT camera operator will not be aware of the trigger point confirmation. During IRT session, a dry needling specialist will not be aware of the IRT camera results. Diagnostic criteria of active TrPs for sciatica subjects: active TrPs will be confirmed if referred pain typical of the gluteus minimus muscle (anterior/posterior fibers) will be evoked digitally and by needle from tender points within that muscle and the patients will recognize that referred pain as their daily complaint.
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Sciatica TrPs-negative subjects Key inclusion criteria: lack of active TrPs within gluteus minimus muscle, diagnosis of sciatica, age between 30 and 60 (inclusive), both lower limbs present, pain duration >3 months, >3 on the 1-10 point VAS scale of leg pain, with this being the dominant pain problem. Sciatica TrPs-positive subjects Key inclusion criteria: active TrPs within the gluteus minimus muscle, diagnosis of sciatica, age between 30 and 60 (inclusive), both lower limbs present, pain duration >3 months, >3 on the 1-10 point VAS scale of leg pain, with this being the dominant pain problem. Healthy volunteers Key inclusion criteria: general good health condition, age between 30 and 60 (inclusive), both lower limbs present, the lack of TrPs within the gluteus minimus, the lack of needle sensation of the most tender point within the gluteus minimus muscle.
Exclusion criteria
Sciatica (TrPs-postive and TrPs-negative) Key exclusion criteria: complex regional pain syndrome, cauda equina syndrome, previous back surgery, spinal tumors, scoliosis, pregnancy, coagulant treatment, disseminated intravascular coagulation, diabetes, epilepsy, infection, inflammatory rheumatologic diseases, stroke, or oncological history. Healthy volunteers Key exclusion criteria: previous back surgery, spinal tumors, scoliosis, pregnancy.
Outcome results
None listed