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Trial registered on ANZCTR


Trial ID
ACTRN12614001060639
Ethics application status
Approved
Date submitted
18/09/2014
Date registered
3/10/2014
Date last updated
20/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of sympathetic nerve activity on pain propagation in sciatica patients
Scientific title
For trigger points (TrPs) positive sciatica patients compared to TrPs-negative sciatica subjects, will dry needling provoke vasomotor reactions in the pain area, and thus confirm the influence of the sympathetic nerve activity in pain propagation of sciatica subjects?
Secondary ID [1] 285344 0
NN4042683 39
Universal Trial Number (UTN)
U1111-1161-7305
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sciatica 293059 0
myofascial pain 293060 0
Condition category
Condition code
Musculoskeletal 293331 293331 0 0
Other muscular and skeletal disorders
Neurological 293405 293405 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 293406 293406 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All of the sciatica subjects will be diagnosed by an experienced specialist for myofascial pain syndrome co-existence – gluteus minimus active trigger points presence based on Travell and Simons’ diagnostic criteria. Active trigger points (TrPs) were confirmed if spot tenderness, recognition of pain and digitally evoked referred pain pattern of the gluteus minimus were present. The localization of the most active trigger points or two most tender points (non-TrPs subjects) will be mark. After myofascial pain evaluation, all patients will be asked to define their pain level on the visual analogue scale and to draw their current pain pattern on a diagram. Then, infrared thermovision (IRT) camera side-to-side comparison of the painful area and the opposite extremity will be performed in the standing position. On the same day, patients will receive a dry needling session under infrared thermovision camera control regarding TrPs presence. The time of needling will be 5 minutes for every given point. During the whole procedure, the subarea of referred pain reported by the patient will be recorded. After the needling of the both marked points, further (6 consecutive minutes) thermovision imaging will be performed
Intervention code [1] 290245 0
Diagnosis / Prognosis
Intervention code [2] 290247 0
Treatment: Other
Comparator / control treatment
The control group will be subjects diagnosed as non-TrPs group. They will receive the same dry needling procedure but in neutral points (non-TrPs). The subjects will not receive the information about the trigger points diagnosis.
Control group
Active

Outcomes
Primary outcome [1] 293177 0
Trigger points presence by using Travell and Simon’s clinical criteria
Timepoint [1] 293177 0
just before the dry needling session under infrared thermovision camera control
Secondary outcome [1] 310508 0
Vasomotor response to dry needling (DN) under infrared thermovision (IRT) camera control
Timepoint [1] 310508 0
baseline, and 5 and 10 minutes of DN and 6 minutes of IRT observations post-DN

Eligibility
Key inclusion criteria
diagnosis of sciatica, age between 30 and 60 (inclusive); both lower limbs present, pain duration 1-3 months, >3 on the 1-10 point VAS scale of leg pain, with this being the dominant pain problem
Minimum age
30 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Fifty Caucasian patients with subacute sciatica will be recruited into the study. The patients will be recruited consecutively from the University Pain Clinic. All of the subjects will be diagnosed by an experienced specialist for myofascial pain syndrome co-existence – gluteus minimus active trigger points presence based on Travell and Simons’ diagnostic criteria. Then the patiens will be divided into two subgroups: TrPs-positive and TrPs-negative
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
According to William Cochran’s assumption for X2 test, to conduct the test the quantity of n=5 is required. It is assumed that in the examined group three subgroups will be present, namely:
Sciatica with trigger points co-existence
Sciatica without trigger points co-existence (needle silent)
Sciatica without trigger points co-existence (needle sensation)

Additionally, the subgroups will be analysed based on gender .
As a result, the information about the minimal size of the sample will be obtained (3 features * 2 gender categories * the quantity of n=5 per subgroup; n=30). However, for the strong evidence of data the examined will be n=50 because the prevalence of trigger points among sciatica patients is unknown.
For the strong evidence of data presented, the significance level will be set based on the exact tests, not on the default asymptotic method. Exact two-way Mann-Whitney U tests will be performed in order to ensure that data are representative of the whole population of possible data values. Tests will applied to compare the differences for maximum, minimum and average skin temperature and the percentage size of expected autonomic phenomena for the state after dry needling and secondly for the post-observation state. Pearson correlation with two-tailed significance test will be applied to define the dependency of the autonomic phenomenon occurrence. All comparisons will be completed, with trigger points co-existence being the differentiating criterion.
Values, figures and tables in the text will be expressed as + standard error of the mean (SEs). Significance level will be set at p<0.05. Statistical analysis will be performed using IBM SPSS Statistics, version 20".


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6352 0
Poland
State/province [1] 6352 0
wielkopolska

Funding & Sponsors
Funding source category [1] 289950 0
Government body
Name [1] 289950 0
National Science Centre
Address [1] 289950 0
Krolewska street No 57,
30-081 Krakow,
Poland
Country [1] 289950 0
Poland
Primary sponsor type
Government body
Name
National Science Centre
Address
Krolewska street No 57,
30-081 Krakow,
Poland
Country
Poland
Secondary sponsor category [1] 288647 0
University
Name [1] 288647 0
Poznan University of Medical Sciences
Address [1] 288647 0
Fredry street no 10
61-701 Poznan
Country [1] 288647 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291667 0
Ethics Committee of Poznan University of Medical Sciences
Ethics committee address [1] 291667 0
Fredry street 10
61-701 Poznan
Ethics committee country [1] 291667 0
Poland
Date submitted for ethics approval [1] 291667 0
29/05/2013
Approval date [1] 291667 0
13/06/2013
Ethics approval number [1] 291667 0
630/13

Summary
Brief summary
Short-term vasodilation after dry needling under IRT control of active TrPs was recorded in several cases and it is unknown whether noxious stimulation of every active trigger point can provoke vasomotor reactions. Moreover, the presence of trigger points in sciatica patients secondary to a primary lesion, e.g. a vertebral disc lesion, was suggested, but it is unknown how often they occur. The aim of this study is to evaluate the prevalence of active trigger points among subacute sciatica patients and response to dry needling under IRT control of TrPs positive and negative subacute sciatica patients.
Trial website
Trial related presentations / publications
Elzbieta Skorupska, Michal Rychlik and Wlodzimierz Samborski. Intensive vasodilatation in the sciatic pain area after dry needling.
BMC Complementary and Alternative Medicine 2015, 15:72 doi:10.1186/s12906-015-0587-6
Public notes

Contacts
Principal investigator
Name 51430 0
Dr Elzbieta Skorupska
Address 51430 0
Poznan University of Medical Sciences
Fredry 10
61-701 Poznan
Country 51430 0
Poland
Phone 51430 0
+48618310244
Fax 51430 0
Email 51430 0
skorupska@ump.edu.pl
Contact person for public queries
Name 51431 0
Dr Elzbieta Skorupska
Address 51431 0
Poznan University of Medical Sciences
Fredry 10
61-701 Poznan
Country 51431 0
Poland
Phone 51431 0
+48618310244
Fax 51431 0
Email 51431 0
skorupska@ump.edu.pl
Contact person for scientific queries
Name 51432 0
Dr Elzbieta Skorupska
Address 51432 0
Poznan University of Medical Sciences
Fredry 10
61-701 Poznan
Country 51432 0
Poland
Phone 51432 0
+48618310244
Fax 51432 0
Email 51432 0
skorupska@ump.edu.pl