Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001168640
Ethics application status
Approved
Date submitted
15/10/2014
Date registered
6/11/2014
Date last updated
15/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of Thermovision technique of Dry Needling for gluteus minimus trigger points in people with and without sciatica
Scientific title
For subjects with and without sciatica with active trigger points (TrPs) within the gluteus minimus muscle as compared to non-TrPs participants, does Thermovision Technique of Dry Needling (TTDN) support the clinical criteria set by Travel and Simons and, thus, objectively confirm trigger points presence?
Secondary ID [1] 285495 0
None
Universal Trial Number (UTN)
U1111-1162-8110
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sciatica
myofascial pain 293284 0
Condition category
Condition code
Musculoskeletal 293550 293550 0 0
Other muscular and skeletal disorders
Neurological 293551 293551 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 293552 293552 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290434 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator: the control group will be non-TrPs healthy volunteers. They will receive TTDN in the most tender point, which will not fulfil the criteria for TrPs confirmation and will be needle silent.
Control group
Active

Outcomes
Primary outcome [1] 293368 0
Vasomotor response to TTDN (group A, B and C)

The calculation of expected vasomotor response in cm2 is assumed for the size above maximum skin temperature -vasodilatation and under minimum skin temperature -vasoconstriction (Thermography Studio 2007 Professional”) . The size of each vasomotor response will be recalculated from cm2 to the percentage value.
Skin temperature will be assessed by infrared thermovision camera
Timepoint [1] 293368 0
Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN
Primary outcome [2] 293433 0
Skin temperature (Tsk) changes (maximum, minimum, average) after TTDN.
Tsk will be assessed by infrared thermovision camera.
Timepoint [2] 293433 0
Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN
Secondary outcome [1] 310876 0
Comparison of the vasomotor response to three sessions of the TTDN (group A, B and C)

The calculation of expected vasomotor response in cm2 is assumed for the size above Tsk maximum (vasodilatation) and under Tsk minimum (vasoconstriction) ( “Thermography Studio 2007 Professional” ). The size of each vasomotor response will be recalculated from cm2 to the percentage value.

Tsk will be assessed by infrared thermovision camera.
Timepoint [1] 310876 0
Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN
Secondary outcome [2] 311038 0
Comparison of the skin temperature Tsk changes (maximum, minimum, average) to three sessions of the TTDN (group A, B and C).
Tsk will be assessed by infrared thermovision camera.
Timepoint [2] 311038 0
Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN

Eligibility
Key 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.
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Forty sciatica subjects (n=20 TrPs-positive and n=20 TrPs-negative) will be recruited to the study from Poznan GP doctors and the University Pain Clinic. Twenty healthy volunteers will be recruited by press announcement.
Sciatica subjects will be re-diagnosed by a neurologist towards radicular origin of sciatica on the basis of bedside examination, extensive neurological screening examination accompanied by a positive straight leg test, and magnetic resonance imaging results. Then, re-examination towards TrPs presence within the gluteus minimus muscle will be performed.
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 analyzed, namely group I: TrPs-positive sciatica, group II: TrPs-negative sciatica, group III: healthy volunteers. As a result, the information about the minimal size of the sample will be obtained (3 features* 2 gender categories* 2 types of vasomotor responses* the quantity of n=5 per subgroup; n=60).
For the strong evidence of data presented, the significance level will be set based on 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 be applied to compare the differences for maximum, minimum and average skin temperatures and the percentage size of expected autonomic phenomena for the state after dry needling and, secondly, for the post-observation state. Pearson correlation with a 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.
Secondly, the data from three TTDN sessions will be analyzed towards sensitivity and specificity of the obtained results (skin temperature changes and percentage size of vasomotor responses).
Values, figures and tables in the text will be expressed as + standard error of the mean (SEs). Significance level will be set at p

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/11/2014
Actual
17/11/2014
Date of last participant enrolment
Anticipated
28/11/2014
Actual
28/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6421 0
Poland
State/province [1] 6421 0

Funding & Sponsors
Funding source category [1] 290095 0
University
Name [1] 290095 0
Poznan University of Medical Sciences
Country [1] 290095 0
Poland
Primary sponsor type
University
Name
Poznan University of Medical Sciences
Address
Poznan University of Medical Sciences Fredry 10 61-701 Poznan
Country
Poland
Secondary sponsor category [1] 288801 0
None
Name [1] 288801 0
Address [1] 288801 0
Country [1] 288801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291803 0
Ethics Committee of Poznan University of Medical Sciences
Ethics committee address [1] 291803 0
Ethics committee country [1] 291803 0
Poland
Date submitted for ethics approval [1] 291803 0
26/09/2014
Approval date [1] 291803 0
02/10/2014
Ethics approval number [1] 291803 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52086 0
Dr Elzbieta Skorupska
Address 52086 0
Poznan University of Medical Sciences Fredry 10 61-701 Poznan
Country 52086 0
Poland
Phone 52086 0
+48694398333
Fax 52086 0
Email 52086 0
[email protected]
Contact person for public queries
Name 52087 0
Elzbieta Skorupska
Address 52087 0
Poznan University of Medical Sciences Fredry 10 61-701 Poznan
Country 52087 0
Poland
Phone 52087 0
+48694398333
Fax 52087 0
Email 52087 0
[email protected]
Contact person for scientific queries
Name 52088 0
Elzbieta Skorupska
Address 52088 0
Poznan University of Medical Sciences Fredry 10 61-701 Poznan
Country 52088 0
Poland
Phone 52088 0
+48694398333
Fax 52088 0
Email 52088 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseValidation and test-retest reliability of new thermographic technique called Thermovision Technique of Dry Needling for Gluteus Minimus Trigger Points in sciatica subjects and TrPs-negative healthy volunteers.2015https://dx.doi.org/10.1155/2015/546497
N.B. These documents automatically identified may not have been verified by the study sponsor.