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Trial registered on ANZCTR


Registration number
ACTRN12614001188628
Ethics application status
Approved
Date submitted
15/10/2014
Date registered
12/11/2014
Date last updated
21/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Trigger point related vasomotor response to dry needling in patients with low back pain referred to the leg and healthy volunteers
Scientific title
For trigger points (TrPs) positive low back pain referred to the leg patients and TrPs-positive healthy volunteers as compared to TrPs-negative low back pain referred to the leg patients and TrPs-negative healthy volunteers, will dry needling provoke vasomotor reactions in the pain area and, thus, confirm the influence of sympathetic nerve activity on trigger point pain propagation.
Secondary ID [1] 285494 0
None
Universal Trial Number (UTN)
U1111-1162-8072
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain reffered to leg 293283 0
Condition category
Condition code
Musculoskeletal 293547 293547 0 0
Other muscular and skeletal disorders
Neurological 293548 293548 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 293549 293549 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Forty chronic low back pain radiating down patients (experimental group) will be recruited to the study from Poznan GP doctors and the University Pain Clinic. Thirty healthy volunteers will be recruited by press announcement.
Experimental group will be examined towards TrPs presence within the gluteus minimus. After that subjects will be assigned to four groups; group I: TrPs-positive experimental (n=20), group II: TrPs-negative experimental (n=20), group III: TrPs-negative control (n=15), and group IV: TrPs-positive control (n=15).
Each of the participants will draw his/her pain on a diagram and define the pain on the visual analogue scale (VAS).
Before the Infrared Thermovision camera (IRT) session, the presence of active TrPs for experimental and control within the gluteus minimus muscle will be re-examined. After that IRT side-to-side comparison of the lower limb will be performed and then all participants will receive the dry needling (DN) session (2x 5 minutes with the 30 second break) and post-dry needling observation at rest (six consecutive minutes) under IRT control. DN will be performed within the gluteus minimus muscle into: two TrPs (group I and group IV) or two the most tender points (group II and group III). The area to be observed by IRT will be chosen according to the gluteus minimus referred pain pattern. Additionally, during DN participants will be asked to report the area of referred pain (thigh, calf, foot). The participants and IRT camera operator will not be aware of the myofascial pain diagnosis results. During IRT, the dry needling specialist will not be aware of the IRT camera results.
The dry needling under IRT control will be conducted once.
Diagnostic criteria of active TrPs for experimental group: 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. If a patient of the experimental is needle-positive only but he/she does not recognize referred pain evoked by the needle as familiar, the presence of active TrPs will also be confirmed but with the note “likely TrPs” as additional description.
For healthy volunteers (control), only latent TrPs are possible to be present. Diagnostic criteria for the control group: latent TrPs within the gluteus minimus muscle will be confirmed if digital pressure of the most tender point within that muscle provokes referred pain typical of gluteus minimus muscle TrPs. Similarly to the experimental group, when only the needle-evoked referred pain occurs –likely TrPs (latent form) will be confirmed.
Intervention code [1] 290433 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator: the control group will be non-TrPs healthy volunteers and non-TrPs low back pain radiating down subjects. They will receive the same dry needling procedure but in the most tender point which will not fulfil the criteria for TrPs confirmation.
Control group
Active

Outcomes
Primary outcome [1] 293367 0
Vasomotor response to dry needling under infrared thermovision camera control of non-TrPs low back pain radiating down subjects and TrPs-positive healthy volunteers (if present)
Timepoint [1] 293367 0
Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN
Primary outcome [2] 293434 0
Skin temperature response to dry needling under IRT control of TrPs-positive low back pain radiating down subjects and TrPs-positive healthy volounteers
Timepoint [2] 293434 0
Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN
Secondary outcome [1] 310875 0
Size evaluation of vasomotor response to dry needling under infrared thermovision camera control regarding the presence of active, latent, likely TrPs
Timepoint [1] 310875 0
Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN
Secondary outcome [2] 311039 0
Skin temperature response to dry needling under IRT control regarding the presence of active, latent, likely TrPs
Timepoint [2] 311039 0
Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN

Eligibility
Key inclusion criteria
Experimental group
Key inclusion criteria: low back pain radiating down, age between 20 and 60 (inclusive), both lower limbs present, pain duration >3 months, >3 on the 1-10 point VAS scale;leg pain, with this being the dominant pain problem.

Healthy volunteers
Key inclusion criteria: general good health condition, age between 20 and 60 (inclusive), both lower limbs present
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Experimental group

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 chronic low back pain radiating down patients (experimental group) will be recruited to the study from Poznan GP doctors and the University Pain Clinic. Thirty healthy volunteers will be recruited by press announcement.
Experimental group will be examined towards TrPs presence within the gluteus minimus. After that subjects will be assigned to four groups; group I: TrPs-positive experimental (n=20), group II: TrPs-negative experimental (n=20), group III: TrPs-negative control (n=15), and group IV: TrPs-positive control (n=15).
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 four subgroups will be present, namely group I: TrPs-positive experimental, group II: TrPs-negative experimental, group III: TrPs-negative control, and group IV: TrPs-positive control. Among non-TrPs subjects (experimental and control) the needle sensitive participants will be analyzed. As a result, the information about the minimal size of the sample will be obtained (6 features* 2 types of vasomotor responses*the quantity of n=5 per subgroup; n=60). However, for the strong evidence of data the examined group will be n=70.
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.
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
17/11/2014
Actual
20/11/2014
Date of last participant enrolment
Anticipated
5/12/2014
Actual
18/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 6420 0
Poland
State/province [1] 6420 0

Funding & Sponsors
Funding source category [1] 290094 0
University
Name [1] 290094 0
Poznan University of Medical Sciences
Country [1] 290094 0
Poland
Primary sponsor type
University
Name
Poznan University of Medical Sciences
Address
Fredry street no 10
61-701 Poznan
Country
Poland
Secondary sponsor category [1] 288799 0
None
Name [1] 288799 0
Address [1] 288799 0
Country [1] 288799 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291802 0
Ethics Committee of Poznan University of Medical Sciences
Ethics committee address [1] 291802 0
Ethics committee country [1] 291802 0
Poland
Date submitted for ethics approval [1] 291802 0
19/09/2014
Approval date [1] 291802 0
02/10/2014
Ethics approval number [1] 291802 0

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

Contacts
Principal investigator
Name 52082 0
Dr Elzbieta Skorupska
Address 52082 0
Poznan University of Medical Sciences Fredry 10 61-701 Poznan
Country 52082 0
Poland
Phone 52082 0
+48694398333
Fax 52082 0
Email 52082 0
[email protected]
Contact person for public queries
Name 52083 0
Elzbieta Skorupska
Address 52083 0
Poznan University of Medical Sciences Fredry 10 61-701 Poznan
Country 52083 0
Poland
Phone 52083 0
+48 694 398 333
Fax 52083 0
Email 52083 0
[email protected]
Contact person for scientific queries
Name 52084 0
Elzbieta Skorupska
Address 52084 0
Poznan University of Medical Sciences Fredry 10 61-701 Poznan
Country 52084 0
Poland
Phone 52084 0
+48694398333
Fax 52084 0
Email 52084 0
[email protected]

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