Trigger point related vasomotor response to dry needling in patients with low back pain referred to the leg and healthy volunteers

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001188628
• Date of registration: 12/11/2014
• Prospective Registration: Yes
• Primary sponsor: Poznan University of Medical Sciences
• 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.
• Date of first enrolment: 20/11/2014
• Target sample size: 70
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001188628.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Poland

Contacts

• Name: Dr Elzbieta Skorupska

• Name: Dr Elzbieta Skorupska

Key inclusion & exclusion criteria

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
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.

Age minimum: 20 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Physiotherapy

Musculoskeletal - Other muscular and skeletal disorders

Neurological - Other neurological disorders

low back pain reffered to leg;
low back pain reffered to leg

Intervention(s)

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 co

Primary Outcome(s)

Skin temperature response to dry needling under IRT control of TrPs-positive low back pain radiating down subjects and TrPs-positive healthy volounteers[Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN]

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)[Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN]

Secondary Outcome(s)

Size evaluation of vasomotor response to dry needling under infrared thermovision camera control regarding the presence of active, latent, likely TrPs[Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN]

Skin temperature response to dry needling under IRT control regarding the presence of active, latent, likely TrPs [Baseline, as well as 5 and 10 minutes of DN and six minutes of IRT observations post-DN]

Secondary ID(s)

None

Source(s) of Monetary Support

Poznan University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Poznan University of Medical Sciences