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Trial registered on ANZCTR


Registration number
ACTRN12618001921279
Ethics application status
Approved
Date submitted
13/11/2018
Date registered
26/11/2018
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Date results information initially provided
26/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dry needling vs Instrument Assisted Soft Tissue Mobilizitation in myofascial pain syndrome treatment in the hamstring musculature
Scientific title
Dry needling vs Instrument Assisted Soft Tissue Mobilizitation in myofascial pain syndrome treatment in the hamstring musculature
Secondary ID [1] 296526 0
None
Universal Trial Number (UTN)
Trial acronym
DNVSIASTM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myofascial pain syndrome in hamstring musculature, specifically, in biceps femoris 310307 0
Condition category
Condition code
Musculoskeletal 309041 309041 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Instrument Assited Soft Tissue Mobilization: this treatment will be applied as Graston Tecniche protocol. The treatment must be always supervised by researchers in order to assure the fidelity of the intervention. The subject will be lied in the prone position on the stretcher with a pillow under their ankles so that knees are slightly bent. By palpation, the main investigator will locate two latent or active trigger points in the long head of biceps femoris, that will be the treatment area. First, the investigator will lubricate the treatment area with lotion in order to prevent irritation caused by the friction that may occur when the instrument come in contact with the skin. Afterwards, the handle bar instrument will be placed on the affected area at an angle of 30º to 60º and short sweeping movements will be applied using multi-directional slides. The sliding movements will be from cranial to caudal from the ischial tuberosity to the popliteal fossa. The subjects will be asked to perform isotonic contractions of the biceps femoris by flexing and extending the knee while the sliding movements will be made. Sliding movements will not perform while the biceps femoris is passive. The frequency of the treatment will be once per week and the duration of the treatment will be twice 10-minute session per subject, performing three sliding movements with the concave part and two with the convex part. The number of movements is determined by Instrument Assited Soft Tissue Mobilization Certification manual.
Intervention code [1] 312836 0
Treatment: Other
Comparator / control treatment
Dry Needling: This invasive treatment will be supervised by researchers (physiotherapists) in order to assure the fidelity of the intervention. The subject will be lied in the prone position on the stretcher with a pillow under their ankles and with the knees slightly bent. By palpation, the main investigator will locate two latent or active trigger points in the biceps femoris. The area will be disinfected by Bactiseptic. A 0,30 mm x 50 mm needle from Agupunt will be used at each of the two points, applying the Hong’ rapid multiple needle insertion technique. The needle will be injected until eliciting the first local twitch response confirming that it is the proper locus. Then, the technique will be applied for 30 seconds in each trigger point to elicit the local twitch responses. At the end of the treatment, a cold spray (Medy Spray) will be applied to each subject to relieve post-needling pain. This treatment will be applied once a week during two weeks and the duration of each session will be approximately 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 308000 0
Evaluate the changes in the hamstring tightness (composite primary outcome) measuring the range of motion (ROM) of the hip and knee using the goniometer
Timepoint [1] 308000 0
Just before the intervention, immediately after the intervention, 7 (primary endpoint) and 14 days after the intervention
Primary outcome [2] 308001 0
Evaluate the changes in the pressure pain threshold of myofascial trigger points of biceps femoris by the algometer
Timepoint [2] 308001 0
Just before the intervention, immediately after the intervention, 7 (primary endpoint) and 14 days after the intervention
Secondary outcome [1] 353620 0
Actively assess the flexibility of the tissues and the knee range of motion (ROM) using the Active Knee Extension test by the goniometer
Timepoint [1] 353620 0
Just before the intervention, immediately after the intervention, 7 and 14 days after the intervention
Secondary outcome [2] 353621 0
Passively asses the flexibility of the tissues and knee range of motion using the Passive Knee Extension test by the goniometer
Timepoint [2] 353621 0
Just before the intervention, immediately after the intervention, 7 and 14 days after the intervention
Secondary outcome [3] 353622 0
Actively assess the flexibility of the tissues and the hip range of motion (ROM) using the Active Straight Leg Raise test by the goniometer
Timepoint [3] 353622 0
Just before the intervention, immediately after the intervention, 7 and 14 days after the intervention
Secondary outcome [4] 353623 0
Passively asses the flexibility of the tissues and hip range of motion using the Passive Straight Leg Raise test by the goniometer
Timepoint [4] 353623 0
Just before the intervention, immediately after the intervention, 7 and 14 days after the intervention

Eligibility
Key inclusion criteria
Inclusion criteria will be subjects with at least two myofascial trigger points in the biceps femoris with limitations in knee range of motion in the Active Knee Extension test and in hip range of motion in the Active Straight Leg Raise test. They must be subjects who practice sports at least two days a week with an age between 18-35 years.
Minimum age
18 Years
Maximum age
35 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects presenting the following could not participate in the study: (i) prior treatment of dry needling in the hamstring musculature in the last three months, (ii) phobia treatment or metal allergy, (iii) bleeding disorders, (iv) skin diseases, (v) acute injuries with inflammation and swelling, (vi) surgery or fractures in the lumbo-pelvic region and /or lower limbs, (vii) chronic low back pain, (viii) recent musculoskeletal injury in the lower limbs, (ix) receiving drug treatment in the days before or during the conduct of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This trial use simple randomisation. Participants will be randomly removed, being removed from the rest chosen on envelopes, sealed envelopes with numbers 1 and 2 written. Be so formed two groups: an experimental group 1 (Dry Needling) and an experimental group 2 (Instrument Assisted Soft Tissue Mobilization). Assigning to the Experimental Group 1 (EG1) those subjects who draw a ballot with the number 1, and to the Experimental Group 2 (EG2) those subjects who draw a ballot with the number 2.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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] 20995 0
Spain
State/province [1] 20995 0
Madrid

Funding & Sponsors
Funding source category [1] 301110 0
University
Name [1] 301110 0
Universidad Camilo José Cela
Address [1] 301110 0
Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
Country [1] 301110 0
Spain
Primary sponsor type
Individual
Name
Egoitz Lazkano Juaristi
Address
Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
Country
Spain
Secondary sponsor category [1] 300722 0
Individual
Name [1] 300722 0
Raquel Delgado Delgado
Address [1] 300722 0
Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
Country [1] 300722 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301860 0
Comité de Ética de la Investigación de la Universidad Camilo José Cela (CEl-UCJC)
Ethics committee address [1] 301860 0
Univ. Camilo José Cela, Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
Ethics committee country [1] 301860 0
Spain
Date submitted for ethics approval [1] 301860 0
05/02/2018
Approval date [1] 301860 0
14/03/2018
Ethics approval number [1] 301860 0

Summary
Brief summary
In scientific literature, the most widely used technique for the treatment of myofascial pain syndrome is that known as Dry needling. However, in recent years, a conservative technique called Instrument-assisted soft tissue mobilization has been used for this treatment, which avoids complications and adverse reactions that Dry needling can have. Therefore, the aim of this study is to analyse and compare the effectiveness of an invasive treatment as Dry needling with a non- invasive treatment by Instrument-assisted soft tissue mobilization in the myofascial trigger points of biceps femoris in improving of the symptomatology of the myofascial pain syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88350 0
Mr Egoitz Lazkano Juaristi
Address 88350 0
Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
Country 88350 0
Spain
Phone 88350 0
+34688603468
Fax 88350 0
Email 88350 0
egoitz_4@hotmail.com
Contact person for public queries
Name 88351 0
Mr Egoitz Lazkano Juaristi
Address 88351 0
Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
Country 88351 0
Spain
Phone 88351 0
+34688603468
Fax 88351 0
Email 88351 0
egoitz_4@hotmail.com
Contact person for scientific queries
Name 88352 0
Mr Egoitz Lazkano Juaristi
Address 88352 0
Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
Country 88352 0
Spain
Phone 88352 0
+34688603468
Fax 88352 0
Email 88352 0
egoitz_4@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary