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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
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Scientific title
Dry needling vs Instrument Assisted Soft Tissue Mobilizitation in myofascial pain syndrome treatment in the hamstring musculature
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Secondary ID [1]
296526
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None
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Universal Trial Number (UTN)
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Trial acronym
DNVSIASTM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myofascial pain syndrome in hamstring musculature, specifically, in biceps femoris
310307
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Condition category
Condition code
Musculoskeletal
309041
309041
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
312836
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
308000
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Evaluate the changes in the hamstring tightness (composite primary outcome) measuring the range of motion (ROM) of the hip and knee using the goniometer
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Assessment method [1]
308000
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Timepoint [1]
308000
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Just before the intervention, immediately after the intervention, 7 (primary endpoint) and 14 days after the intervention
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Primary outcome [2]
308001
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Evaluate the changes in the pressure pain threshold of myofascial trigger points of biceps femoris by the algometer
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Assessment method [2]
308001
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Timepoint [2]
308001
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Just before the intervention, immediately after the intervention, 7 (primary endpoint) and 14 days after the intervention
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Secondary outcome [1]
353620
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Actively assess the flexibility of the tissues and the knee range of motion (ROM) using the Active Knee Extension test by the goniometer
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Assessment method [1]
353620
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Timepoint [1]
353620
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Just before the intervention, immediately after the intervention, 7 and 14 days after the intervention
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Secondary outcome [2]
353621
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Passively asses the flexibility of the tissues and knee range of motion using the Passive Knee Extension test by the goniometer
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Assessment method [2]
353621
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Timepoint [2]
353621
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Just before the intervention, immediately after the intervention, 7 and 14 days after the intervention
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Secondary outcome [3]
353622
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Actively assess the flexibility of the tissues and the hip range of motion (ROM) using the Active Straight Leg Raise test by the goniometer
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Assessment method [3]
353622
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Timepoint [3]
353622
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Just before the intervention, immediately after the intervention, 7 and 14 days after the intervention
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Secondary outcome [4]
353623
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Passively asses the flexibility of the tissues and hip range of motion using the Passive Straight Leg Raise test by the goniometer
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Assessment method [4]
353623
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Timepoint [4]
353623
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Just before the intervention, immediately after the intervention, 7 and 14 days after the intervention
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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.
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
19/03/2018
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Date of last participant enrolment
Anticipated
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Actual
27/03/2018
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Date of last data collection
Anticipated
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Actual
17/04/2018
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Sample size
Target
16
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Accrual to date
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Final
16
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Recruitment outside Australia
Country [1]
20995
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Spain
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State/province [1]
20995
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Madrid
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Funding & Sponsors
Funding source category [1]
301110
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University
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Name [1]
301110
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Universidad Camilo José Cela
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Address [1]
301110
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Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
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Country [1]
301110
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Spain
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Primary sponsor type
Individual
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Name
Egoitz Lazkano Juaristi
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Address
Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
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Country
Spain
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Secondary sponsor category [1]
300722
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Individual
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Name [1]
300722
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Raquel Delgado Delgado
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Address [1]
300722
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Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
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Country [1]
300722
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Spain
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301860
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Comité de Ética de la Investigación de la Universidad Camilo José Cela (CEl-UCJC)
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Ethics committee address [1]
301860
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Univ. Camilo José Cela, Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
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Ethics committee country [1]
301860
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Spain
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Date submitted for ethics approval [1]
301860
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05/02/2018
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Approval date [1]
301860
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14/03/2018
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Ethics approval number [1]
301860
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Egoitz Lazkano Juaristi
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Address
88350
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Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
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Country
88350
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Spain
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Phone
88350
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+34688603468
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Fax
88350
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Email
88350
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[email protected]
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Contact person for public queries
Name
88351
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Mr Egoitz Lazkano Juaristi
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Address
88351
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Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
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Country
88351
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Spain
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Phone
88351
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+34688603468
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Fax
88351
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Email
88351
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[email protected]
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Contact person for scientific queries
Name
88352
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Mr Egoitz Lazkano Juaristi
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Address
88352
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Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid
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Country
88352
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Spain
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Phone
88352
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+34688603468
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Fax
88352
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Email
88352
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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