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Trial registered on ANZCTR


Registration number
ACTRN12617000435381
Ethics application status
Approved
Date submitted
11/01/2017
Date registered
24/03/2017
Date last updated
24/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Manual therapy and electrophysical agents effects on neck muscles in asymptomatic adults.
Scientific title
Immediate effects of manual therapy and combination therapy (Ultrasound and TENS) on upper trapezius latent trigger points in healthy adults.
Secondary ID [1] 290506 0
NIL
Universal Trial Number (UTN)
U1111-1189-6689
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Latent upper trapezius trigger points 300905 0
Condition category
Condition code
Musculoskeletal 300721 300721 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300923 300923 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomly assigned to one of three study groups, (two intervention groups (1 and 3) and one sham group (2)).

Each intervention will be conducted by an experienced physiotherapist, who must establish a priori if a TrP is present in the middle of the more horizontal fibers of the upper trapezius muscle. Therapy will be performed only on this TrP.

Intervention group 1 (Combination therapy group):
Combination therapy will consist in a single session of 90 seconds simultaneous application of US combined with TENS. Subjects will be seated in forward position and resting their arms on a treatment table. Medicarin Megasonic 707 machine will be used.
Parameters for US will be: US continuous mode, 0.2W/cm2, US head 6cm2, with a semi static application on the LTP, with no additional pressure.
Parameters for TENS will be: asymmetrical biphasic waveform, pulse duration 150 microsecond, frequency 100Hz, intensity searching sensitive stimulus with no motor response.

Intervention group 3 (Manual therapy):
Manual intervention will consist on the application of trigger point pressure release plus spray and stretch. The whole intervention will last approximately 10 minutes (2 minutes trigger point pressure release plus 8 minutes spray and stretch.
The trigger point pressure release is performed as a painless but uncomfortable barrier-release technique, applying a perpendicular pressure in the TrP until the patient perceives pain. This pressure is maintained until the pain disappears. At that moment, the pressure is raised again until it reaches a new barrier.
to perform spray and stretch technique the operator should gently lengthen the muscle until it reaches a barrier and then hold that degree of tension. Then, with a vapocoolant spray the operator should apply it over the lenght of the muscle in a series of parallel sweeps in the direction of pain pattern. Sweeps of the spray are extended to cover the referred pain pattern of that muscle. After cooling the muscle, a new stretching position until a new the barrier must be reached. Alternate the application of spray with stretch 3 times.
Intervention code [1] 296520 0
Rehabilitation
Intervention code [2] 296521 0
Treatment: Other
Intervention code [3] 296952 0
Treatment: Devices
Comparator / control treatment
The sham combination therapy will consist in a single session of simulated US and TENS. Subjects will be seated in forward position and resting their arms on a treatment table. Medicarin Megasonic 707 machine will be used. A self-adhesive carbon rubber electrode will be placed on a non-painful area of the contralateral trapezius, avoiding motor points. The US head will be placed on the LTP. The US head will be applied for 90” on the LTP, in semi static mode.
Control group
Placebo

Outcomes
Primary outcome [1] 300337 0
To evaluate pain intensity, a normally innocuous pressure of 2kg/cm2 will be applied on the upper trapezius LTP with an algometer (area 1cm2). The subjects will be asked to indicate their pain on a VAS scale.
Timepoint [1] 300337 0
The measurement will be performed before and immediately after intervention.
Primary outcome [2] 300338 0
To determine Pressure pain threshold variation at the upper trapezius latent trigger points in asymptomatic subjects.
Pressure pain threshold will be measured using an analogue algometer.
Timepoint [2] 300338 0
The measurement will be performed before and immediately after intervention.
Secondary outcome [1] 329730 0
Nil
Timepoint [1] 329730 0
Nil

Eligibility
Key inclusion criteria
Subjects who, without suffering from any other pathology or alteration, present latent trigger points in the upper fibers of the trapezium.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Being physical therapist
- Suffering systemic diseases, history of spinal surgery, vertebral fracture, pelvis fracture or lower limb fracture.
- Suffering from pathological deviation of the spine or other conditions that may cause trigger points
- Presence of cervical and dorsal pain and/or presence of active trigger points
- Patients with any contraindication that prevents the application of electrophysical agents.

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)
There will be a volunteer recruitment campaign, using posters in the University buildings as well as through an email distributed by the university information service.
Those interested in participate in the study will be scheduled for a first interview, which will consist of information about the study, check on compliance with the inclusion and exclusion criteria and signature of informed consent.
Once accepted participation in the study, the volunteer will be registered with a code.
There will be two interventional groups, one formed by patients who are going to receive Combination therapy and the other formed by patients who are going to receive Manual Therapy.
The control group will be formed by patients who are going to receive sham combination therapy
Once registered, volunteers will be allocated to one of the three study groups.
An independent co-worker will allocate the subjects into the three intervention groups by means of sequentially numbered containers. Neither evaluators nor intervention providers will be aware of intervention allocation sequence and group, or the aims of the study, in order to ensure blindness.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of secuence generation will be stratified randomisation with permuted block randomisation.
Factor used for the stratification will be baseline evaluated VAS,
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2017
Actual
10/04/2017
Date of last participant enrolment
Anticipated
Actual
5/05/2017
Date of last data collection
Anticipated
Actual
5/05/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8421 0
Spain
State/province [1] 8421 0
Islas Baleares

Funding & Sponsors
Funding source category [1] 295072 0
University
Name [1] 295072 0
University of the Balearic Islands
Country [1] 295072 0
Spain
Primary sponsor type
Individual
Name
Olga Velasco-Roldan
Address
Universidad de las Islas Baleares.
Edificio Beatriu de Pinos.
Carretera de valldemossa Km 7,5.
07122 Palma de Mallorca
Islas Baleares.
Country
Spain
Secondary sponsor category [1] 293882 0
Individual
Name [1] 293882 0
Iosune Salinas-Bueno
Address [1] 293882 0
Universidad de las Islas Baleares.
Edificio Beatriu de Pinos.
Carretera de valldemossa Km 7,5.
07122 Palma de Mallorca
Islas Baleares.
Country [1] 293882 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296416 0
Comite Etico de Investigacion de las Islas Baleares (CEIC-IB)
Ethics committee address [1] 296416 0
Conselleria de Salut i Consum
Direccion general de evaluacion y acreditacion
Camino de Jesus, 38 A
07011 Palma de Mallorca. Islas Baleares.
Ethics committee country [1] 296416 0
Spain
Date submitted for ethics approval [1] 296416 0
29/02/2016
Approval date [1] 296416 0
27/05/2016
Ethics approval number [1] 296416 0
IB898/07 PI

Summary
Brief summary
Myofascial trigger points are hyperirritable spots located in a taut band of skeletal muscle. Prevalence of this disease in the asymptomatic population is approximately 50%. Several modalities of treatment are used to inactivate trigger points. Not sufficient evidence to show which is the most effective. The aim of this paper was to compare the immediate effects of combination therapy (i.e. US and TENS) with manual therapy (spray and stretch plus trigger point compression) on upper trapezius latent trigger points. Our hypothesis is that combination therapy (US and TENS) is as effective as the gold standard, manual therapy.
Participants will be asymptomatic people with LTP at one side of upper trapezius. After assessed for eligibility and confirmed the participation of the subjects, pain intensity (using a visual analogic scale) and pressure pain threshold (PPT) will evaluated. Subjects will be allocated into three groups: Combination therapy (CT), Manual Therapy (MT) and Sham group. Restricted randomization by blocking will be used: block 1 (evaluated VAS= 3-5), block 2 (evaluated VAS= 5.1-7) and block 3 (evaluated VAS= 7.1-10) as to minimize differences between intervention groups. The patients will be treated for a single session. Visual analogic scale (VAS) and pressure pain threshold (PPT) will be measured immediately after treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70350 0
Dr Iosune Salinas Bueno
Address 70350 0
Universidad de las Islas Baleares. Edificio Beatriu de Pinos. Carretera de valldemossa Km 7,5. 07122 Palma de Mallorca Islas Baleares.
Country 70350 0
Spain
Phone 70350 0
+34971259512
Fax 70350 0
+34971172310
Email 70350 0
[email protected]
Contact person for public queries
Name 70351 0
Olga Velasco-Roldan
Address 70351 0
Universidad de las Islas Baleares. Edificio Beatriu de Pinos. Carretera de valldemossa Km 7,5. 07122 Palma de Mallorca Islas Baleares.
Country 70351 0
Spain
Phone 70351 0
+34971172713
Fax 70351 0
+34971172310
Email 70351 0
[email protected]
Contact person for scientific queries
Name 70352 0
Olga Velasco-Roldan
Address 70352 0
Universidad de las Islas Baleares. Edificio Beatriu de Pinos. Carretera de valldemossa Km 7,5. 07122 Palma de Mallorca Islas Baleares.
Country 70352 0
Spain
Phone 70352 0
+34971172713
Fax 70352 0
+34971172310
Email 70352 0
[email protected]

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