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Trial registered on ANZCTR


Registration number
ACTRN12616001677493
Ethics application status
Approved
Date submitted
8/11/2016
Date registered
6/12/2016
Date last updated
29/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate effects of concurrent application of transcutaneous electrical nerve stimulation (TENS) and Ultrasound phonophoresis on active trigger point tenderness
Scientific title
Immediate effects of combined transcutaneous electrical nerve stimulation (TENS)and ultrasound phonophoresis on active trigger point tenderness in adults with acute mechanical neck pain
Secondary ID [1] 290486 0
'Nil known'
Universal Trial Number (UTN)
U1111-1189-6205
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute mechanical neck pain 300866 0
active-myofascial trigger point (active-MTrP) 300867 0
Condition category
Condition code
Musculoskeletal 300687 300687 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300870 300870 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Therapy is the simultaneous application of electrotherapy and ultrasound (US) at the same time, used as a single modality. One the other hand phonophoresis is the use of ultrasound to enhance the delivery of topically applied drugs. Phonophoresis has been used in an effort to enhance the absorption of topically applied analgesics and anti-inflammatory agents through the therapeutic application of ultrasound.

This study will be conducted at a private clinic located at Heliopolis, Egypt; to compare between the immediate effects of combined therapy phonophoresis, phonophoresis only and US on pressure pain threshold (PPT) and active cervical lateral flexion range of motion (ROM) on upper fibers of trapezius trigger point. To ensure fidelity we explained the entire procedure to the patient; with its aims, and potential unpleasant sensation experience from TENS application and informed him that he has the right to withdraw at anytime during the study duration. 6 free sessions after the completion of the study will be offered to all participants to improve fidelity.

Randomized controlled pre-post experimental design will be used. One hundred patients from both genders will participate in the study after signing institutionally approved consent form prior to data collection. Subjects will be randomly assigned into;

Group A: 25 subjects will receive combined therapy phonophoresis and passive stretch to the upper trapezius trigger point; once for 10 minutes duration.
Group B: 25 subjects will receive phonophoresis and passive stretch to the upper trapezius trigger point; once for 10 minutes duration.
Group C: 25 subjects will receive US and passive stretch to the upper trapezius trigger point; once for 10 minutes duration.
Group D: control group; 25 subjects will receive sham US and passive stretch to the upper trapezius trigger point; once for 10 minutes duration.

A blinded physical therapist with more than 7 years experience will locate, identify and assess tenderness of myofascial trigger points (MTrPs) and active cervical lateral flexion range of motion for all subjects prior to the procedure. Outcome measure will include pressure pain threshold obtained via a digital electronic algometer, as well as active side bending using a smart phone mobile application (Audette et al., 2010 and Tousignant et al., 2006) Data will be collected prior to the application of techniques used as baseline measure and after the application of treatment procedure post-treatment measure.

Clinical identification of active-MTrPs will be based on Travel and Simon (1999) essential criteria, where the upper trapezius will placed in a stretched and relaxed position to easily locate MTrPs. Flat or pincer palpation will be used to locate active-MTrPs.
Essential criteria for active-MTrPs will include; 1- Palpable taut band: palpation for the taut band, which includes a tender nodule. 2- Exquisite spot tenderness of a nodule: Palpating through a taut band, there was a tender nodular area. Digital compression of the nodule may have elicited a referred pain pattern (RPP). 3- Patient pain recognition: Digital compression reproduced pain. Patients usually identify that it is “their usual pain”. Electing the patient’s pain recognition is a strong essential criterion and can discriminate an active MTrP from a latent one. 4- Painful range of motion at the end of range.
He will then mark an "X" on the active-MTrPs found, that are; MTrP1: this central MTrP is found in the mid portion of the anterior border of the upper trapezius and involves the most vertical fibers that attach anteriorly to the clavicle. MTrP2: lies caudal and slightly lateral to MTrP1 which is located in the middle of the more nearly-horizontal fibers of the upper trapezius.
A second physical therapist with more than 5 years experience will carry out the treatment procedure and register attendance at sessions.

a) Combination therapy device
Features of the device: Intelect Advanced color series two channel electrotherapy and combination therapy system will be used in this study; with model number 2752CC (Chattanooga DJO France SAS industries; made in Mexico). It has afFull-color, LCD screen that displays in sharp, vivid detail with main power input of 120-240 VAC- 1.0 A, 50-60 Hz and 175 VA and output of 12 V, 8.3 A

Its assembled with more than 34 medium and low frequency electrical currents
Ultrasound technical specification includes; a frequency of 1 MHz, +/- 5% and 3.3 Mhz, +/-5%; duty cycles of 10%, 20%, 50% and continuous; a pulse repetition rate of 16, 48 or 100 Hz; a pulse duration of 1 mSec, +/- 20%; 2 mSec, +/- 20%; 5 mSec, +/-20%. Its Output Power includes a 5 cm2 crystal with an effective radiating area of 4.0 cm2, +/- 1.0. Its output accuracy is set at +/- 20% above 10% of maximum.

Parameters used;
1- For Combined therapy phonophoresis group: The ultrasound parameters will consist of 1 MHz continuous US set at an intensity of 1.5 W/cm2 and 100Hz repetition rate. Diclofenac sodium 10mg gel will be used instead of coupling US gel used for transmission. The electrical current parameters will include Conventional Transcutaneous electrical nerve stimulation (TENS) that will be set at an asymmetric biphasic waveform; with a phase duration 120 microseconds; cycle time continuous and frequency 150-250 Hz (Weng et al., 2005). Intensity will be increased until the patient feels a strong unpleasant but comfortable sensation. If adaptation occurs the intensity will be raised accordingly.
2- For Phonophoresis group: The ultrasound parameters will consist of 1 MHz continuous US set at an intensity of 1.5 W/cm2 and 100Hz repetition rate. Diclofenac sodium 10mg gel will be used instead of coupling US gel used for transmission.
3- For US group: The ultrasound parameters will consist of 1 MHz continuous US set at an intensity of 1.5 W/cm2 and 100Hz repetition rate. Coupling US gel will be used for transmission.

Another certified physical therapist with 5 years experience will carry out treatment techniques. Combination therapy Phonophoresis application: The subject will be comfortably seated and the muscle will be placed in a slightly stretched position to take up the slack; making it easier to find MTrPs. The dispersive negative electrode of channel two will be placed distal to the active MTrPs; on the deltoid muscle (Loharjun, 2013), while the ultrasound head will act as the positive electrode. After adjusting both electrical current and ultrasound parameters, the intensity will be raised up until the sensory threshold. Diclofenac sodium 10mg gel will be used instead of coupling US gel used for transmission, then circular stroking of ultrasound head over active MTrP1 or 2 of upper fibers of trapezius muscle will be applied throughout the 10 minutes of treatment period. each MTrP will be treated separately for 10 minutes

Same procedure will be applied to Phonophoresis Group and US, but with the parameters stated above.
For the Control group that will receive sham US; the same therapeutic ultrasound machine will be applied as experimental groups but the electrical current during treatment period will be turned-off (Loharjun, 2013)

Passive stretch will be applied directly after the interventions for all groups. With the patient in a seated position; we will stabilize the patient's scapula with one hand pressing laterally and downward on the scapula, while the other hand placed on the side of the head applying the stretching force towards flexion, side bending to the opposite side and rotation to the same side. The stretched position will be sustained for 30 seconds, then a relaxation period of 30 seconds and repeated 3-5 times. Release is augmented by having the patient coordinate downward eye motion and slow exhalation with relaxation. (Simons et al., 1999)
Intervention code [1] 296344 0
Treatment: Devices
Comparator / control treatment
For the Control group that will receive sham US; the same therapeutic ultrasound machine will be applied as experimental groups but the electrical current during treatment period will be turned-off (Loharjun, 2013)
Control group
Placebo

Outcomes
Primary outcome [1] 300107 0
pressure pain threshold obtained via a digital electronic algometer,
Timepoint [1] 300107 0
Data will be collected prior to the application of techniques used as baseline measure and after the application of treatment procedure post-treatment measure
Secondary outcome [1] 329068 0
active cervical lateral flexion range of motion using an iPhone Clinometer (Peter Breitling, Version 3.3) application.
Timepoint [1] 329068 0
Data will be collected prior to the application of techniques used as baseline measure and after the application of treatment procedure post-treatment measure.

Eligibility
Key inclusion criteria
1. Subject’s age will range from 25-45 years old
2. In the initial clinical examination, the subject will have acute mechanical neck pain and will be referred from an orthopedic physician.
3. Subjects will have at least two active MTrPs in the upper trapezius; that corresponds to the same location and physical characteristics of Travel and Simon (1999)
4. Onset of pain of less than 3 months (Tsakitzidis et al., 2013).
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Signs of cervical disc prolapse, radiculopathy, spondylolythesis, systemic disease migraine (Mukkannavar, 2008).
2. Other neurological, orthopedic conditions. (Mukkannavar, 2008)
3. Pregnancy and pacemaker .
4. Onset of pain more than 3 months.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering 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
Age, weight, height will be analyzed statistically by using descriptive statistics to calculate the mean and standard deviation of each group. Multiple-Way ANOVA will be used to compare between 4 groups. The level of significance will be set less than 0.05.

Power analysis will be performed from pervious reported data, based on an estimated 45% increase in PPT after US exposure, with a power of 95%, type 1 error was set at o.o5, mean of 6.9 and 4 with a standard deviation of 2.7. The sample of each group was 25 subjects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2017
Actual
4/01/2017
Date of last participant enrolment
Anticipated
31/01/2017
Actual
15/02/2017
Date of last data collection
Anticipated
31/01/2017
Actual
15/02/2017
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 8379 0
Egypt
State/province [1] 8379 0
Cairo

Funding & Sponsors
Funding source category [1] 294904 0
Self funded/Unfunded
Name [1] 294904 0
Mary Kamal Nassif Takla
Country [1] 294904 0
Egypt
Primary sponsor type
University
Name
School of Physical Therapy, Cairo University
Address
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country
Egypt
Secondary sponsor category [1] 293741 0
None
Name [1] 293741 0
Address [1] 293741 0
Country [1] 293741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296280 0
The Board Council of Higher Education of the School of Physical Therapy, Cairo university
Ethics committee address [1] 296280 0
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Ethics committee country [1] 296280 0
Egypt
Date submitted for ethics approval [1] 296280 0
02/10/2016
Approval date [1] 296280 0
16/10/2016
Ethics approval number [1] 296280 0
Ethics committee name [2] 296281 0
Institutional Review Board of Higher Education and Research of Cairo University
Ethics committee address [2] 296281 0
1 Cairo University Rd, Giza, Giza Governorate. 12613
Ethics committee country [2] 296281 0
Egypt
Date submitted for ethics approval [2] 296281 0
18/10/2015
Approval date [2] 296281 0
23/10/2016
Ethics approval number [2] 296281 0

Summary
Brief summary
Combination Therapy is the simultaneous application of electrotherapy and ultrasound (US) at the same time, used as a single modality. One the other hand phonophoresis is the use of ultrasound to enhance the delivery of topically applied drugs. Phonophoresis has been used in an effort to enhance the absorption of topically applied analgesics and anti-inflammatory agents through the therapeutic application of ultrasound.
This study will be conducted at a private clinic located at Heliopolis, Egypt; to compare between the immediate effects of combined therapy phonophoresis, phonophoresis only and US on pressure pain threshold (PPT) and active cervical lateral flexion range of motion (ROM) on upper fibers of trapezius trigger point.

Randomized controlled pre-post experimental design will be used. One hundred patients from both genders will participate in the study after signing institutionally approved consent form prior to data collection.
Inclusion Criteria:
1. Subject’s age will range from 25-45 years old
2. In the initial clinical examination, the subject will have acute mechanical neck pain and will be referred from an orthopedic physician.
3. Subjects will have at least two active MTrPs in the upper trapezius; that corresponds to the same location and physical characteristics of Travel and Simon (1999)
4. Onset of pain of less than 3 months (Tsakitzidis et al., 2013).

Subjects will be randomly assigned into 4 groups;

Group A: 25 subjects will receive combined therapy phonophoresis and passive stretch to the upper trapezius trigger point; once for 10 minutes duration.
Group B: 25 subjects will receive phonophoresis and passive stretch to the upper trapezius trigger point; once for 10 minutes duration.
Group C: 25 subjects will receive US and passive stretch to the upper trapezius trigger point; once for 10 minutes duration.
Group D: control group; 25 subjects will receive sham US and passive stretch to the upper trapezius trigger point; once for 10 minutes duration.
A blinded physical therapist with more than 7 years experience will locate, identify and assess tenderness of myofascial trigger points (MTrPs) and active cervical lateral flexion range of motion for all subjects prior to the procedure. Outcome measure will include pressure pain threshold obtained via a digital electronic algometer, as well as active side bending using a smart phone mobile application (Audette et al., 2010 and Tousignant et al., 2006) Data will be collected prior to the application of techniques used as baseline measure and after the application of treatment procedure post-treatment measure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70254 0
A/Prof Mary Kamal Nassif Takla
Address 70254 0
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country 70254 0
Egypt
Phone 70254 0
+201222817512
Fax 70254 0
Email 70254 0
marytakla@hotmail.com
Contact person for public queries
Name 70255 0
A/Prof Mary Kamal Nassif Takla
Address 70255 0
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country 70255 0
Egypt
Phone 70255 0
+201222817512
Fax 70255 0
Email 70255 0
marytakla@hotmail.com
Contact person for scientific queries
Name 70256 0
A/Prof Mary Kamal Nassif Takla
Address 70256 0
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country 70256 0
Egypt
Phone 70256 0
+201222817512
Fax 70256 0
Email 70256 0
marytakla@hotmail.com

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