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Trial registered on ANZCTR


Registration number
ACTRN12616001042437
Ethics application status
Approved
Date submitted
31/05/2016
Date registered
4/08/2016
Date last updated
23/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between low & medium frequencies of electrotherapy and ultrasound combined as a single modality in the management of trapezius upper fibers active trigger points
Scientific title
A comparison between low & medium frequencies of electrotherapy and ultrasound combined as a single modality in the management of trapezius upper fibers active trigger points in adults with acute mechanical neck pain
Secondary ID [1] 288956 0
None
Universal Trial Number (UTN)
U1111-1181-7177
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical Neck pain 298329 0
active myofascial trigger points 298330 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298446 298446 0 0
Physiotherapy
Musculoskeletal 299014 299014 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Therapy is the simultaneous application of electrotherapy and ultrasound at the same time, used as a single modality. Electrotherapy used can be low frequency as transcutaneous electrical nerve stimulation (TENS) or medium frequency as amplitude modulated frequency (AMF; the bipolar technique of interferential therapy).

This study will be conducted at a private clinic located at Heliopolis, Egypt; to compare between the effect of medium (interferential current) and low frequency (TENS) combination therapy on the cervical range of motion (ROM) and pressure pain threshold (PPT) on upper fibers of trapezius trigger points. 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. Sixty patients from both gender will participate in the study after signing institutionally approved consent form prior to data collection. Subjects will be randomly assigned into three groups;

Group A: 20 subjects will receive medium frequency (AMF) combination therapy, progressive pressure release and passive stretch to the upper trapezius; 3 times per week for 4 weeks. Session duration will be approximately 30 minutes.

Group B: 20 subjects will receive low frequency (TENS) combination therapy, progressive pressure release and passive stretch to the upper trapezius; 3 times per week for 4 weeks. Session duration will be approximately 30 minutes.

Group C: control group; 20 subjects will receive sham combination therapy, progressive pressure release and passive stretch to the upper trapezius; 3 times per week for 4 weeks. Session duration will be approximately 30 minutes.

A blinded physical therapist with more than 7 years experience will locate, identify and assess tenderness of myofascial trigger points (MTrPs) and 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 flexion/extension and side bending using a smart phone mobile application (Audette et al., 2010 and Tousignant et al., 2006) Data will be collected prior to the first treatment session as baseline measure and at the end of the last treatment session (after 4 weeks) as a post-treatment measure.

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 Neo therapy system will be used in this study; with model number 6001 (Chattanooga DJO industries; made in USA)
It has a Full-colour, 10.4” (26.4 cm) LCD touch screen that displays in sharp, vivid detail
Its Main Power output is 100-240 VAC, 50-60 Hz
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 medium crystal with 0-6W at 1 and 3.3 MHz, and an effective radiating area of 2.0 cm'^2' . Its output accuracy is set at +/- 20%, 10% of maximum.

Parameters used;
The ultrasound parameters will consist of 1 MHz pulsed US with 50% duty cycle and an intensity of 1.2 W/cm'^2' . The electrical current parameters will include;
i) Amplitude modulated frequency (AMF); Interferential therapy at bipolar form; set at a carrier frequency of 4,000 Hz, continuous duty cycle; sweep beat frequency of 80-200 Hz. Intensity will be set at a bearable sensorial threshold for the patient. (Moretti et al., 2012 and Almeida et al., 2003). If adaptation occurs the intensity will be raised accordingly.
ii) Acupuncture like Transcutaneous electrical nerve stimulation (TENS); will be set at an asymmetric biphasic waveform; with a phase duration 400 microseconds; cycle time continuous and frequency 2-10 Hz (Weng et al., 2005). Intensity will be increased until the patient feels a strong unpleasant and uncomfortable sensation, If adaptation occurs the intensity will be raised accordingly.

Combination therapy 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 for AMF current and a strong uncomfortable sensation for the TENS current. Then circular stroking of ultrasound head over active MTrP1 and 2 of upper fibers of trapezius muscle will be applied throughout the 10 minutes of treatment period.
For the Control group that will receive sham combination therapy; the same therapeutic ultrasound machine and the electrode placement will be applied as experimental group but the electrical current during treatment period will be turned-off (Loharjun, 2013)

b) Progressive pressure release technique; using the thumbs, knuckles or four fingers of one or both hands, steady pressure was applied over the MTrP, moving inward toward the center. Once tissue resistance is felt, we will stop and wait until resistance dissipates, and then when a slow release or a “melting away” sensation of the tissue under the treating fingers is felt, further steady pressure moving again inward toward the center will be applied. Once new tissue resistance appears, steady force will be maintained against the tissue, The muscle will placed in a position to maximize stretch, but in a relaxed one. Pressure application will vary in quantity and will start from a few ounces up to a couple of pounds and will be guided by the patient’s pain tolerance, where constant feedback will be provided by the patient. It will applied for at least 30 seconds and up to two (2) minutes at a time and repeated 3-5 times. The patient will breathe deeply and slowly while we progressively increase the pressure (Travell and Simons, 1992).

c) Passive stretch: 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] 294437 0
Treatment: Devices
Intervention code [2] 294888 0
Treatment: Other
Comparator / control treatment
Control group C: will receive sham CT with progressive pressure release and passive stretch, where the machine will be turned on but the intensity will be set to zero
Control group
Placebo

Outcomes
Primary outcome [1] 297933 0
pressure pain threshold obtained via an electronic pressure algometer
Timepoint [1] 297933 0
at the beginning of the 1rst session (baseline measure)
at the end of each session and at the end of the 4 week treatment program
Secondary outcome [1] 322683 0
Active cervical range of motion; flexion, extension and side bending with a Smart phone Goniometer application
Timepoint [1] 322683 0
at the beginning of the 1rst session (baseline measure)
at the end of each session and at the end of the 4 week treatment program

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).
5. Subjects will not have undergone application of any physiotherapy or medications to relieve pain.
Minimum age
25 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Signs of cervical disc prolapse, radiculopathy, spondylolythesis, systemic disease migraine.
2. Other neurological, orthopedic conditions.
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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
G*Power software was used to calculate the sample size, with a power of 0.80, type 1 error was set at o.o5, mean of group A 6.9 and B 4 with a standard deviation of 2.7. The sample of each group was 19, however 20 will be the target of each group.

Age, weight, height will be analyzed statistically by using descriptive statistics to calculate the mean and standard deviation of each group. One-Way ANOVA pairwise 2 side equality will be used to compare between 3 groups. The level of significance will be set less than 0.05.

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] 7796 0
Egypt
State/province [1] 7796 0
Cairo

Funding & Sponsors
Funding source category [1] 293310 0
Self funded/Unfunded
Name [1] 293310 0
Mary Kamal Nassif Takla
Address [1] 293310 0
School of Physical therapy, Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country [1] 293310 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] 292811 0
None
Name [1] 292811 0
Address [1] 292811 0
Country [1] 292811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295157 0
The Board Council of Higher Education of the School of Physical Therapy, Cairo university
Ethics committee address [1] 295157 0
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Ethics committee country [1] 295157 0
Egypt
Date submitted for ethics approval [1] 295157 0
10/05/2016
Approval date [1] 295157 0
20/05/2016
Ethics approval number [1] 295157 0
Ethics committee name [2] 295158 0
Institutional Review Board of Higher Education and Research of Cairo University
Ethics committee address [2] 295158 0
1 Cairo University Rd, Giza, Giza Governorate. 12613
Ethics committee country [2] 295158 0
Egypt
Date submitted for ethics approval [2] 295158 0
22/05/2016
Approval date [2] 295158 0
26/05/2016
Ethics approval number [2] 295158 0
Ethics committee name [3] 295159 0
Supreme Council of Universities
Ethics committee address [3] 295159 0
1 Cairo University Rd, Giza, Giza Governorate 12613
Ethics committee country [3] 295159 0
Egypt
Date submitted for ethics approval [3] 295159 0
22/05/2016
Approval date [3] 295159 0
26/05/2016
Ethics approval number [3] 295159 0

Summary
Brief summary
There is a gap in literature on combination therapy, where no study was conducted to compare the effects of different frequencies (low and medium) of combination therapy. Hence; due to the paucity of research conducted on combination therapy, there is a need to compare between the effects of combination therapy using TENS versus combination therapy using interferential current pain level and ROM of the cervical spine.

Sixty subjects; of both genders will participate in the study. They will be all referred from an orthopedic physician diagnosed with acute mechanical neck dysfunction, with onset of pain of less than 3 months.
Subject’s age will range from 25 to 45 years old
The subject will have mechanical acute neck pain with a minimal of two active MTrPs in the upper trapezius
Subjects will be randomly assigned into three groups;
Group A: 20 subjects will receive medium frequency (IFC) combination therapy, progressive pressure release and passive stretch to the upper trapezius; 3 times per week for 4 weeks
Group B: 20 subjects will receive low frequency (TENS) combination therapy, progressive pressure release and passive stretch to the upper trapezius; 3 times per week for 4 weeks combined therapy
Group C: control group; 20 subjects will receive sham combination therapy, progressive pressure release and passive stretch to the upper trapezius; 3 times per week for 4 weeks
Outcome measure will include pain pressure threshold obtained by an electronic digital algometer, to assess MTrP tenderness.
Data will be collected prior to the first treatment session as a baseline pre-treatment outcome measure, and at the end of the 4 week treatment session as a post-treatment outcome measure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65038 0
A/Prof Mary Kamal Nassif Takla
Address 65038 0
School of Physical therapy, Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country 65038 0
Egypt
Phone 65038 0
+201222817512
Fax 65038 0
Email 65038 0
marytakla@hotmail.com
Contact person for public queries
Name 65039 0
A/Prof Mary Kamal Nassif Takla
Address 65039 0
School of Physical therapy, Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country 65039 0
Egypt
Phone 65039 0
+201222817512
Fax 65039 0
Email 65039 0
marytakla@hotmail.com
Contact person for scientific queries
Name 65040 0
A/Prof Mary Kamal Nassif Takla
Address 65040 0
School of Physical therapy, Cairo university
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country 65040 0
Egypt
Phone 65040 0
+201222817512
Fax 65040 0
Email 65040 0
marytakla@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary