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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001042437
• Date of registration: 04/08/2016
• Prospective Registration: Yes
• Primary sponsor: School of Physical Therapy, Cairo University
• 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
• Date of first enrolment: 01/10/2016
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001042437.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: A/Prof Mary Kamal Nassif Takla

• Name: A/Prof Mary Kamal Nassif Takla

Key inclusion & exclusion criteria

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.

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.


Age minimum: 25 Years
Age maximum: 45 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Physiotherapy

Mechanical Neck pain;active myofascial trigger points;
Mechanical Neck pain
active myofascial trigger points

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

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 sha

Primary Outcome(s)

pressure pain threshold obtained via an electronic pressure algometer[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(s)

Active cervical range of motion; flexion, extension and side bending with a Smart phone Goniometer application [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 ID(s)

None

Source(s) of Monetary Support

Mary Kamal Nassif Takla

Ethics review

Status: Approved
Approval date:
Contact:

Institutional Review Board of Higher Education and Research of Cairo University

Status: Approved
Approval date:
Contact:

Supreme Council of Universities

Status: Approved
Approval date:
Contact:

The Board Council of Higher Education of the School of Physical Therapy, Cairo university