Instrument-assisted Soft Tissue Mobilization and Phonophoresis on Trigger Points of Tension Headache

NCT ID: NCT04950413

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-05-30

Brief Summary

General purpose:

It was investigate the effect of IASTM and phonophoresis on Tension Type headache.

Specific Purpose:

1. It was investigate the effect of IASTM on headache frequency, PPT, pain intensity, and functional disability on trigger points of tension type headache.

2. It was investigate the effect of Lidocaine phonophoresis on headache frequency, PPT, pain intensity and functional disability on trigger points of tension type headache.

3. It was investigate the effect of IASTM and Lidocaine phonophoresis on headache frequency, PPT, pain intensity, and functional disability on trigger points of tension type headache.

Detailed Description

Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug absorption Percutaneous administration offers many benefits such as steady plasma levels, lack of degradation by the gastrointestinal system, and lack of liver effects (first-pass drug metabolism) on drug molecules. Transdermal drug delivery offers a unique opportunity for non-invasive and controlled drug delivery, in contrast to needle-based and oral drug administration. Phonophoresis is a therapeutic method that may be helpful for the treatment of MTP.

There are potentially adverse treatment responses to ISTM that may occur. The patient may experience discomfort during the administration of the treatment, and petechiae (i.e., bruising) may become apparent during or after the treatment Although discomfort may be experienced, patients who have realized a decrease in symptoms have returned repeatedly for additional ISTM sessions other therapeutic modalities should be administered for pain management.

Clinical and scientific evidence supports that proper management of patients with headache should be multimodal including appropriate use of pharmacological and non-pharmacological.IASTM used to facilitate normal alignment of soft tissue and increase fibroblast recruitment and regeneration of damaged tissue. Phonophoresis is frequently used to treat pain associated with muscular disorders, enhancing skin absorption of the topical medication's molecules. Study report that lidocaine decreases sensory input from mrofascialTrps and release local Tenderness by lowering the degree of the reflex mechanism responsible for referred pain.

Conditions

Headache; Tension-Type Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Traditional Treatment Arm

conventional physical therapy program (infrared, stretching exercise, isometric strengthening exercise)

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy program

Intervention Type: OTHER

Infrared, Exercises, Stretching exercise of Suboccepital muscle

IASTM treatment arm

Instrument-assisted soft tissue mobilization (IASTM) is a therapeutic technique that is based on the soft tissue mobilization rationale introduced by James Cyriax.

Group Type: EXPERIMENTAL

Conventional physical therapy program

Intervention Type: OTHER

Infrared, Exercises, Stretching exercise of Suboccepital muscle

IASTM by M2t blade

Intervention Type: OTHER

A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2t blade will be cleaned with an alcohol pad. First, the M2T blade will used to find the exact areas of restriction in affected muscles. Then the M2T blade will use at an angle of 45 to apply slow strokes along the muscle. Changes in soft tissue consistency will detected by the clinician through vibrations of the instrument when it slides on areas of irregular fibrosis of the underneath connective tissue. Once an adhesion is discovered, strokes are repeated for 5 min.

Phonophoresis treatment arm

It will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2.

Group Type: EXPERIMENTAL

Conventional physical therapy program

Intervention Type: OTHER

Infrared, Exercises, Stretching exercise of Suboccepital muscle

Phonophoresis

Intervention Type: DEVICE

It will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2 and. A 5 cm2 crystal head with an effective radiating area of 4.0 cm2 ±1.0 wills utilized for 5 Min for each trigger point of neck. lidocine gelwill applied instead of coupling US gel used for transmission.

Combined IASTM and phonophoresis treatment arm

Combined phonophoresis and M2t Blade

Group Type: EXPERIMENTAL

Conventional physical therapy program

Intervention Type: OTHER

Infrared, Exercises, Stretching exercise of Suboccepital muscle

IASTM by M2t blade

Intervention Type: OTHER

A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2t blade will be cleaned with an alcohol pad. First, the M2T blade will used to find the exact areas of restriction in affected muscles. Then the M2T blade will use at an angle of 45 to apply slow strokes along the muscle. Changes in soft tissue consistency will detected by the clinician through vibrations of the instrument when it slides on areas of irregular fibrosis of the underneath connective tissue. Once an adhesion is discovered, strokes are repeated for 5 min.

Phonophoresis

Intervention Type: DEVICE

It will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2 and. A 5 cm2 crystal head with an effective radiating area of 4.0 cm2 ±1.0 wills utilized for 5 Min for each trigger point of neck. lidocine gelwill applied instead of coupling US gel used for transmission.

Interventions

Conventional physical therapy program

Infrared, Exercises, Stretching exercise of Suboccepital muscle

Intervention Type: OTHER

IASTM by M2t blade

A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2t blade will be cleaned with an alcohol pad. First, the M2T blade will used to find the exact areas of restriction in affected muscles. Then the M2T blade will use at an angle of 45 to apply slow strokes along the muscle. Changes in soft tissue consistency will detected by the clinician through vibrations of the instrument when it slides on areas of irregular fibrosis of the underneath connective tissue. Once an adhesion is discovered, strokes are repeated for 5 min.

Intervention Type: OTHER

Phonophoresis

It will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2 and. A 5 cm2 crystal head with an effective radiating area of 4.0 cm2 ±1.0 wills utilized for 5 Min for each trigger point of neck. lidocine gelwill applied instead of coupling US gel used for transmission.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Their age ranged from 30 to 40 years.
• BMI ranged from 18 to 25 kg /m2.
• TTH criteria according to the Headache Classification Committee of the International Headache Society has at least two of the following characteristics:
• Bilateral location.
• Pressing/tightening quality (non-pulsating).
• Mild or moderate intensity.
• Not aggravated by routine physical activity such as walking or climbing stairs.
• Patients have Trigger points in suboccipital muscle and trigger points 1 trapezius muscle.
• The presence of MTrPs will be determined using the diagnostic criteria described by Simons 1990, in which five major criteria and at least one of three minor criteria are needed for a clinical diagnosis of MPS.

Exclusion Criteria

• Patients with a history of malignancy.
• Patients who had a history of cervical and cranial Surgery.
• Patients with major psychiatric disorders (major Depression).
• Patients with uncontrolled hypertension
• Patient with other causes of headache.
• Dysfunctions in the temporomandibular joint.
• Headaches associated with high fever, stiff neck, or rash, problems with vision, or profound dizziness.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nada Gamal Saad

OTHER

Sponsor Role: lead

Responsible Party

Nada Gamal Saad

Sponsor Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Prof Abeer Yamany, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Dr Mariam Omran, Lecturer

Role: STUDY_DIRECTOR

Cairo University

Locations

Outpatient clinic - Faculty of Physical Therapy - Cairo University

Dokki, , Egypt

Countries

Egypt

Other Identifiers

Nada_MSc

Identifier Type: -

Identifier Source: org_study_id