Clinical trial NCT04950413: Instrument-assisted Soft Tissue Mobilization and Phonophoresis on Trigger Points of Tension Headache
Official title: Effect of Instrument-assisted Soft Tissue Mobilization and Phonophoresis on Trigger Points of Tension Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Tension-Type Headache
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessing the change in pain intensity
timeFrame: Baseline and 4 weeks post-intervention
measure: Assessing the change in neck disability
timeFrame: Baseline and 4 weeks post-intervention
measure: Assessing the change in Pain Pressure Threshold
timeFrame: Baseline and 4 weeks post-intervention
measure: Assessing the change in frequency of headache
timeFrame: Baseline and 4 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic - Faculty of Physical Therapy - Cairo University
Study officials:
affiliation: Cairo University
name: Prof Abeer Yamany, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Dr Mariam Omran, Lecturer
role: STUDY_DIRECTOR
References: