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

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

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.

Study Overview

• Status: Completed
• Conditions: Headache; Tension-Type Headache
• Intervention / Treatment: Other: Conventional physical therapy program; Other: IASTM by M2t blade; Device: Phonophoresis

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki, Egypt, 12611
    • Outpatient clinic - Faculty of Physical Therapy - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Treatment Arm; conventional physical therapy program (infrared, stretching exercise, isometric strengthening exercise)	Other: Conventional physical therapy program; Infrared, Exercises, Stretching exercise of Suboccepital muscle
Experimental: 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.	Other: Conventional physical therapy program; Infrared, Exercises, Stretching exercise of Suboccepital muscle; 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.
Experimental: Phonophoresis treatment arm; It will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2.	Other: Conventional physical therapy program; Infrared, Exercises, Stretching exercise of Suboccepital muscle; Device: 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.
Experimental: Combined IASTM and phonophoresis treatment arm; Combined phonophoresis and M2t Blade	Other: Conventional physical therapy program; Infrared, Exercises, Stretching exercise of Suboccepital muscle; 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the change in pain intensity	assessment via using visual analogue scale (VAS) most commonly consists of a 100mm horizontal line anchored with two opposite labels; patients mark a score on the scale using a vertical line. A VAS is easy to use and therefore applicable to a variety of practice and research settings. (0 means no pain & 10 means highest pain intensity).	Baseline and 4 weeks post-intervention
Assessing the change in neck disability	assessment via using Neck disability index: The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. 0 points or 0% means: no activity limitations, 50 points or 100% means complete activity limitation,Mean duration of the test: 3 to 7.8 minutes some benchmarks can be found in literature, Vernon and Moir presented the following interpretation: 0-4points (0-8%) no disability. 5-14points (10-28%) mild disability. 15-24points (30-48%) moderate disability. 25-34points (50-64%) severe disability. 35-50points (70-100%) complete disability.	Baseline and 4 weeks post-intervention
Assessing the change in Pain Pressure Threshold	assessment via using Pressure algometer: Pain Pressure Threshold (PPT) was measured by an algometer using a 1 cm2 disk surface area pressed vertically on MTrP. To provoke pain, pressure was increased with a speed of 1kg/cm2/s-1	Baseline and 4 weeks post-intervention
Assessing the change in frequency of headache	Headache frequency assessed after and before 12 sessions. It was defined as the number of headache days per week. The frequency of days with headache in the past weeks was registered by the participant	Baseline and 4 weeks post-intervention

Collaborators and Investigators

• Sponsor: Nada Gamal Saad
• Investigators: Principal Investigator: Prof Abeer Yamany, Professor, Cairo university; Study Director: Dr Mariam Omran, Lecturer, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: Nada_MSc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No