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

Primary Purpose

Headache, Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional physical therapy program
IASTM by M2t blade
Phonophoresis
Sponsored by
Nada Gamal Saad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

30 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Outpatient clinic - Faculty of Physical Therapy - Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Traditional Treatment Arm

IASTM treatment arm

Phonophoresis treatment arm

Combined IASTM and phonophoresis treatment arm

Arm Description

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

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

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

Combined phonophoresis and M2t Blade

Outcomes

Primary Outcome Measures

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).
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
June 28, 2021
Last Updated
July 2, 2021
Sponsor
Nada Gamal Saad
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1. Study Identification

Unique Protocol Identification Number
NCT04950413
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nada Gamal Saad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
General purpose: It was investigate the effect of IASTM and phonophoresis on Tension Type headache. Specific Purpose: It was investigate the effect of IASTM on headache frequency, PPT, pain intensity, and functional disability on trigger points of tension type headache. It was investigate the effect of Lidocaine phonophoresis on headache frequency, PPT, pain intensity and functional disability on trigger points of tension type headache. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Tension-Type Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Treatment Arm
Arm Type
Active Comparator
Arm Description
conventional physical therapy program (infrared, stretching exercise, isometric strengthening exercise)
Arm Title
IASTM treatment arm
Arm Type
Experimental
Arm Description
Instrument-assisted soft tissue mobilization (IASTM) is a therapeutic technique that is based on the soft tissue mobilization rationale introduced by James Cyriax.
Arm Title
Phonophoresis treatment arm
Arm Type
Experimental
Arm Description
It will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2.
Arm Title
Combined IASTM and phonophoresis treatment arm
Arm Type
Experimental
Arm Description
Combined phonophoresis and M2t Blade
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy program
Intervention Description
Infrared, Exercises, Stretching exercise of Suboccepital muscle
Intervention Type
Other
Intervention Name(s)
IASTM by M2t blade
Intervention Description
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
Device
Intervention Name(s)
Phonophoresis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessing the change in pain intensity
Description
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).
Time Frame
Baseline and 4 weeks post-intervention
Title
Assessing the change in neck disability
Description
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.
Time Frame
Baseline and 4 weeks post-intervention
Title
Assessing the change in Pain Pressure Threshold
Description
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
Time Frame
Baseline and 4 weeks post-intervention
Title
Assessing the change in frequency of headache
Description
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
Time Frame
Baseline and 4 weeks post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Abeer Yamany, Professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Mariam Omran, Lecturer
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic - Faculty of Physical Therapy - Cairo University
City
Dokki
ZIP/Postal Code
12611
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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