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

NCT04950413 | Completed DMC

• 1 other identifier: Nada_MSc
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

General purpose: It was investigate the effect of IASTM and phonophoresis on Tension Type headache. Specific Purpose:

1. 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. 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. 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.

Conditions

Headache; Tension-Type Headache

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Traditional Treatment Arm

ACTIVE COMPARATOR

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

Other: Conventional physical therapy program

IASTM treatment arm

EXPERIMENTAL

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; Other: IASTM by M2t blade

Phonophoresis treatment arm

EXPERIMENTAL

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

Other: Conventional physical therapy program; Device: Phonophoresis

Combined IASTM and phonophoresis treatment arm

EXPERIMENTAL

Combined phonophoresis and M2t Blade

Other: Conventional physical therapy program; Other: IASTM by M2t blade; Device: Phonophoresis

Interventions

Conventional physical therapy program OTHER

Infrared, Exercises, Stretching exercise of Suboccepital muscle

Combined IASTM and phonophoresis treatment arm; IASTM treatment arm; Phonophoresis treatment arm; Traditional Treatment Arm

IASTM by M2t blade 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.

Combined IASTM and phonophoresis treatment arm; IASTM treatment arm

Phonophoresis 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; Phonophoresis treatment arm

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nada Gamal Saad: lead

Study Sites (1)

Outpatient clinic - Faculty of Physical Therapy - Cairo University

Dokki, 12611, Egypt

Location

MeSH Terms

Conditions

Headache; Tension-Type Headache

Interventions

Phonophoresis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Prof Abeer Yamany, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Dr Mariam Omran, Lecturer

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 6, 2021
• Study Start: January 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: May 30, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)