NCT06270563

Brief Summary

The purpose of the study is to compare between the efficacy of high intensity LASER therapy and scapular stabilization exercises on ventilatory functions in forward head posture patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

February 13, 2024

Last Update Submit

February 19, 2024

Conditions

Keywords

High Intensity Laser TherapyScapular Stabilization ExercisesVentilatory FunctionForward Head Posture

Outcome Measures

Primary Outcomes (6)

  • Forced vital capacity (FVC)

    It was assessed by a spirometer before and after treatment. The patient was asked to breath 3 tidal breaths then fully expire, then take a deep inspiration to expire forcefully and rapidly as much as possible through the mouthpiece, the procedure was repeated 3 times and the best record was taken.

    12 weeks

  • Forced expiratory volume at one second (FEV1)

    It was assessed by a spirometer before and after treatment. The patient was asked to breath 3 tidal breaths then fully expire, then take a deep inspiration to expire forcefully and rapidly as much as possible through the mouthpiece, the procedure was repeated 3 times and the best record was taken.

    12 weeks

  • FEV1/FVC

    The ratio between the forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) was calculated before and after treatment.

    12 weeks

  • Maximum voluntary ventilation (MVV)

    It was assessed by a spirometer before and after treatment. The patients were instructed to breathe rapidly and deeply for 15 to 30 seconds, ventilatory volumes were recorded, and the maximal volume achieved over 15 consecutive seconds was expressed in liters per minute.

    12 weeks

  • Craniovertebral angle (CVA)

    It was measured by a specific goniometer that was positioned parallel to the C7 Spinous process and the goniometer's movable arm on the anterior cartilage of the ear. The angle between the movable arm and the perpendicular line passing through the C7 vertebrae was recorded.

    12 weeks

  • Neck Disability Index (NDI)

    It is a ten-item questionnaire that was used to assess disability associated with neck pain and whiplash. There are four items that relate to subjective symptomatology (pain intensity, headache, concentration, sleeping) and six items that relate to activities of daily living (lifting, work, driving, recreation, personal care, reading).

    12 weeks

Secondary Outcomes (4)

  • Upper thoracic chest expansion

    12 weeks

  • Middle thoracic chest expansion

    12 weeks

  • Lower thoracic chest expansion

    12 weeks

  • Visual analogue scale (VAS)

    12 weeks

Study Arms (3)

Group A

ACTIVE COMPARATOR

They received postural advice and traditional exercise treatment (stretching and strengthening exercises) for 3 times per week for 12 weeks.

Other: Postural adviceOther: Traditional exercise treatment

Group B

EXPERIMENTAL

They received postural advice, traditional exercise treatment (stretching and strengthening exercises), and scapular stabilization exercises 3 times per week for 12 weeks.

Other: Postural adviceOther: Traditional exercise treatmentOther: Scapular stabilization exercises

Group C

EXPERIMENTAL

They received postural advice, traditional exercise treatment (stretching and strengthening exercises), and high intensity laser therapy 3 times per week for 12 weeks.

Other: Postural adviceOther: Traditional exercise treatmentOther: High intensity Laser therapy

Interventions

The patients received advice about maintaining good posture when sitting, standing, reading, driving, or lifting; taking breaks; sleeping on back or side with a pillow supporting head/neck; avoiding prolonged phone use; adjusting car seat; reading stand for upright posture; keeping objects close when lifting; and using pillows for support when breastfeeding.

Group AGroup BGroup C

The exercise program included strengthening of deep flexor muscles and shoulder retractors while stretching of cervical extensors and pectoral muscles.

Group AGroup BGroup C

Scapular Stabilization exercise was composed of four exercise programs, including scapula retraction exercise, scapula mobilization exercise, and scapula dynamic stabilization exercise I and II.

Group B

There were two phases in every session, the wavelength is 1064 nm, size of spacer is 60 mm in both phases: Phase I (analgesic phase): the application was made by moving the applicator perpendicular to the skin in continuous circular movements at trigger points detected by acupuncture, power was 8.00 w with a dosage of 5 J/cm2, surface area 50 cm2, frequency 25 HZ, treatment time in this phase was 3 minutes and total energy received at this phase was 250 J. Phase II (bio stimulation): the application was made at the pain inflicting region by using continuous linear movements and prevent static application, The power was 8.00 w with a continuous frequency, dosage of 50 J/cm2, surface area 50 cm2, treatment time in this phase was 5 minutes and the total energy that was delivered to the patient during this phase was 2500 J.

Group C

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages ranged from 30 -40 years.
  • All patients were diagnosed with forward head posture. - Diagnostic criteria for forward head posture by craniovertebral angle that detected by radiography and was less than 49° using specific goniometer.
  • Patients with abnormal values of decreased Forced vital capacity (FVC), forced expiratory volume at one second (FEV1), FEV1/FVC, MVV and TLC due to forward head posture.
  • All patients are medically and psychologically stable
  • They had a score more than 40% at neck disability index.

You may not qualify if:

  • Patients who had congenital anomalies in the neck and the thoracic cage.
  • Patients with pulmonary diseases (with restrictive lung disease or with obstructive lung disease).
  • Patients with BMI \> 30 kg/m2.
  • patients with Contraindications for HILT: malignancies and potential precancerous growths, patients with cochlear implants, endocrine glands disease, patients with febrile conditions, epilepsy, pregnancy, freckles or tattoos, photosensitive medication.
  • Uncontrolled diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

Study Officials

  • Akram A. Sayed, Prof.

    Faculty of physical therapy, Cairo University, Giza, Egypt.

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 21, 2024

Study Start

October 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations