High Intensity Laser Therapy Versus Scapular Stabilization Exercises on Ventilatory Function in Forward Head Posture
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 13, 2024
CompletedFirst Posted
Study publicly available on registry
February 21, 2024
CompletedFebruary 21, 2024
February 1, 2024
1.2 years
February 13, 2024
February 19, 2024
Conditions
Keywords
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 COMPARATORThey received postural advice and traditional exercise treatment (stretching and strengthening exercises) for 3 times per week for 12 weeks.
Group B
EXPERIMENTALThey received postural advice, traditional exercise treatment (stretching and strengthening exercises), and scapular stabilization exercises 3 times per week for 12 weeks.
Group C
EXPERIMENTALThey received postural advice, traditional exercise treatment (stretching and strengthening exercises), and high intensity laser therapy 3 times per week for 12 weeks.
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.
The exercise program included strengthening of deep flexor muscles and shoulder retractors while stretching of cervical extensors and pectoral muscles.
Scapular Stabilization exercise was composed of four exercise programs, including scapula retraction exercise, scapula mobilization exercise, and scapula dynamic stabilization exercise I and II.
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.
Eligibility Criteria
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
- Cairo Universitylead
Study Sites (1)
Cairo University
Giza, Egypt
Study Officials
- STUDY CHAIR
Akram A. Sayed, Prof.
Faculty of physical therapy, Cairo University, Giza, Egypt.
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