Forward Head PostureNCT06270563
High Intensity Laser Therapy Versus Scapular Stabilization Exercises on Ventilatory Function in Forward Head Posture
A study testing Postural advice, Traditional exercise treatment and Scapular stabilization exercises in people with Forward Head Posture, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Forward Head Posture
- What is being tested?
- Postural advice, Traditional exercise treatment and Scapular stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Neck pain is a common complaint in the population, with a considerable impact on individuals and their families, communities, health-care systems and businesses. The estimated 1-year incidence of neck pain ranges between 10.4 and 21.3%, and the overall prevalence of neck pain in general population can be as high as 86.8%.
The photothermic and the photochemical effects of high intensity LASER therapy may increase blood flow and stimulate collagen production within tendons; in addition, high intensity LASER therapy may increase vascular permeability and has an anti-inflammatory effect, thus removing the pain stimulus.
Scapular stabilization exercise is used as an effective way to recover the imbalance in posture and the muscles. It is also effective in increasing muscle activation in the serratus anterior and lower trapezius, through decreasing the compensatory movement, which is caused by the forward head posture, and in decreasing muscle activation on the upper trapezius. Furthermore, it brings about a spinal curve change and upper crossed syndrome improvement.
Therefore, this study will compare the difference between the effect of high intensity laser therapy and scapular stabilization as a modality of treatment on ventilatory function in forward head posture patients.
- Conditions
- Forward Head Posture
- Being tested
- Postural advice, Traditional exercise treatment, Scapular stabilization exercises, High intensity Laser therapy
- Keywords
- High Intensity Laser Therapy, Scapular Stabilization Exercises, Ventilatory Function, Forward Head Posture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural adviceOther
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.
Traditional exercise treatmentOther
The exercise program included strengthening of deep flexor muscles and shoulder retractors while stretching of cervical extensors and pectoral muscles.
Scapular stabilization exercisesOther
Scapular Stabilization exercise was composed of four exercise programs, including scapula retraction exercise, scapula mobilization exercise, and scapula dynamic stabilization exercise I and II.
High intensity Laser therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | They received postural advice and traditional exercise treatment (stretching and strengthening exercises) for 3 times per week for 12 weeks. Receives: Other: Postural advice; Other: 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. Receives: Other: Postural advice; Other: Traditional exercise treatment; Other: 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. Receives: Other: Postural advice; Other: Traditional exercise treatment; Other: High intensity Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 weeks
Secondary outcomes (4)
Upper thoracic chest expansion
It was measured using a tape measure at the axillary level before and after treatment.
Measured: 12 weeks
Middle thoracic chest expansion
It was measured using a tape measure at the nipple level before and after treatment.
Measured: 12 weeks
Lower thoracic chest expansion
It was measured using a tape measure at the level of the tip of the xiphoid process before and after treatment.
Measured: 12 weeks
Visual analogue scale (VAS)
It was used to assess neck pain intensity; it is graded scale from 10 to 0 at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Oct 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forward Head PostureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa Mohamed Elsadany, Cairo University
- Investigators
- Akram A. Sayed, Prof., Study chair, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270563
- Sponsor's protocol ID
- P.T.REC/012/003967
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Laser Therapy Versus Scapular Stabilization Exercises on Ventilatory Function in Forward Head Posture
- ClinicalTrials.gov ID
- NCT06270563
- Acronym / sponsor ID
- P.T.REC/012/003967
- Conditions
- Forward Head Posture
- Keywords
- High Intensity Laser Therapy, Scapular Stabilization Exercises, Ventilatory Function, Forward Head Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Neck pain is a common complaint in the population, with a considerable impact on individuals and their families, communities, health-care systems and businesses. The estimated 1-year incidence of neck pain ranges between 10.4 and 21.3%, and the overall prevalence of neck pain in general population can be as high as 86.8%.
The photothermic and the photochemical effects of high intensity LASER therapy may increase blood flow and stimulate collagen production within tendons; in addition, high intensity LASER therapy may increase vascular permeability and has an anti-inflammatory effect, thus removing the pain stimulus.
Scapular stabilization exercise is used as an effective way to recover the imbalance in posture and the muscles. It is also effective in increasing muscle activation in the serratus anterior and lower trapezius, through decreasing the compensatory movement, which is caused by the forward head posture, and in decreasing muscle activation on the upper trapezius. Furthermore, it brings about a spinal curve change and upper crossed syndrome improvement.
Therefore, this study will compare the difference between the effect of high intensity laser therapy and scapular stabilization as a modality of treatment on ventilatory function in forward head posture patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Postural advice, Other: Traditional exercise treatmentThey received postural advice and traditional exercise treatment (stretching and strengthening exercises) for 3 times per week for 12 weeks. |
| Group B | Experimental | Other: Postural advice, Other: Traditional exercise treatment, Other: Scapular stabilization exercisesThey received postural advice, traditional exercise treatment (stretching and strengthening exercises), and scapular stabilization exercises 3 times per week for 12 weeks. |
| Group C | Experimental | Other: Postural advice, Other: Traditional exercise treatment, Other: High intensity Laser therapyThey received postural advice, traditional exercise treatment (stretching and strengthening exercises), and high intensity laser therapy 3 times per week for 12 weeks. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postural adviceThe 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. | Other | Group A, Group B, Group C |
| Traditional exercise treatmentThe exercise program included strengthening of deep flexor muscles and shoulder retractors while stretching of cervical extensors and pectoral muscles. | Other | Group A, Group B, Group C |
| Scapular stabilization exercisesScapular Stabilization exercise was composed of four exercise programs, including scapula retraction exercise, scapula mobilization exercise, and scapula dynamic stabilization exercise I and II. | Other | Group B |
| High intensity Laser therapyThere 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. | Other | Group C |
Primary outcome
Forced vital capacity (FVC)
Time frame: 12 weeks
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.
Forced expiratory volume at one second (FEV1)
Time frame: 12 weeks
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.
FEV1/FVC
Time frame: 12 weeks
The ratio between the forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) was calculated before and after treatment.
Maximum voluntary ventilation (MVV)
Time frame: 12 weeks
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.
Craniovertebral angle (CVA)
Time frame: 12 weeks
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.
Neck Disability Index (NDI)
Time frame: 12 weeks
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).
4 secondary outcomes
Upper thoracic chest expansion
Time frame: 12 weeks
Middle thoracic chest expansion
Time frame: 12 weeks
Lower thoracic chest expansion
Time frame: 12 weeks
Visual analogue scale (VAS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Forward Head Posture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akram A. Sayed, Prof. study chair
Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural advice, Traditional exercise treatment and Scapular stabilization exercises in people with Forward Head Posture, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (FVC) (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.