Different Methods of Forward Head Posture Correction

September 5, 2022 updated by: Ibrahim Moustafa, University of Sharjah

Different Methods of Forward Head Posture Correction: Does it Matter? A Randomized Controlled Study

The goal of the study is to compare various methods of correcting forward head posture in elderly subjects. In particular, we will contrast two methods: the conventional program, which aims to restore muscle balance, and the Chiropractic BioPhysics (CBP) rehabilitation program, which relies on stretching the viscous and plastic elements of the longitudinal ligament and intervertebral disc in addition to effectively stretching the soft tissue throughout the entire body.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Forward head posture has been shown to be a common postural displacement, with a conservative estimate being 66% of the whole population. It is generally believed that this abnormal posture is associated with the development and persistence of many disorders. There are many strategies to treat forward head posture; the commonly used is traditional exercise program, which aims to restore muscle balance by stretching the short muscles and strengthening the weak ones. The second treatment method is Chiropractic BioPhysics (CBP) rehabilitation program which depend on stretching of the viscous and plastic elements of the longitudinal ligament and intervertebral disc, in addition to effectively stretching the soft tissue through the entire neck area in the direction of the normal head and neck postures as seen with Denneroll traction in addition to mirror image exercise. Up to our knowledge, there is no available studies evaluating the difference between the two forward head correcting methods regarding the amount of head posture correction and the impact of different correction methods on balance. Most important, in the majority of the previous studies which investigated the efficacy of the different posture correction techniques, the subjects were young people. Therefore, the results might not be applicable to all age groups, particularly to the elderly, due to age-related musculoskeletal and physiological changes. Accordingly, the aim of this study is to compare between traditional exercise program and chiropractic biophysics approach in elderly subject .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
    • United Arab Emirate
      • Sharjah, United Arab Emirate, United Arab Emirates, 27272
        • Ibrahim Moustafa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • craniovertebral angle (CVA) is less than 50°

Exclusion Criteria:

  • any signs or symptoms of medical "red flags" were present: tumor, fracture, rheumatoid arthritis, severe osteoporosis, and prolonged steroid use.
  • Subjects with previous spine surgery
  • Neurological diseases
  • Vascular disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Traditional exercise
The exercise group will receive a posture corrective exercise program in the form of two strengthening(deep cervical flexors and shoulder retractors)and two stretching (cervical extensors and pectoral muscles) exercises. The exercise program will be done according to Harman et al.'s protocol and based on Kendall et al.'s approach.
Other: Posture corrective exercises
The exercises are of two types strengthening exercises and starching exercise ,). The strengthening exercises are to be done for 15 repetitions in 2 sets, Progression will be by increasing to 3 sets and adding 1 Kilogram of resistance in dumbbells exercises, the targeted muscles are teres minor, infraspinatus, medial and lower trapezius, rhomboids, and cervical flexor muscles. On the other hand, stretching exercises are to be hold for 30 seconds for 2 sets then progressed to 3 sets, the targeted muscles are pectoralis minor, sternocleidomastoid and levator scapulae.
EXPERIMENTAL: Denneroll extension traction
Denneroll extension traction. Participants in the intervention group will receive the Denneroll cervical orthotic . In the current study, Denneroll cervical traction will be used to restore the normal cervical alignment. . We will follow previously published protocols and procedures for application of this orthotic. The Denneroll orthotic will be performed in the physiotherapy clinic setting. The participants will be instructed to lie supine on the floor, in a straightened position, with their arms gently folded across their stomach.
Other: Denneroll extension traction
The participants will be instructed to lie supine and keep their legs extended. Based on the apex of each participant's cervical curvature on the initial radiograph, the therapist will position the apex of the denneroll in one of two regions (mid cervical placement or lower cervical placement). The duration of the traction session will start at 2-3 min and increased 1 min per session until reaching the goal of 20 min, the traction will repeated three times per week for 6 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change in craniovertebral angle
Time Frame: will be measured at two intervals ;pre-treatment and immediately after treatment
The craniovertebral angle will be measured by taking a lateral photograph. The participants will be asked to sit on a chair as usual and a lateral photograph will be taken. Adhesive markers will be fixed on the tragus of the ear and the spinous processes of the seventh cervical vertebra. The head forward angle will be measured as an angle between a line drawn from the tragus of the ear to the seventh cervical vertebra and horizontal line
will be measured at two intervals ;pre-treatment and immediately after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change in pain intensity
Time Frame: will be measured at two intervals ;pre-treatment and immediately after treatment
Measurement of pain will be performed by using a visual analogue scale (VAS). The subjects will be asked about the perception of pain using a 10-cm line with 0 (no pain) on one end and 10 (worst pain) on the other. subjects will be asked to place a mark along the line to denote their level of pain
will be measured at two intervals ;pre-treatment and immediately after treatment
The change in Neck Disability Index
Time Frame: will be measured at two intervals ;pre-treatment and immediately after treatment
The Neck Disability Index , consisting of 10 items related to daily living activities.
will be measured at two intervals ;pre-treatment and immediately after treatment
Changes in Cervical joint position sense testing
Time Frame: will be measured at two intervals ;pre-treatment and immediately after treatment
Assessment of head repositioning accuracy with a cervical range of motion (CROM) device will be done according to existing investigations . Participants will be placed in upright neutral seated posture on a stool with no back rest with their feet touching the ground; where their perceived natural head position was determined and used as the reference neutral point. The CROM device will be positioned to 0, 0, 0 for x, y, and z rotational displacements. With their eyes closed, participants will be asked to remember their NHP as the starting posture, andthen actively rotate their head 30° to the left about the vertical y-axis and then reposition their head back the natural head position
will be measured at two intervals ;pre-treatment and immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sharjah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cairo192022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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