COMPARATIVE EFFECTS OF ELDOA VERSES UPPER THORACIC MOBILIZATION AND MOBILITY EXERCISE FOR THE TREATMENT OF FHP (ELDOA)

May 31, 2024 updated by: Faiza Khalid, University of Faisalabad

COMPARATIVE EFFECTS OF ELONGATION LONGITUDINAUX AVEC DECOAPTION OSTEO ARTICULAIRE VERSUS UPPER THORACIC MOBILIZATION AND MOBILITY EXERCISE FOR THE TREATMENT OF FORWARD HEAD POSTURES

This study will compare the effectiveness of the Elongation Longitudinaux Avec Decoaptation Osteo Articulaire (ELDOA) method and upper thoracic mobilization and mobility exercises in correcting forward head posture (FHP). This study aims to evaluate the effectiveness of these methods in reducing forward head posture. The total sample size will be 36, with each group consisting of 18 participants. This study will be a randomized clinical trial. Participants who meet the inclusion criteria will be selected through screening and then assessed for outcomes using NPRS, a goniometer, the Neck Disability Index (NDI), and Web Plot Digitizer (WPD) Software. Statistical analysis will be conducted using SPSS version 27.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Title Comparative Effectiveness of the ELDOA Method and Upper Thoracic Mobilization and Mobility Exercises in Correcting Forward Head Posture: A Randomized Clinical Trial

Introduction Forward Head Posture (FHP) is a common postural deformity characterized by an anterior positioning of the head relative to the vertical axis of the body. This condition can lead to various musculoskeletal issues, including neck pain, reduced range of motion, and increased disability. The Elongation Longitudinaux Avec Decoaptation Osteo Articulaire (ELDOA) method and upper thoracic mobilization and mobility exercises are two interventions aimed at correcting FHP. This study aims to compare the effectiveness of these two methods in reducing FHP and associated symptoms.

Objectives The primary objective of this study is to evaluate and compare the effectiveness of the ELDOA method and upper thoracic mobilization and mobility exercises in reducing FHP. Secondary objectives include assessing improvements in pain levels, neck disability, and range of motion.

Study Design This study is a randomized clinical trial.

Participants A total of 36 participants will be recruited and randomly assigned to one of two intervention groups, each consisting of 18 participants.

Inclusion Criteria

  • Adults aged 20-40 years
  • Diagnosed with forward head posture
  • Able to provide informed consent
  • No history of recent neck or upper thoracic surgery

Exclusion Criteria

  • Severe musculoskeletal or neurological disorders
  • Recent injury to the neck or upper back
  • Pregnant or breastfeeding women

Interventions Group A (ELDOA Method): Participants will undergo the ELDOA method, which involves specific postural exercises designed to create fascial tension and decompress the spine.

Group B (Upper Thoracic Mobilization and Mobility Exercises)**: Participants will receive upper thoracic mobilization techniques combined with mobility exercises aimed at improving posture and reducing FHP.

Outcome Measures

  1. Numerical Pain Rating Scale (NPRS): To assess the intensity of pain experienced by participants.
  2. Goniometer: To measure the range of motion of the cervical spine.
  3. Neck Disability Index (NDI): To evaluate the level of disability associated with neck pain.
  4. Web Plot Digitizer (WPD) Software : To analyze and quantify postural changes from photographic data.

Procedure

  1. Screening and Baseline Assessment: Participants will be screened for eligibility and baseline measurements will be taken using NPRS, a goniometer, NDI, and WPD.
  2. Randomization: Eligible participants will be randomly assigned to either the ELDOA group or the upper thoracic mobilization and mobility exercises group.
  3. Intervention Period: Both groups will participate in their respective interventions over a period of 8 weeks, with sessions conducted twice a week.
  4. Follow-Up Assessments : Outcomes will be reassessed at the end of the intervention period and compared to baseline values.

Statistical Analysis Data will be analyzed using SPSS version 27. Descriptive statistics will be used to summarize baseline characteristics. Paired t-tests or Wilcoxon signed-rank tests will be used to compare pre- and post-intervention outcomes within groups. Independent t-tests or Mann-Whitney U tests will be employed to compare outcomes between the two groups. A significance level of p < 0.05 will be considered statistically significant.

Expected Outcomes It is hypothesized that both interventions will result in significant improvements in FHP, pain reduction, and decreased neck disability. However, the study aims to determine if one method is superior in achieving these outcomes.

Ethical Considerations This study will adhere to ethical guidelines for clinical research. Informed consent will be obtained from all participants, and the study protocol will be reviewed and approved by an appropriate ethics committee.

Conclusion This randomized clinical trial will provide valuable insights into the comparative effectiveness of the ELDOA method and upper thoracic mobilization and mobility exercises in correcting forward head posture. The findings could inform clinical practice and guide the development of targeted interventions for FHP.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • 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

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 38000
        • Govt Teaching Hospital GM Abad

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Both males and females.
  • Age between 20 to 40 years.
  • Patients having complain of neck pain
  • Patients having forward head posture
  • Patients having limited Cervical range of motion
  • Patients having Craniovertebral angle CVA less than 50.
  • Pain more than 3 on NPRS scale with FHP

Exclusion Criteria:

  • History of whiplash injury within 3 months of examination.
  • History of tumor
  • History of surgery of cervical or thoracic spine.
  • Positive neurological signs
  • Congenital deformity
  • Patients having pathology and infection in spine.
  • Patients having severe osteoporosis

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A will receive ELDOA exercises. At first hot pack will applied for 7-8 minutes after that participants will explain specific body movements. Four ELDOA positions will once shown to the participants then ask them to maintain that positions. Once they make these positions stop watch will be set for one minute for each position. these positions will apply for three times per week for four weeks.
Other: ELDOA ,UPPER THORACIC MOBILIZATION AND MOBILITY EXERCISE
Already mentioned
Experimental: Group-B
Group B will receive the UPPER THORACIC MOBILIZATION AND MOBILITY exercise. At first, a hot pack will be applied for 7-8 minutes after that participants will be in a prone position and the physiotherapist will stand toward the side where mobilization will be applied and the index and middle finger of the left hand of the physiotherapist will be placed on the vertebral transverse processes of the participants to the caudal side. The lateral side of the palm of the right hand will be placed over the left-hand index and middle finger and then thoracic mobilization after that mobility exercise will be performed.
Other: ELDOA ,UPPER THORACIC MOBILIZATION AND MOBILITY EXERCISE
Already mentioned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Craniovertebral angle
Time Frame: 5 Minutes
The primary outcome measure was the CVA, which was calculated using each participant's profile photo. The self-balanced posture assessment method was used to force the participants to maintain their typical head posture. By drawing a vertical line from Targus to the seventh cervical vertebrae and a horizontal line across them, the angle between them may be calculated to determine the CVA angle. The CVA measurement was shown to have excellent reliability in a prior research.
5 Minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical ranges of motion
Time Frame: 20 Minutes
Cervical ranges of motion ( CROM) cervical flexion, extension, right Side bending, left Side bending, right rotation and left rotation were measured using goniometer
20 Minutes
Numeric Pain Rating Scale
Time Frame: 5 Minutes

The NPRS scale, which has good reliability and validity in prior research, was utilized to measure the degree of present pain. 0: No pain

1 - 3: Mild pain 4 - 6: Moderate pain 7 - 10: Severe pain
5 Minutes
Neck disability Index
Time Frame: 10 minutes

The cervical spine's disability index was assessed using the NDI. It consists of 10 items, each scored on a 0 to 5 scale, with the total score ranging from 0 to 50. The NDI score can be expressed as a percentage by multiplying the raw score by 2. The interpretation of the NDI score is typically as follows:

0 - 4 (0% - 8%): No disability 5 - 14 (10% - 28%): Mild disability 15 - 24 (30% - 48%): Moderate disability 25 - 34 (50% - 68%): Severe disability 35 - 50 (70% - 100%): Complete disability
10 minutes

Collaborators and Investigators

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

Sponsor

University of Faisalabad

Investigators

  • Principal Investigator: Faiza Khalid, MSPT, The University of Faisalabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUF/DR/SA/MSPP/2024/380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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