Supplemental Effects of ELDOA in Addition to Thoracic Manipulation on Upper Back Pain, Thoracic Kyphosis and Forward Head Posture in Thoracic Hypomobility (ELDOA-MAN)

June 7, 2024 updated by: Foundation University Islamabad

Supplemental Effects of ELDOA in Addition to Thoracic Manipulation on Upper Back Pain, Thoracic Kyphosis and Forward Head Posture in Thoracic Hypomobility (The ELDOA-MAN Study)

The purpose of this study is to determine the supplemental effects of ELDOA in addition to thoracic manipulation on upper back pain, thoracic kyphosis and forward head posture in thoracic hypomobility.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

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
    • Federal
      • Islamabad, Federal, Pakistan
        • Foundation University Islamabad

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

No

Description

Inclusion Criteria:

  • Both male and females
  • Adults (19-44 years)
  • Upper back pain or discomfort
  • Forward head posture
  • Thoracic hypomobility
  • Thoracic hyperkyphosis

Exclusion Criteria:

  • Ankylosing spondylitis
  • History of Spinal Fusion or spinal surgery (discectomy/laminectomy etc.)
  • Degenerative disc disorders, Facet joint syndrome
  • Cervical radiculopathy, Scoliosis
  • Spinal Stenosis or Myelopathy
  • Recent fracture or surgery
  • TB of spine, Spondylolisthesis
  • Not able to attend regular therapy appointments
  • Fibromyalgia/myofascial pain syndrome

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MAN group
the standard MAN group will only receive thoracic manipulation and physical therapy
Procedure: Thoracic Manipulation
Thoracic manipulation will be administered at hypomobile or stiff segments.
Procedure: Chin tuck in exercises
Chin tuck in exercises
Procedure: Thoracic Extension Exercise
Thoracic Extension Exercise
Procedure: Scapular Retraction Exercises
Scapular Retraction Exercises
Device: Hot Pack
Hot Pack
Device: TENS
Trans Cutaneous Electric Nerve Stimulation (TENS)
Experimental: ELDOA-MAN group
The ELDOA-MAN group will receive ELDOA exercises in addition to thoracic manipulation and physical therapy.
Procedure: Thoracic Manipulation
Thoracic manipulation will be administered at hypomobile or stiff segments.
Procedure: Chin tuck in exercises
Chin tuck in exercises
Procedure: Thoracic Extension Exercise
Thoracic Extension Exercise
Procedure: Scapular Retraction Exercises
Scapular Retraction Exercises
Device: Hot Pack
Hot Pack
Device: TENS
Trans Cutaneous Electric Nerve Stimulation (TENS)
Procedure: ELDOA
ELDOA exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Back Pain or Discomfort
Time Frame: 3 weeks
Upper Back Pain or Discomfort will be quantified using Visual Analogue Scale. A higher score signifies greater pain or discomfort on a 0-100mm line.
3 weeks
Thoracic Kyphosis
Time Frame: 3 weeks
Thoracic Kyphosis will be quantified using an inclinometer. A higher score signifies increased Kyphosis.
3 weeks
Thoracic Range of Motion (ROM)
Time Frame: 3 weeks
Thoracic Range of Motion (ROM) will be quantified using an inclinometer. A higher score signifies greater mobility of thoracic spine.
3 weeks
Forward Head Posture
Time Frame: 3 weeks
Forward Head Posture will be quantified via Craniovertebral Angle (CVA). A smaller CVA indicates increased forward head posture.
3 weeks
Functional ability
Time Frame: 3 weeks
Functional ability will be quantified using Spine Functional Index (SFA). A smaller SFA score indicates greater functional ability.
3 weeks

Collaborators and Investigators

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

Sponsor

Foundation University Islamabad

Investigators

  • Study Chair: Muhammad Osama, Foundation University Islamabad
  • Principal Investigator: Samra Batool, Foundation University Islamabad

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 (Estimated)

June 15, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUI/CTR/2024/15

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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