NCT06455423

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 7, 2024

Last Update Submit

June 7, 2024

Conditions

Forward Head PostureThoracic HypomobilityUpper Back Pain

Outcome Measures

Primary Outcomes (5)

  • Upper Back Pain or Discomfort

    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

    Thoracic Kyphosis will be quantified using an inclinometer. A higher score signifies increased Kyphosis.

    3 weeks

  • Thoracic Range of Motion (ROM)

    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

    Forward Head Posture will be quantified via Craniovertebral Angle (CVA). A smaller CVA indicates increased forward head posture.

    3 weeks

  • Functional ability

    Functional ability will be quantified using Spine Functional Index (SFA). A smaller SFA score indicates greater functional ability.

    3 weeks

Study Arms (2)

MAN group

ACTIVE COMPARATOR

the standard MAN group will only receive thoracic manipulation and physical therapy

Procedure: Thoracic ManipulationProcedure: Chin tuck in exercisesProcedure: Thoracic Extension ExerciseProcedure: Scapular Retraction ExercisesDevice: Hot PackDevice: TENS

ELDOA-MAN group

EXPERIMENTAL

The ELDOA-MAN group will receive ELDOA exercises in addition to thoracic manipulation and physical therapy.

Procedure: Thoracic ManipulationProcedure: Chin tuck in exercisesProcedure: Thoracic Extension ExerciseProcedure: Scapular Retraction ExercisesDevice: Hot PackDevice: TENSProcedure: ELDOA

Interventions

Thoracic ManipulationPROCEDURE

Thoracic manipulation will be administered at hypomobile or stiff segments.

ELDOA-MAN groupMAN group
Chin tuck in exercisesPROCEDURE

Chin tuck in exercises

ELDOA-MAN groupMAN group
Thoracic Extension ExercisePROCEDURE

Thoracic Extension Exercise

ELDOA-MAN groupMAN group
Scapular Retraction ExercisesPROCEDURE

Scapular Retraction Exercises

ELDOA-MAN groupMAN group
Hot PackDEVICE

Hot Pack

ELDOA-MAN groupMAN group
TENSDEVICE

Trans Cutaneous Electric Nerve Stimulation (TENS)

ELDOA-MAN groupMAN group
ELDOAPROCEDURE

ELDOA exercises

ELDOA-MAN group

Eligibility Criteria

Age19 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, Pakistan

Location

MeSH Terms

Conditions

Back Pain

Interventions

ExerciseTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaElectric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Samra Batool

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

  • Muhammad Osama

    Foundation University Islamabad

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator will be blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will consist of two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 12, 2024

Study Start

June 15, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)