Forward Head PostureELDOA-MANNCT06455423
Supplemental Effects of ELDOA in Addition to Thoracic Manipulation on Upper Back Pain, Thoracic Kyphosis and Forward Head Posture in Thoracic Hypomobility
A study testing Thoracic Manipulation, Chin tuck in exercises and Thoracic Extension Exercise in people with Forward Head Posture and Thoracic Hypomobility, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 44 years
- Conditions the study is for
- Forward Head Posture, Thoracic Hypomobility, Upper Back Pain
- What is being tested?
- Thoracic Manipulation, Chin tuck in exercises and Thoracic Extension Exercise
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2024to 30 Dec 2024
- 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 19 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and females
- Adults (19-44 years)
- Upper back pain or discomfort
- Forward head posture
- Thoracic hypomobility
- Thoracic hyperkyphosis
Who cannot join
- 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
Show all 9Show fewer
- TB of spine, Spondylolisthesis
- Not able to attend regular therapy appointments
- Fibromyalgia/myofascial pain syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Forward Head Posture, Thoracic Hypomobility, Upper Back Pain
- Being tested
- Thoracic Manipulation, Chin tuck in exercises, Thoracic Extension Exercise, Scapular Retraction Exercises, Hot Pack
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic ManipulationProcedure or surgery
Thoracic manipulation will be administered at hypomobile or stiff segments.
Chin tuck in exercisesProcedure or surgery
Chin tuck in exercises
Thoracic Extension ExerciseProcedure or surgery
Thoracic Extension Exercise
Scapular Retraction ExercisesProcedure or surgery
Scapular Retraction Exercises
Hot PackDevice
Hot Pack
TENSDevice
Trans Cutaneous Electric Nerve Stimulation (TENS)
ELDOAProcedure or surgery
ELDOA exercises
| Study group | Role | What they receive |
|---|---|---|
| MAN group | Active comparator | the standard MAN group will only receive thoracic manipulation and physical therapy Receives: Procedure: Thoracic Manipulation; Procedure: Chin tuck in exercises; Procedure: Thoracic Extension Exercise; Procedure: Scapular Retraction Exercises; Device: Hot Pack; Device: TENS |
| ELDOA-MAN group | Experimental | The ELDOA-MAN group will receive ELDOA exercises in addition to thoracic manipulation and physical therapy. Receives: Procedure: Thoracic Manipulation; Procedure: Chin tuck in exercises; Procedure: Thoracic Extension Exercise; Procedure: Scapular Retraction Exercises; Device: Hot Pack; Device: TENS; Procedure: ELDOA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Thoracic Kyphosis
Thoracic Kyphosis will be quantified using an inclinometer. A higher score signifies increased Kyphosis.
Measured: 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.
Measured: 3 weeks
Forward Head Posture
Forward Head Posture will be quantified via Craniovertebral Angle (CVA). A smaller CVA indicates increased forward head posture.
Measured: 3 weeks
Functional ability
Functional ability will be quantified using Spine Functional Index (SFA). A smaller SFA score indicates greater functional ability.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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 Foundation University IslamabadThe 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
- Model description
- The study will consist of two groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samra Batool, Principal investigator, Foundation University IslamabadMuhammad Osama, Study chair, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455423
- Sponsor's protocol ID
- FUI/CTR/2024/15
- Acronym
- ELDOA-MAN
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06455423
- Acronym / sponsor ID
- ELDOA-MAN / FUI/CTR/2024/15
- Conditions
- Forward Head Posture, Thoracic Hypomobility, Upper Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Jun 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study will consist of two groups.
| Arm | Type | Receives |
|---|---|---|
| MAN group | Active comparator | Procedure: Thoracic Manipulation, Procedure: Chin tuck in exercises, Procedure: Thoracic Extension Exercise, Procedure: Scapular Retraction Exercises, Device: Hot Pack, Device: TENSthe standard MAN group will only receive thoracic manipulation and physical therapy |
| ELDOA-MAN group | Experimental | Procedure: Thoracic Manipulation, Procedure: Chin tuck in exercises, Procedure: Thoracic Extension Exercise, Procedure: Scapular Retraction Exercises, Device: Hot Pack, Device: TENS, Procedure: ELDOAThe ELDOA-MAN group will receive ELDOA exercises in addition to thoracic manipulation and physical therapy. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both male and females
- Adults (19-44 years)
- Upper back pain or discomfort
- Forward head posture
- Thoracic hypomobility
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Thoracic ManipulationThoracic manipulation will be administered at hypomobile or stiff segments. | Procedure or surgery | ELDOA-MAN group, MAN group |
| Chin tuck in exercisesChin tuck in exercises | Procedure or surgery | ELDOA-MAN group, MAN group |
| Thoracic Extension ExerciseThoracic Extension Exercise | Procedure or surgery | ELDOA-MAN group, MAN group |
| Scapular Retraction ExercisesScapular Retraction Exercises | Procedure or surgery | ELDOA-MAN group, MAN group |
| Hot PackHot Pack | Device | ELDOA-MAN group, MAN group |
| TENSTrans Cutaneous Electric Nerve Stimulation (TENS) | Device | ELDOA-MAN group, MAN group |
| ELDOAELDOA exercises | Procedure or surgery | ELDOA-MAN group |
Primary outcome
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.
Thoracic Kyphosis
Time frame: 3 weeks
Thoracic Kyphosis will be quantified using an inclinometer. A higher score signifies increased Kyphosis.
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.
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.
Functional ability
Time frame: 3 weeks
Functional ability will be quantified using Spine Functional Index (SFA). A smaller SFA score indicates greater functional ability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Samra Batool principal investigator
Foundation University Islamabad
Muhammad Osama study chair
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Manipulation, Chin tuck in exercises and Thoracic Extension Exercise in people with Forward Head Posture and Thoracic Hypomobility, run by Foundation University Islamabad at 1 site in Pakistan.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Jun 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 Pakistan. 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?
Results are not available in the source record.
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?
Upper Back Pain or Discomfort (time frame: 3 weeks). The study lists 5 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 12 Jun 2024.