NCT06888609

Brief Summary

To compare the effects of back extensor strengthening exercises versus core stability exercises on thoracic kyphosis in patients, assessing improvements in posture, spinal alignment, and overall functional outcomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 25, 2026

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

February 20, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

PostureSpinal AlignmentOverall Functional OutcomePainRange of Motion

Outcome Measures

Primary Outcomes (5)

  • Change in Pain Intensity Measured by Visual Analogue Scale (VAS)

    A 10 cm horizontal line with "No Pain" (0) on the left and "Worst Pain" (10) on the right. Patients mark their pain level on the scale before and after interventions to assess changes. Test-Retest Reliability: The VAS shows high test-retest reliability, especially in literate populations (r = 0.94), indicating stable pain scores over time when used with the same individual. Validity effectively captures the full spectrum of pain intensity, making it a valid tool for assessing the pain experience of thoracic kyphosis patients.

    12 Weeks

  • Change in Thoracic Spine Range of Motion (ROM) Measured by Inclinometer

    The inclinometer has demonstrated good test-retest reliability, with high correlation (r = 0.90) in measuring range of motion (ROM) over time when used consistently on the same patient.The inclinometer accurately measures thoracic spine mobility and is considered a valid tool for assessing movement restriction or improvement in patients with thoracic kyphosis.

    12 Weeks

  • Assessment of Postural Deformity Severity Using the Matthias Test

    It is effective in identifying postural deformities and the severity of thoracic kyphosis. The Matthias Test has demonstrated good inter-rater reliability.

    12 Weeks

  • Change in Disability Level Measured by Oswestry Disability Index (ODI)

    The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability.

    12 Weeks

  • Change in Functional Disability Measured by Roland-Morris Disability Questionnaire (RDQ)

    The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute, or chronic low back pain.

    12 Weeks

Study Arms (2)

Back Extensor Strengthening Exercises

EXPERIMENTAL

Usage of modalities like hot pack \& TENS along with certain exercises mentioned in the following: 1. Superman Exercise (Prone position, lift chest off ground, arms extended) 2. Prone Arm and Leg Raise (Prone, lift opposite arm \& leg) 3. Seated Row (Resistance Band) (Pull band towards chest) 4. Wall Angels (Standing against wall, moving arms up/down)

Other: Back Extensor Strengthening Exercises

Core Stability Exercises

EXPERIMENTAL

Usage of modalities like hot pack \& TENS along with certain exercises mentioned in the following: 1. Side Plank (Side-lying, lift hips while maintaining straight posture) 2. Dead Bug Exercise (Supine, extend opposite arm \& leg) 3. Bridging Exercise (Supine, lift hips to straight line) 4. Bird-Dog Exercise (Quadruped, extend opposite arm \& leg)

Other: Core Stability Exercises

Interventions

1. Superman Exercise Sets/Reps: 2 sets × 10-12 reps, hold 5-10 sec 2. Prone Arm and Leg Raise Sets/Reps: 2 sets × 10-12 reps, hold 5-10 sec 3. Seated Row (Resistance Band) Sets/Reps: 2 sets × 12-15 reps, hold 3-5 sec 4. Wall Angels Sets/Reps: 2 sets × 10-12 reps, 3-5 sec per cycle

Also known as: Hot Pack (15-20 mins) - Upper back & thoracic spine for relaxation, TENS (10 mins)- Applied to thoracic region for pain relief (Before & after exercises)
Back Extensor Strengthening Exercises

1. Side Plank Sets/Reps: 3 sets, hold 10-60 sec per side 2. Dead Bug Exercise Sets/Reps: 3 sets × 6-15 reps per side 3. Bridging Exercise Sets/Reps: 3 sets × 10-20 reps, hold 2-5 sec 4. Bird-Dog Exercise Sets/Reps: 3 sets × 8-15 reps per side, hold 2-5 sec

Also known as: Hot Pack (15-20 mins) - Upper back & thoracic spine for relaxation, TENS (10 mins)- Applied to thoracic region for pain relief (Before & after exercises)
Core Stability Exercises

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-40 years with a diagnosis of mild to moderate thoracic kyphosis (Cobb angle between 40° and 60°).
  • The presence of back pain or discomfort is attributed to kyphosis.
  • Willingness to participate and commit to the study's duration (6 weeks of intervention and follow-up).
  • Ability to provide informed consent.

You may not qualify if:

  • Severe thoracic kyphosis (Cobb angle \> 60°).
  • Other spinal conditions such as scoliosis or spinal fractures.
  • Previous spinal surgery or contraindications to physical activity.
  • Neurological disorders affecting motor function.
  • Pregnancy or severe medical comorbidities that would preclude participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Timergara & Batkhela

Malakand, KPK, 18300, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve StimulationAnalgesiaLead

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnesthesia and AnalgesiaMetals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Ayesha Sadiq, MSPT (OMPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 21, 2025

Study Start

April 15, 2025

Primary Completion

August 11, 2025

Study Completion

December 31, 2025

Last Updated

February 25, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations