NCT05665296

Brief Summary

PURPOSE: To investigate the effect of cervicothoracic mobilization on Craniovertebral angle (CVA), sagittal shoulder angle (SSA), kyphotic angle and pain intensity level in upper crossed syndrome.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

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

December 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

December 16, 2022

Last Update Submit

April 8, 2023

Conditions

Keywords

Forward head postureRounded ShouldersThoracic kyphosisUCSMobilization

Outcome Measures

Primary Outcomes (4)

  • change in Craniovertebral angle (CVA) .

    Craniovertebral angle (CVA) will be measured using Computerized photogrammetry is utilized markers, Digital camera and Kinovea software.

    before treatment,and after eight weeks of treatment.

  • change in Sagittal shoulder angle (SSA).

    Sagittal shoulder angle (SSA) will be measured using Computerized photogrammetry is utilized markers, Digital camera and Kinovea software.

    before treatment,and after eight weeks of treatment.

  • change in thoracic kyphosis angle.

    thoracic kyphosis angle will be measured using the flexicurve ruler

    before treatment,and after eight weeks of treatment.

  • change in pain level

    pain severity will be measured using visual analogue scale Each participant will be asked to put a mark on a 10-cm horizontal line that is marked with 'zero' at one end to indicate no pain and marked with'10' at the other end to indicate maximum pain.

    before treatment,and after eight weeks of treatment.

Study Arms (2)

cervicothoracic mobilization

EXPERIMENTAL

This group will receive cervicothoracic mobilization with comprehensive corrective exercise

Other: cervicothoracic mobilizationOther: CCE

control group: comprehensive corrective exercise (CCE).

ACTIVE COMPARATOR

This group will receive traditional treatment comprehensive corrective exercise (CCE).

Other: CCE

Interventions

Each participant in study group will receive cervicothoracic mobilization (central PA and transverse Grade III or grade IV) with comprehensive corrective exercise. The duration will eight weeks three sessions per week.

cervicothoracic mobilization
CCEOTHER

Each participant will receive comprehensive corrective exercise include three phases: Initial phase -Improvement phase and Maintenance phase. The initial phase exercises progress in frequency and intensity during this phase, as long as participants are able to demonstrate good quality movement. The initial phase duration is 2 weeks and the exercises will be performed for seven sets of 10-s hold . Improvement phase exercises are progressed by considering individual characteristics of each participant and by observing the overload principle and the progression in the number of repetitions of each set during the 4 weeks of the improvement phase. The exercises will be performed from five sets of ten repetitions to six sets of 15 repetitions . Maintenance phase exercises:The exercises are the same as in the improvement phase without any progression in intensity and frequency. The maintenance phase duration is 2 weeks

cervicothoracic mobilizationcontrol group: comprehensive corrective exercise (CCE).

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-50 years .
  • Participants will included if their CVA less than 48° ( SSA less than 52°) , as above these values are considered normal and thoracic kyphosis (with flexicurve angle more than 45 degrees) .
  • Subjects who have weakness in deep neck flexors, serratus anterior, middle and lower trapezius and rhomboid muscles and tightness in upper trapezius, levator scapulae, scalene, posterior neck and suboccipital muscles, pectoralis major and minor and sternocleidomastoid muscles.
  • Subject complaining of this symptom for more than 3mothes.
  • Marking pain intensity score visual analog scale (VAS) ≥3 in neck and shoulder

You may not qualify if:

  • History of surgery or joint diseases of the spine or shoulder.
  • Osteoporosis, or fracture ,cervical instability or any sign those with other contraindications against joint mobilization.
  • Individuals with any cervical condition e.g. radiculopathy, cervical rib, whiplash injury and individuals with any neurological/ condition .
  • History of congenital spinal deformity (congenital scoliosis) .
  • Any malignancy related to soft tissue and joints .
  • Subjects taking analgesics and/or muscle relaxants.
  • pregnancy.
  • Being in weight out of the normal range (18 ≥ BMI ≥ 25).
  • Cognitive impairment and inability to understand the scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Seidi F, Bayattork M, Minoonejad H, Andersen LL, Page P. Comprehensive corrective exercise program improves alignment, muscle activation and movement pattern of men with upper crossed syndrome: randomized controlled trial. Sci Rep. 2020 Nov 26;10(1):20688. doi: 10.1038/s41598-020-77571-4.

    PMID: 33244045BACKGROUND

MeSH Terms

Conditions

Oculocerebral hypopigmentation syndrome type Preus

Study Officials

  • Abeer Yamany, professor

    Professor of physical therapy, Cairo University

    STUDY CHAIR

Central Study Contacts

Reem M El-kaffas, ass lecturer

CONTACT

Abeer Yamany, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of physical therapy-Benha University

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 27, 2022

Study Start

April 1, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

April 11, 2023

Record last verified: 2023-04