- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06800573
Smartphone Application with Global Postural Re-education in Patients with Upper Cross Syndrome
The Effect of Integrating a Smartphone Application with Global Postural Re-education on Cervical Proprioception in Patients with Upper Cross Syndrome
The Effect of Integrating a Smartphone Application with Global Postural Re-education on Cervical Proprioception in Patients with Upper Cross Syndrome
Design:
Randomized Controlled Trial (RCT).
Procedures:
Patients with cervical pain resulting from Upper Cross Syndrome (UCS), recruited from El Amal Clinic in Fayoum, will be randomly assigned to one of three groups:
Group A: Receives experimental interventions for 50 minutes per day, 4 days per week, over 8 weeks. The exercises are assisted by a smartphone application designed to support the intervention.
Group B: Receives the same interventions as Group A but without the use of the smartphone application. The exercises focus on stretching the anterior and posterior muscle chains.
Control Group: Receives conventional physiotherapy for 50 minutes per day, 4 days per week, over 8 weeks. This includes postural correction, neck education, and exercise therapy.
Inclusion Criteria:
Office workers aged between 28 and 48 years.
Chronic nonspecific neck pain with a Visual Analog Scale (VAS) score between 3 and 8.
Persistent pain for more than 3 months.
Absence of cognitive impairments and the ability to safely participate in an exercise program.
Postural changes characteristic of UCS, such as forward head posture and elevated shoulders.
Exclusion Criteria:
Specific causes of neck pain, such as systemic diseases or neurological signs.
History of spinal surgery or physical therapy treatments within the last 6 months.
Failure to attend three consecutive sessions or four non-consecutive sessions.
Instrumentation:
Assessment Tools:
Visual Analog Scale (VAS) to measure cervical pain.
Cervical Range of Motion (CROM) device to assess cervical range of motion and proprioception.
Neck Disability Index (NDI) to evaluate neck function.
Treatment Tools:
Smartphone application named "Kyphosis and Rounded Back."
Global Postural Reeducation methods.
Traditional physiotherapy techniques.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Effect of Integrating a Smartphone Application with Global Postural Re-education on Cervical Proprioception in Patients with Upper Cross Syndrome
Design:
Randomized Controlled Trial.
Participants:
The sample size will be determined using G power analysis.
Procedures:
Patients of both sexes (men and women) suffering from cervical pain caused by Upper Cross Syndrome (UCS) will be randomly selected from El Amal Clinic in Fayoum. They will be randomly assigned into three groups:
Group A: Participants will undergo experimental interventions for approximately 50 minutes a day, 4 days a week, for an 8-week period. Exercises will be assisted and reminded by a smartphone app at predetermined times.
Group B: Participants will undergo the same experimental interventions for approximately 50 minutes a day, 4 days a week, for an 8-week period, without app assistance. The exercises include:
Exercise 1: The lying posture with leg extension progression, aimed to stretch the anterior muscle chain (diaphragm, pectoralis minor, scalene, sternocleidomastoid, intercostalis, iliopsoas, arm, forearm, and hand flexors).
Exercise 2: The lying posture with flexion of the thighs, intended to stretch the posterior chain (upper trapezius, levator scapulae, suboccipital, erector spinae, gluteus maximus, ischiotibial, triceps surae, and foot intrinsic muscles).
Control Group: Participants will perform an evidence-based physiotherapy program for approximately 50 minutes a day, 4 days a week, for an 8-week period. This program includes:
Postural correction in daily activities, neck education, and exercise therapy focused on issues such as spine anatomy, physiology, biomechanics, common causes of neck pain, the load tolerance model, nociceptive pain processing, self-care, and ergonomic suggestions for daily activities (e.g., standing, sitting, lifting).
Conventional physical therapy, including strengthening exercises for deep neck flexors, rhomboids, lower trapezius, and serratus anterior (2 sets of 10 repetitions per day) and stretching exercises for pectoralis muscles (20-second hold, 5 repetitions).
Inclusion Criteria:
Office workers using a computer for at least 4 hours per day.
Aged between 28 and 48 years.
Neck pain scored between 3 and 8 cm on a Visual Analog Scale (VAS) (0 indicating no pain and 10 indicating unbearable pain).
Chronic nonspecific neck pain lasting more than 3 months.
Willingness and ability to safely participate in an exercise program without cognitive impairments.
Specific postural changes seen in UCS, including forward head posture, increased cervical lordosis and thoracic kyphosis, elevated and protracted shoulders, and scapular rotation, abduction, or winging.
Exclusion Criteria:
Specific causes of neck pain (e.g., systemic, rheumatic, or neuromuscular diseases), central or peripheral neurological signs, cognitive impairments, spinal surgery, or physiotherapy treatments in the 6 months prior to baseline assessment.
Participants missing at least three consecutive or four non-consecutive sessions.
Instrumentation:
For Assessment:
Visual Analog Scale (VAS) to assess cervical pain.
CROM device to assess cervical range of motion (ROM) and cervical proprioception.
Neck Disability Index (NDI) to assess neck function.
For Treatment:
Smartphone app called "Kyphosis and Rounded Back" .
Global Postural Re-education.
Traditional evidence-based physiotherapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kafr El-Sheikh university
- Phone Number: 047 3109590
- Email: rania49.ahmed@gmail.com
Study Contact Backup
- Name: Kafr El-Sheikh university
- Phone Number: 047 3109590
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
office workers(using a computer at least 4 h),
- aged between 28 and 48years,
- NP between 3 and 8 cm on a visual analog scale(VAS) (from 0 indicating no pain at all to 10 indicating unbearable pain),
- Chronic non specific neck pain lasting for more than 3 months (Fathollahnejad et al., 2019).
Exclusion Criteria:
• Specific causes of NP (e.g., systemic, rheumatic, neuromuscular diseases), central or peripheral neurological signs, cognitive impairment, spinal surgery, or physical therapy treatments in the last 6 months prior to the baseline assessment.
- Participants would be also excluded if they missed at least three consecutive or four non consecutive sessions (Fathollahnejad et al., 2019).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: underwent the experimental interventions about 50 min a day, 4 days a week for an 8-week
|
about 50 min a day, 4 days a week for an 8-week period also, performed exercises which were reminded by a smartphone app at predetermined times.
|
|
Experimental: • Group B: underwent the experimental interventions about 50 min a day, 4 days a week for an 8-week
• Group B: underwent the experimental interventions about 50 min a day, 4 days a week for an 8-week period.
|
Exercise 1, the lying posture with leg extension progression, was aimed to stretch the anterior muscle chain (diaphragm, pectoralis minor, scalene, sternocleidomastoid, intercostalis, iliopsoas, arm, forearm, and hand flexors)(Bonetti et al., 2010). Exercise 2, the lying posture with flexion of the thighs, was intended to stretch the posterior chain (upper trapezius, levator scapulae, suboccipital, erector spinae, gluteus maximus, ischiotibial, triceps surae, and foot intrinsic muscles). |
|
Active Comparator: • control group: The participants in the performed an evidence-based physiotherapy program about 50
• control group: The participants in the performed an evidence-based physiotherapy program about 50 min a day, 4 days a week for an 8-week period, described as a postural correction on daily activities .
|
including strengthening exercises for deep neck flexors, rhomboids, lower trapezius and serratus anterior, (2 sets of 10 repetitions per day) and stretching exercises for pectoralis muscles (20seconds hold, 5 repetition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS (visual analogue scale)
Time Frame: 8 weeks
|
1. VAS (visual analogue scale) to assess cervical pain.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical ROM
Time Frame: 8 weeks
|
CROM device to assess cervical ROM and to assess cervical propioception.
|
8 weeks
|
|
Neck disability index (NDI)
Time Frame: 8 weeks
|
Neck disability index (NDI): to assess neck function.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005034
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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