Cervical PainNCT06491992
Chitosan Phonophresis on Cervical IN Smartphone Addicted Users
A study testing Chitosan Phonophresis and selected physical therapy exercise in people with Cervical Pain, run by October 6 University at 1 site in Egypt.
Trial summary
A phonophoresis-based drug delivery system is a synchronous approach to improve local drug penetration in neuromuscular diseases associated with neuronal damage, excruciating pain, and local inflammation. Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Chitosan Phonophresis and selected physical therapy exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 15 Oct 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 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Their age will be ranged from 16-18 years
- body mass index will be 26.58 kg/m2.
- used a smart phone for more than 1 year for at least 2 hours per day
- complaining of neck pain after using a smart phone, addiction to smart phone in accordance with the smart phone addiction scale (SAS)
Who cannot join
- any previous head and neck injuries or surgeries
- any congenital abnormalities or symptomatic deformity in either the cervical or the lumbar spine
- any uncorrected visual or auditory problems, dizziness, vertigo and headache
- any systematic diseases, any addiction to alcohol, any additive drugs and sedatives within 48 hours previous to tests
- body mass index of subjects over25 kg/m2.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Lama S Mahmoud
Al Jīzah, Select State
Lama S Mahmoud, 01157592636, lamaelsedawyy@hotmail.com
About this study
Official title: Effect of Chitosan Phonophresis on Cervical Pain and Disability in Smartphone Addicted Users
A phonophoresis-based drug delivery system is a synchronous approach to improve local drug penetration in neuromuscular diseases associated with neuronal damage, excruciating pain, and local inflammation. Chitosan, a semi-synthetic material, is obtained by partial deacetylation of chitin amines, resulting in copolymers of N-acetylglucosamine and N-glucosamine. Its use has been explored in various biomaterial and medical applications. Chitosan has emerged as a cost-effective, biocompatible, and biodegradable material with many desirable biological properties, improvement of homeostasis and antiviral potential. Chitosan was found to suppress pro-inflammatory cytokines and decreased peripheral nerve edema, the polycationic nature of chitosan allows it to absorb protons, which reduces inflammation and provides an analgesic effect.
Read the detailed description
The patients will randomly be divided into two equal groups; the control group which will receive the selected exercise program and the study group will receive the same exercise training program in addition to Chitosan Phonophresis, three times per week for four weeks.
- Conditions
- Cervical Pain
- Being tested
- Chitosan Phonophresis, selected physical therapy exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan PhonophresisDrug
Chitosan Phonophresis, three times per week for four weeks.
selected physical therapy exerciseOther
selected neck exercise and electrotherapy on cervical region
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Chitosan Phonophresis intervention Receives: Drug: Chitosan Phonophresis; Other: selected physical therapy exercise |
| control group | Experimental | the selected exercise program Receives: Other: selected physical therapy exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smartphone Addiction Scale-Short Version (SAS-SV)
SAS-SV was psychometrically robust in measuring the severity of smartphone addiction
Measured: four weeks
The visual analogue scale
was utilized to evaluate pre- and post-treatment neck pain
Measured: four weeks
Neck disability index
assess how neck pain and other symptoms manifested during various functional activities. Ndi had been reported as a reliable (Cronbach's alpha: 0.89) and valid instrument to evaluate self-rated disability in patients with neck pain
Measured: four weeks
Secondary outcomes (1)
Cervical ROM
Cervical active ROM will be measured for each participant in the study by digital goniometer device.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491992
- Sponsor's protocol ID
- O6U.PT.REC/024/002003
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- 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 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chitosan Phonophresis on Cervical Pain and Disability in Smartphone Addicted Users
- ClinicalTrials.gov ID
- NCT06491992
- Acronym / sponsor ID
- O6U.PT.REC/024/002003
- Conditions
- Cervical Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 9 Jul 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.
A phonophoresis-based drug delivery system is a synchronous approach to improve local drug penetration in neuromuscular diseases associated with neuronal damage, excruciating pain, and local inflammation. Chitosan, a semi-synthetic material, is obtained by partial deacetylation of chitin amines, resulting in copolymers of N-acetylglucosamine and N-glucosamine. Its use has been explored in various biomaterial and medical applications. Chitosan has emerged as a cost-effective, biocompatible, and biodegradable material with many desirable biological properties, improvement of homeostasis and antiviral potential. Chitosan was found to suppress pro-inflammatory cytokines and decreased peripheral nerve edema, the polycationic nature of chitosan allows it to absorb protons, which reduces inflammation and provides an analgesic effect.
Detailed description
The patients will randomly be divided into two equal groups; the control group which will receive the selected exercise program and the study group will receive the same exercise training program in addition to Chitosan Phonophresis, three times per week for four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Chitosan Phonophresis, Other: selected physical therapy exerciseChitosan Phonophresis intervention |
| control group | Experimental | Other: selected physical therapy exercisethe selected exercise program |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Their age will be ranged from 16-18 years
- body mass index will be 26.58 kg/m2.
- used a smart phone for more than 1 year for at least 2 hours per day
- complaining of neck pain after using a smart phone, addiction to smart phone in accordance with the smart phone addiction scale (SAS)
Key exclusion criteria (5 listed)
- any previous head and neck injuries or surgeries
- any congenital abnormalities or symptomatic deformity in either the cervical or the lumbar spine
- any uncorrected visual or auditory problems, dizziness, vertigo and headache
- any systematic diseases, any addiction to alcohol, any additive drugs and sedatives within 48 hours previous to tests
- body mass index of subjects over25 kg/m2.
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 |
|---|---|---|
| Chitosan PhonophresisChitosan Phonophresis, three times per week for four weeks. | Drug | study group |
| selected physical therapy exerciseselected neck exercise and electrotherapy on cervical region | Other | control group, study group |
Primary outcome
Smartphone Addiction Scale-Short Version (SAS-SV)
Time frame: four weeks
SAS-SV was psychometrically robust in measuring the severity of smartphone addiction
The visual analogue scale
Time frame: four weeks
was utilized to evaluate pre- and post-treatment neck pain
Neck disability index
Time frame: four weeks
assess how neck pain and other symptoms manifested during various functional activities. Ndi had been reported as a reliable (Cronbach's alpha: 0.89) and valid instrument to evaluate self-rated disability in patients with neck pain
1 secondary outcome
Cervical ROM
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan Phonophresis and selected physical therapy exercise in people with Cervical Pain, run by October 6 University at 1 site in Egypt.
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 4 inclusion and 5 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 9 Jul 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 Egypt. 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?
Contact Lama Saad El-Din ED Mahmoud (01157592636, lamaelsedawyy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smartphone Addiction Scale-Short Version (SAS-SV) (time frame: four weeks). The study lists 3 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 9 Jul 2024.