- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06767098
Efficacy of New Ergonomic Device in Non-Specific Neck Pain.
The Effect of Mobile Holder in Treatment of Patients with Non-Specific Neck Pain.
The goal of this clinical trial is to learn if smartphone holder works to treat neck pain in adults. It will also learn about the usability of smartphone holders. The main questions it aims to answer are:
- Does the smartphone holder decrease pain level and improve function in case of neck pain?
- How likely will the participants recommend the holder for their friends?
Researchers will compare adding the holder to the commonly used exercises for neck pain to a group which will receive the common exercise only. To see if the holder can modify neck pain.
Participants will:
- Do the exercise with or without using the holder
- Visit the clinic 3 times per week for a month for receiving exercise
- Keep a diary of their usage for the holder
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Benha, Egypt, 13511
- Outpatient's clinics of the faculty of physical therapy, Benha university
-
Benha, Egypt
- Faculty of Physical Therapy, Benha University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Subject's age ranges from 18-45
- Having neck discomfort symptoms that were triggered by certain neck positions and by palpating the cervical musculature for at least three months
- Smartphones addiction >6hours per day
Exclusion Criteria:
• Pregnancy.
- Neck pain associated with whiplash injuries or trauma
- medical red flag history (such as tumour, fracture, metabolic diseases, rheumatoid arthritis and osteoporosis)
- Neck pain with cervical radiculopathy or neck pain associated with externalized cervical disc herniation.
- If the patient had previous surgery in the neck area (irrespective of the reason for the operation)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: traditional therapeutic exercise for neck pain and smartphone holder
Strech exercise for tight muscles as trapezius and levator scapulae.
strengthening exercises for deep neck flexor and neck extensors.
instructions to use a smartphone holder.
|
strech and strength exercises for neck muscles.
and using smartphone holder daily.
|
|
Active Comparator: traditional therapeutic exercise for neck pain
Strech exercise for tight muscles as trapezius and levator scapulae.
strengthening exercises for deep neck flexor and neck extensors.
|
strech and strength exercises for neck muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain pressure threshold
Time Frame: "From enrollment to the end of treatment at 4 weeks"
|
using algometer
|
"From enrollment to the end of treatment at 4 weeks"
|
|
neck pain intensity
Time Frame: "From enrollment to the end of treatment at 4 weeks"
|
using numeric pain rating scale which compose of 11 points from 0 to 10, while zero indicate no pain and 10 indicates maximum unimaginable pain.
|
"From enrollment to the end of treatment at 4 weeks"
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005574
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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