Cervical PainNCT04263389
Quantitative Assessment of Shoulder Proprioception in Patients With Chronic Mechanical Cervical Pain
An observational study of Cervical Pain, run by Hamada Ahmed at 1 site in Egypt.
Trial summary
The study was aimed to compare shoulder proprioception in chronic mechanical cervical pain to a matched normal group. This study include 2 groups, 40 subjects with mechanical chronic cervical pain and 40 healthy subjects representing the control group. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Cervical Pain
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 30 Dec 2019
- Phase
- Observational
- 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 20 to 35 years
- All sexes
- Adult
Study population: For the control group they are normal subjects. For the group with cervical pain, participants had a chronic mechanical cervical pain started from three to 12 months with a score of 3 to 65 according to the short-form of the McGill Pain Questionnaire (SF-MPQ).
Who may be able to join
- The age ranged from 20 to 35 years.
- Body Mass Index (BMI) between 18 and less than 30.
- Sufficient cognitive abilities that enables them to understand and follow instructions with a score more than 24 in the Mini-Mental State Examination (MMSE) scale.
- For the group with cervical pain, participants had a chronic mechanical cervical pain started from three to 12 months.
- Participants with chronic pain with a score of 3 to 65 according to the short-form of the McGill Pain Questionnaire (SF-MPQ).
Who cannot join
- Shoulder problems.
- Previous cervical or shoulder surgery.
- Shoulder or cervical trauma.
- Cervical radiculopathy.
- Sever visual and/or auditory problems.
- Cognitive impairment (a score less than 24 according to MMSE).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, Cairo Governorate, 12613
About this study
The study was aimed to compare shoulder proprioception in chronic mechanical cervical pain to a matched normal group. This study include 2 groups, 40 subjects with mechanical chronic cervical pain and 40 healthy subjects representing the control group. The primary outcome measure was the shoulder proprioception test of both upper limbs during active repositioning and quantified with angular displacement error.
Read the detailed description
The study was aimed to compare shoulder proprioception in chronic mechanical cervical pain to a matched normal group. This study include two groups, 40 subjects with mechanical chronic cervical pain and 40 healthy subjects representing the control group. The primary outcome measure was the shoulder proprioception test of both upper limbs during active repositioning and quantified with angular displacement error. Test was applied using an isokinetic dynamometer device at angle 30° for both shoulder internal and external rotation on both sides with an angular velocity 30°/sec.
- Conditions
- Cervical Pain
- Keywords
- chronic mechanical cervical pain, shoulder proprioception,
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control group | control group is a normal matched group. | |
| study group | study group is a group of chronic mechanical cervical pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute angular error (AAE) of shoulder joint
The AAE is an angle that was measured using the isokinetic dynamometer to indicate the sense of position for shoulder joint. Two measurements were performed; AAE for external rotation range and AAE for internal rotation range for both right and left arms.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Apr 2019
- Primary completion15 Nov 2019
- Study completion30 Dec 2019
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamada Ahmed
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Hamada Ahmed, Cairo University
- Investigators
- Wael Shendy, PhD, Study director, Associate professor Faculty of Physical Therapy-Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263389
- Sponsor's protocol ID
- P.T.Rec/012/002078
- Status last verified
- Feb 2020
- First submitted
- 24 Jan 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Shoulder Proprioception in Patients With Chronic Mechanical Cervical Pain
- ClinicalTrials.gov ID
- NCT04263389
- Acronym / sponsor ID
- P.T.Rec/012/002078
- Conditions
- Cervical Pain
- Keywords
- chronic mechanical cervical pain, shoulder proprioception,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hamada AhmedUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 10 Feb 2020 (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.
The study was aimed to compare shoulder proprioception in chronic mechanical cervical pain to a matched normal group. This study include 2 groups, 40 subjects with mechanical chronic cervical pain and 40 healthy subjects representing the control group. The primary outcome measure was the shoulder proprioception test of both upper limbs during active repositioning and quantified with angular displacement error.
Detailed description
The study was aimed to compare shoulder proprioception in chronic mechanical cervical pain to a matched normal group. This study include two groups, 40 subjects with mechanical chronic cervical pain and 40 healthy subjects representing the control group. The primary outcome measure was the shoulder proprioception test of both upper limbs during active repositioning and quantified with angular displacement error. Test was applied using an isokinetic dynamometer device at angle 30° for both shoulder internal and external rotation on both sides with an angular velocity 30°/sec.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –control group is a normal matched group. |
| study group | – | –study group is a group of chronic mechanical cervical pain |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- For the control group they are normal subjects. For the group with cervical pain, participants had a chronic mechanical cervical pain started from three to 12 months with a score of 3 to 65 according to the short-form of the McGill Pain Questionnaire (SF-MPQ).
Key inclusion criteria (5 listed)
- The age ranged from 20 to 35 years.
- Body Mass Index (BMI) between 18 and less than 30.
- Sufficient cognitive abilities that enables them to understand and follow instructions with a score more than 24 in the Mini-Mental State Examination (MMSE) scale.
- For the group with cervical pain, participants had a chronic mechanical cervical pain started from three to 12 months.
- Participants with chronic pain with a score of 3 to 65 according to the short-form of the McGill Pain Questionnaire (SF-MPQ).
Key exclusion criteria (6 listed)
- Shoulder problems.
- Previous cervical or shoulder surgery.
- Shoulder or cervical trauma.
- Cervical radiculopathy.
- Sever visual and/or auditory problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absolute angular error (AAE) of shoulder joint
Time frame: during the procedure
The AAE is an angle that was measured using the isokinetic dynamometer to indicate the sense of position for shoulder joint. Two measurements were performed; AAE for external rotation range and AAE for internal rotation range for both right and left arms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- 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.
Wael Shendy, PhD study director
Associate professor Faculty of Physical Therapy-Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Pain, run by Hamada Ahmed 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute angular error (AAE) of shoulder joint (time frame: during the procedure). 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 22 Jul 2022.