Cervical RadiculopathyNCT06040047
Prediction of Cervical Radiculopathy Success With PNF and Mobilization
A study testing Proprioceptive neuromuscular facilitation and Passive mobilization in people with Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this predictive interventional study is todetrmine clinical predictors for success with combined proprioceptive neuromusclualr faciitaion (PNF) and passive mobilization ain patients with cervical radiculopathy (CR). Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Proprioceptive neuromuscular facilitation and Passive mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 30 Dec 2023
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with cervical radiculopathy.
- Age ranges between 40 and 60 years old.
- Minimum score (3 out of 10-point) on a visual analog scale (VAS)
- Orthopedic clinical confirmation reveals a history of neck pain.
Who cannot join
- Whiplash injury.
- Previous Cervical surgery.
- Pain less than three months.
- Mechanical and non-specific neck pain.
- Pregnancy.
- Bilateral arm pain.
Show all 9Show fewer
- Inflammatory arthritides.
- Osteoporosis.
- Symptoms of vertebrobasilar insufficiency.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
ME
Cairo
ME Shalash, 01115504972, adelmotawea123@gmail.com
About this study
Official title: Identifying Patients With Cervical Radiculopathy Responding to Proprioceptive Neuromuscular Facilitation Exercises Combined With Passive Cervical Mobilization: Clinical Prediction Rule
The goal of this predictive interventional study is todetrmine clinical predictors for success with combined proprioceptive neuromusclualr faciitaion (PNF) and passive mobilization ain patients with cervical radiculopathy (CR).
Read the detailed description
This study will answer the question, what are the factors affecting success with PNF and mobilization for patients with CR? No control group. The goal of this new study is to see the effect of age, duration of symptoms, forward posture angle and neck disability index response to passive mobilization combined with the PNF technique
- Conditions
- Cervical Radiculopathy
- Being tested
- Proprioceptive neuromuscular facilitation, Passive mobilization
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive neuromuscular facilitationOther
Also called PNF
Contract relax technique for each neck motion for three repetitions.
Passive mobilizationOther
To restore normal joint play, postero-anterior passive joint mobilization of cervical spine segments and cervicothoracic junction in limited motion will be applied.
| Study group | Role | What they receive |
|---|---|---|
| PNF plus mobilization | Experimental | This single group will receive passive mobilization and proprioceptive neuromuscular facilitation for cervical region. Receives: Other: Proprioceptive neuromuscular facilitation; Other: Passive mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical pain
Score on numeric pain rating scale (points)
Measured: 6 weeks
Cervical disability
Disability will be measured with Northwick Park neck pain Questionnaire.
Measured: 6 weeks
Secondary outcomes (1)
Cervical proprioception
Cervical joint position error will be measured with laser pointer.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Ahmed ElMelhat, Phd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040047
- Sponsor's protocol ID
- 012/002739
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Patients With Cervical Radiculopathy Responding to Proprioceptive Neuromuscular Facilitation Exercises Combined With Passive Cervical Mobilization: Clinical Prediction Rule
- ClinicalTrials.gov ID
- NCT06040047
- Acronym / sponsor ID
- 012/002739
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 15 Sep 2023 (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 goal of this predictive interventional study is todetrmine clinical predictors for success with combined proprioceptive neuromusclualr faciitaion (PNF) and passive mobilization ain patients with cervical radiculopathy (CR).
Detailed description
This study will answer the question, what are the factors affecting success with PNF and mobilization for patients with CR? No control group. The goal of this new study is to see the effect of age, duration of symptoms, forward posture angle and neck disability index response to passive mobilization combined with the PNF technique
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PNF plus mobilization | Experimental | Other: Proprioceptive neuromuscular facilitation, Other: Passive mobilizationThis single group will receive passive mobilization and proprioceptive neuromuscular facilitation for cervical region. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants with cervical radiculopathy.
- Age ranges between 40 and 60 years old.
- Minimum score (3 out of 10-point) on a visual analog scale (VAS)
- Orthopedic clinical confirmation reveals a history of neck pain.
Key exclusion criteria (9 listed)
- Whiplash injury.
- Previous Cervical surgery.
- Pain less than three months.
- Mechanical and non-specific neck pain.
- Pregnancy.
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 |
|---|---|---|
| Proprioceptive neuromuscular facilitationAlso: PNFContract relax technique for each neck motion for three repetitions. | Other | PNF plus mobilization |
| Passive mobilizationTo restore normal joint play, postero-anterior passive joint mobilization of cervical spine segments and cervicothoracic junction in limited motion will be applied. | Other | PNF plus mobilization |
Primary outcome
Cervical pain
Time frame: 6 weeks
Score on numeric pain rating scale (points)
Cervical disability
Time frame: 6 weeks
Disability will be measured with Northwick Park neck pain Questionnaire.
1 secondary outcome
Cervical proprioception
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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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.
Ahmed ElMelhat, Phd principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive neuromuscular facilitation and Passive mobilization in people with Cervical Radiculopathy, run by Cairo 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 9 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 15 Sep 2023. 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 ElMelhat, PhD (01112595022, ahmedelmelhat@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical pain (time frame: 6 weeks). The study lists 2 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 15 Sep 2023.