Cervical RadiculopathyNCT06309849
Efficacy of Physical Therapy Intervention in Cervical Angina Patients at Jerash University Office Employees, "Randomized Clinical Trail".
A study testing Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) in people with Cervical Radiculopathy, run by South Valley University.
Trial summary
Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 1 Jun 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- cervical spondylosis, cervical disc, cervical instability
Who cannot join
- Cardiovascular diseases ( ischemic heart disease, heart failure, valvular disease)
About this study
Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Patients with CA may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. Clinicians and patients are unaware that CA symptoms are stemming from cervical spine disorders. However, the mechanism of pain occurrence in patients with CA remains unclear.
Read the detailed description
Randomized Control Trail (RCT) will be used in the study. Participants will be divided into two groups (experimental and control groups). Each group will include 30 participants.
The study population will be employees working in JU from different departments.
A total of 60 participants will be included in the study. Their weight ranged from (50 kilograms) to (100 kilograms). And their height ranged from (150 centimeters) to (190 centimeters). And their body mass index ranged from (22.2) to (27.7). This will be divided into 2 groups with 30 participants in each group.
The data collected will focus on measuring the Range of Motion (ROM) of the cervical spine using an Electro-Goniometer, the pain using Visual Analogue Scale (VAS), and the Hart Rate (HR) using an electro cardio Graphic (ECG).
The study setting will be JU, located in Jerash City, Jordan.
- Conditions
- Cervical Radiculopathy
- Being tested
- Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique)
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique)Other
Also called Strengthening exercises for neck muscles, ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2,
Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) strengthening exercises for neck muscles, ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of Physical Therapy Intervention in Cervical Angina Patients | Experimental | Randomized Control Trail (RCT) will be used in the study. Participants will be dived into experimental group and control group. Each group will includes 30 participants.The physiotherapy program intervention will includes cervical traction, cervical mobilization, Sub occipital release, Muscle energy technique. and ultra sound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2, for study group. Receives: Other: Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) |
| know the effect of Physical Therapy Intervention in Cervical Angina Patients | Placebo comparator | 30 participants in control.The physiotherapy program intervention will include ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2 Receives: Other: Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer.
1- Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using 1-Hart Rate (HR) using Electro Cardiac Graphic (ECG). 2- Blood pressure using Sphygmomanometer.
Measured: Four weeks
Secondary outcomes (1)
3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from (0-10)
3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from ( 0-10)
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start20 Apr 2024 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies 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
- Model description
- Randomized Control Trail (RCT) will be used in the study. Participants will be dived into experimental group and control group. Each group will includes 30 participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Abuzaid, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309849
- Sponsor's protocol ID
- Jerash University
- Status last verified
- Apr 2024
- First submitted
- 10 Feb 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication
Publications
Chien JT, Hsieh MH, Yang CC, Chen IH, Lee RP. Anterior Cervical Discectomy and Fusion Versus Conservative Treatment for Cervical Angina Conservative Treatment. Clin Spine Surg. 2021 Nov 1;34(9):E514-E521. doi: 10.1097/BSD.0000000000001178.
PubMed 33828047
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Physical Therapy Intervention in Cervical Angina Patients at Jerash University Office Employees, "Randomized Clinical Trail".
- ClinicalTrials.gov ID
- NCT06309849
- Acronym / sponsor ID
- Jerash University
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 13 Mar 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.
Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Patients with CA may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. Clinicians and patients are unaware that CA symptoms are stemming from cervical spine disorders. However, the mechanism of pain occurrence in patients with CA remains unclear.
Detailed description
Randomized Control Trail (RCT) will be used in the study. Participants will be divided into two groups (experimental and control groups). Each group will include 30 participants.
The study population will be employees working in JU from different departments.
A total of 60 participants will be included in the study. Their weight ranged from (50 kilograms) to (100 kilograms). And their height ranged from (150 centimeters) to (190 centimeters). And their body mass index ranged from (22.2) to (27.7). This will be divided into 2 groups with 30 participants in each group.
The data collected will focus on measuring the Range of Motion (ROM) of the cervical spine using an Electro-Goniometer, the pain using Visual Analogue Scale (VAS), and the Hart Rate (HR) using an electro cardio Graphic (ECG).
The study setting will be JU, located in Jerash City, Jordan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trail (RCT) will be used in the study. Participants will be dived into experimental group and control group. Each group will includes 30 participants.
| Arm | Type | Receives |
|---|---|---|
| Efficacy of Physical Therapy Intervention in Cervical Angina Patients | Experimental | Other: Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique)Randomized Control Trail (RCT) will be used in the study. Participants will be dived into experimental group and control group. Each group will includes 30 participants.The physiotherapy program intervention will includes cervical traction, cervical mobilization, Sub occipital release, Muscle energy technique. and ultra sound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2, for study group. |
| know the effect of Physical Therapy Intervention in Cervical Angina Patients | Placebo comparator | Other: Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique)30 participants in control.The physiotherapy program intervention will include ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- cervical spondylosis, cervical disc, cervical instability
Key exclusion criteria (1 listed)
- Cardiovascular diseases ( ischemic heart disease, heart failure, valvular disease)
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 |
|---|---|---|
| Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique)Also: Strengthening exercises for neck muscles, ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2,Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) strengthening exercises for neck muscles, ultrasound with parameters 5 min × 3 times × 4 weeks, 1 MHz, continuous: 1.5 W/cm2; pulsed: 2.5 W/cm2. | Other | Efficacy of Physical Therapy Intervention in Cervical Angina Patients, know the effect of Physical Therapy Intervention in Cervical Angina Patients |
Primary outcome
1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer.
Time frame: Four weeks
1- Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using 1-Hart Rate (HR) using Electro Cardiac Graphic (ECG). 2- Blood pressure using Sphygmomanometer.
1 secondary outcome
3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from (0-10)
Time frame: 4 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Results publication: PubMed 33828047Chien JT, Hsieh MH, Yang CC, Chen IH, Lee RP. Anterior Cervical Discectomy and Fusion Versus Conservative Treatment for Cervical Angina Conservative Treatment. Clin Spine Surg. 2021 Nov 1;34(9):E514-E521. doi: 10.1097/BSD.0000000000001178.
- Individual participant dataSharing planned: Yes. After publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) in people with Cervical Radiculopathy, run by South Valley University.
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 1 inclusion and 1 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer. (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309849, which also lists 1 linked publication.
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 8 Apr 2024.