Cervical RadiculopathyNCT06695312
High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy
A study testing selected exercise program and High Tone Power Therapy in people with Cervical Radiculopathy, run by October 6 University at 1 site in Egypt.
Trial summary
To investigate the Effect of High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy Patients. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- selected exercise program and High Tone Power Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Their ages range from 35 to 50 years.
- Both sex
- With mild to moderate cervical disability according to the neck disability index
- Unilateral cervical radiculopathy for more than 6 months.
- Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
- Normal body mass index (18.5 - 24.99Kg/m2).
Who cannot join
- Any other musculoskeletal disorders of the spine or upper extremity
- Patients with any other Neurological deficits, psychiatric disease Cervical myelopathy, Cognitive problems, vertebral fractures and previous history of spine or cervical surgery.
- Neck pain with vertigo or with bilateral upper limbs referred pain.
- Clinical instability, recent trauma and vertebrobasilar insufficiency.
- Structural abnormalities of the spine, osteoporosis, and spasmodic torticollis.
- Inflammatory or other specific disorders of spina such as ankylosing spondylitis and rheumatoid arthritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October 6 university
Giza, Giza Governorate, 0020
Lama Saad ED Mahmoud, PHD, 01157592636
About this study
Official title: Effect of High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy Patients
To investigate the Effect of High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy Patients.
Read the detailed description
Forty two patients with Cervical Radiculopathy will participate in this study. The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to High Tone Power Therapy, three times per week for four weeks. The evaluation methods are cervical joint position error test, neck disability index, Cervical range of motion (CROM) and visual analogue scale
- Conditions
- Cervical Radiculopathy
- Being tested
- selected exercise program, High Tone Power Therapy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selected exercise programOther
therapeutic ultrasound, Static neck exercise
High Tone Power TherapyDevice
High Tone Power Therapy delivered in cervical region 3 times per week for four weeks
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | the study group received the selected exercise program in addition to High Tone Power Therapy Receives: Other: selected exercise program; Device: High Tone Power Therapy |
| control group | Other | therapeutic ultrasound, Static neck exercise, Receives: Other: selected exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical joint position error test
The subject will be instructed to perform an active head rotation to one side, after which returns back to the neutral or starting head position.
The test will be performed in a 3 trials in each direction
Measured: four weeks
Neck disability index
includes 10 items as follows: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation, with a score (0:5) for every point. The maximum score is 50, with the interpretation scoring (no disability = 0: 4, mild disability 5:14, moderate disability 15:24, severe disability 25: 34 and complete disability above 34
Measured: four weeks
CROM
Cervical range of motion measured using CROM in different directions
Measured: four weeks
Secondary outcomes (1)
Visual analogue scale for pain (VAS-P)
is a method for measuring the intensity of pain on a horizontal straight line of fixed length (10 cm), as the left end of the line showed the greatest pain score \& the right end showed the least pain scores, then the patient was asked to put a mark, on the line according to his/her pain sensation, with a higher score representing the higher level of pain
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 posted19 Nov 2024
- Study start15 Sep 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion15 Dec 2024 (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.
- 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
- 42 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
- NCT06695312
- Sponsor's protocol ID
- P.T.REC/012/0053400
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2024
- Last updated
- 27 Nov 2024
- 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy Patients
- ClinicalTrials.gov ID
- NCT06695312
- Acronym / sponsor ID
- P.T.REC/012/0053400
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 19 Nov 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.
To investigate the Effect of High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy Patients.
Detailed description
Forty two patients with Cervical Radiculopathy will participate in this study. The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to High Tone Power Therapy, three times per week for four weeks. The evaluation methods are cervical joint position error test, neck disability index, Cervical range of motion (CROM) and visual analogue scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Other: selected exercise program, Device: High Tone Power Therapythe study group received the selected exercise program in addition to High Tone Power Therapy |
| control group | Other | Other: selected exercise programtherapeutic ultrasound, Static neck exercise, |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Their ages range from 35 to 50 years.
- Both sex
- With mild to moderate cervical disability according to the neck disability index
- Unilateral cervical radiculopathy for more than 6 months.
- Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
Key exclusion criteria (6 listed)
- Any other musculoskeletal disorders of the spine or upper extremity
- Patients with any other Neurological deficits, psychiatric disease Cervical myelopathy, Cognitive problems, vertebral fractures and previous history of spine or cervical surgery.
- Neck pain with vertigo or with bilateral upper limbs referred pain.
- Clinical instability, recent trauma and vertebrobasilar insufficiency.
- Structural abnormalities of the spine, osteoporosis, and spasmodic torticollis.
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 |
|---|---|---|
| selected exercise programtherapeutic ultrasound, Static neck exercise | Other | control group, study group |
| High Tone Power TherapyHigh Tone Power Therapy delivered in cervical region 3 times per week for four weeks | Device | study group |
Primary outcome
cervical joint position error test
Time frame: four weeks
The subject will be instructed to perform an active head rotation to one side, after which returns back to the neutral or starting head position. The test will be performed in a 3 trials in each direction
Neck disability index
Time frame: four weeks
includes 10 items as follows: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation, with a score (0:5) for every point. The maximum score is 50, with the interpretation scoring (no disability = 0: 4, mild disability 5:14, moderate disability 15:24, severe disability 25: 34 and complete disability above 34
CROM
Time frame: four weeks
Cervical range of motion measured using CROM in different directions
1 secondary outcome
Visual analogue scale for pain (VAS-P)
Time frame: four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selected exercise program and High Tone Power Therapy in people with Cervical Radiculopathy, 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 6 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: looking for participants now, as of the sponsor's last update on 27 Nov 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?
This study is still under way. Results are not available in the source record yet.
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?
cervical joint position error test (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 27 Nov 2024.