- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06695312
High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy
November 24, 2024 updated by: Lama Saad El-Din Mahmoud, October 6 University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lama Saad El-Din ED Mahmoud
- Phone Number: 01157592636
- Email: lamaelsedawyy@hotmail.com
Study Locations
-
-
Giza
-
Al Jīzah, Giza, Egypt, 0020
- Recruiting
- October 6 University
-
Contact:
- Lama Saad ED Mahmoud, PHD
- Phone Number: 01157592636
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: study group
the study group received the selected exercise program in addition to High Tone Power Therapy
|
therapeutic ultrasound, Static neck exercise
High Tone Power Therapy delivered in cervical region 3 times per week for four weeks
|
|
Other: control group
therapeutic ultrasound, Static neck exercise,
|
therapeutic ultrasound, Static neck exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
four weeks
|
|
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
|
four weeks
|
|
CROM
Time Frame: four weeks
|
Cervical range of motion measured using CROM in different directions
|
four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale for pain (VAS-P)
Time Frame: four weeks
|
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
|
four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2024
Primary Completion (Estimated)
November 30, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
November 16, 2024
First Submitted That Met QC Criteria
November 16, 2024
First Posted (Actual)
November 19, 2024
Study Record Updates
Last Update Posted (Estimated)
November 27, 2024
Last Update Submitted That Met QC Criteria
November 24, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/0053400
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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