Neck Pain, Posterior Clinical Trial
Official title:
The Effectiveness of Capacitive and Resistive Radiofrequency Therapy Alone or With Manual Therapy in the Treatment of Patients With Chronic Non-specific Mechanical Neck Pain.
Background: Chronic neck pain (CNP) is a major health problem affecting individuals with high prevalence and subsequent complications which interfere with the physical, personnel, and psychological status. The capacitive and resistive radiofrequency therapy (CRRT) is a relatively new treatment modality used in rehabilitation with no evidence on its efficacy on chronic neck pain. Objective: The aim of the present study is to investigate the effect of the CRRT alone or with manual therapy in the treatment of patients with patients with non-specific CNP. Hypotheses Is the application of the CRRT when applied alone or with combination with manual therapy and exercises effective in decreasing pain and improving the function and strength in patients with non-specific chronic neck pain?? Methods: 60 patients will participle in the study. They will be recruited from the hospital in mecca, Saudi Arabia. They will be randomized into three groups. Group I will be treated with stretching exercises (EX) and manual therapy (Manual + EX group). Group II will be treated with CRRT plus exercises (CRRT+ EX group). Group III will be treated by EX plus manual therapy applied during CRRT for groups (Manual + CRRT+ EX group). For groups II and III, capacitive electrodes will be applied for five minutes. Then the resistive electrodes will be applied for 10 minutes and finally the capacitive will be applied again for another five minutes. Assessment of the neck pain, function, CROM, trigger points, neck muscle strength as well as neck angles will be performed. Measurement will be performed before, after 6 weeks, and 6 months of treatment as follow up measurements. Multivariate analysis of variance was used to compare between and within groups. The level of statistical significance is set as P<0.05.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Patients with chronic neck pain. 2. Age is above 18 years. 3. patients had chronic pain = 3 months, 4. The radiological examination showed that the patients is free from any discogenic cause of pain. 5. Patients are willing to stop medications. 6. Patients accepted to assign informed consent to participate in the current study and will attend the lab twice a week for six successive weeks. Exclusion Criteria: 1. They have any known significant medical conditions such as hypertension, asthma, cardiac disease, or systemic disease that adversely affect them during testing. 2. Previous neck surgery/injection for the last six months. 3. Previous vertebral fracture or malignancy. 4. Patients have a discogenic pain or any other radicular manifestation to the upper limb. 5. Unable to commit study requirements. |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Umm Al-Qura University, Faculty of Applied Medical Science | Mecca |
Lead Sponsor | Collaborator |
---|---|
Umm Al-Qura University | Deanship of scientific research at Umm Al-Qura university |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pressure pain threshold | Trigger points in the posterior neck and upper fibers of trapezius muscle will be allocated and evaluated using the pressure algometer. | Measurement will be performed before treatment. | |
Other | Pressure pain threshold | Trigger points in the posterior neck and upper fibers of trapezius muscle will be allocated and evaluated using the pressure algometer. | Measurement will be performed after 6 weeks of treatment. | |
Other | Pressure pain threshold | Trigger points in the posterior neck and upper fibers of trapezius muscle will be allocated and evaluated using the pressure algometer. | Measurement will be performed after 3 months of treatment as a follow up measurement. | |
Other | Pressure pain threshold | Trigger points in the posterior neck and upper fibers of trapezius muscle will be allocated and evaluated using the pressure algometer. | Measurement will be performed after 6 months of treatment as follow up measurement. | |
Primary | Pain intensity | The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line. | Measurement will be performed before treatment. | |
Primary | Pain intensity | The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line. | Measurement will be performed after 6 weeks of treatment. | |
Primary | Pain intensity | The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line. | Measurement will be performed after 3 months of treatment as follow up measurement. | |
Primary | Pain intensity | The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line. | Measurement will be performed after 6 months of treatment as follow up measurement. | |
Secondary | Neck disability index | The level of function is measured by the neck disability index. An Arabic version of neck disability index (NDI) will be filled for all patients. NDI is the most frequently functional activity index used for neck related disabilities and is considered as a valid and reliable measure used in patients with neck pain. NDI is a self-perceived disability neck pain from. Every patient is asked to mark the in each section which most describes his level of disability. Each item is recorded out of 5 for a maximum total score of 50 | Measurement will be performed before treatment. | |
Secondary | Neck disability index | The level of function is measured by the neck disability index. An Arabic version of neck disability index (NDI) will be filled for all patients. NDI is the most frequently functional activity index used for neck related disabilities and is considered as a valid and reliable measure used in patients with neck pain. NDI is a self-perceived disability neck pain from. Every patient is asked to mark the in each section which most describes his level of disability. Each item is recorded out of 5 for a maximum total score of 50 | Measurement will be performed after 6 weeks of treatment. | |
Secondary | Neck disability index | The level of function is measured by the neck disability index. An Arabic version of neck disability index (NDI) will be filled for all patients. NDI is the most frequently functional activity index used for neck related disabilities and is considered as a valid and reliable measure used in patients with neck pain. NDI is a self-perceived disability neck pain from. Every patient is asked to mark the in each section which most describes his level of disability. Each item is recorded out of 5 for a maximum total score of 50 | Measurement will be performed after 3 months of treatment as a follow up measurement. | |
Secondary | Neck disability index | The level of function is measured by the neck disability index. An Arabic version of neck disability index (NDI) will be filled for all patients. NDI is the most frequently functional activity index used for neck related disabilities and is considered as a valid and reliable measure used in patients with neck pain. NDI is a self-perceived disability neck pain from. Every patient is asked to mark the in each section which most describes his level of disability. Each item is recorded out of 5 for a maximum total score of 50 | Measurement will be performed after 6 months of treatment as a follow up measurement. |
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