Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05428254
Status:
UNKNOWN
Last Update Posted:
2022-06-23
First Post:
2022-06-12
Brief Title:
Radiofrequency Therapy for Chronic Neck Pain
Sponsor:
Umm Al-Qura University
Organization:
Umm Al-Qura University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 P005
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 P005
Detailed Description:
Chronic neck pain CNP is a major health problem affecting individuals with high prevalence 904 to 868 of the population and comes secondary to low back pain It exerts negative pressure on personnel their families and health organizations in addition to the decreases of workdays and productivity loss CNP may be associated with referred pain restricted range of motion headache presence of trigger points dysfunction of the cervical musculature and presence of faulty posture
Rehabilitation of patients with CNP may include the mechanical electrical and or thermal modalities which are applied with the manual techniques and exercise therapy The capacitive and resistive radiofrequency therapy CRRT is a long-wave diathermy with a long-lasting thermal effect used to decrease pain and muscle spasm in case of lumbago fibromyalgia and knee osteoarthritis
Literature comparing the efficacy of each modality with exercise or with manual therapy Previous literature used CRRT for only its thermal effect The CRRT may combine the effect of thermal electrical and mechanical modalities as well as the effect of exercise and manual therapy with a new technique not used previously This study is the first study using CRRT with a new technique which combines the effect of the CRRT with the manual therapy to treat patients with CNP
Objective of the project
The aim of the present study is to investigate the effect of the CRRT in the treatment of patients with non-specific CNP The CRRT will be applied to the posterior neck and shoulder areas for two sessions per week for six weeks CRRT will be applied alone or combined with manual therapy and stretching exercises
1 To investigate the short-term effect of the CRRT on the neck pain function and cervical range of motion ROM the pressure pain threshold of the trigger points trapezius upper fibers neck muscle strength and the neck angles
2 Compare the effect of CRRT alone to the combined effect of CRRT and manual therapy on the measured outcomes
3 To investigate the long-term effect of CRRT alone or combined with manual therapy on patients with non-specific CNP
Hypotheses Is the application of the CRRT when applied alone or in combination with manual therapy and exercises effective in decreasing pain and improving the function and strength in patients with non-specific chronic neck pain
Ethical Approval
this protocol had an ethical approval from the Institute Review Board of biomedical research ethics committee Umm Al-Qura University Makkah Saudi Arabia A written consent form also will be provided for all participants
Rehabilitation of patients with CNP may include the mechanical electrical and or thermal modalities which are applied with the manual techniques and exercise therapy The capacitive and resistive radiofrequency therapy CRRT is a long-wave diathermy with a long-lasting thermal effect used to decrease pain and muscle spasm in case of lumbago fibromyalgia and knee osteoarthritis
Literature comparing the efficacy of each modality with exercise or with manual therapy Previous literature used CRRT for only its thermal effect The CRRT may combine the effect of thermal electrical and mechanical modalities as well as the effect of exercise and manual therapy with a new technique not used previously This study is the first study using CRRT with a new technique which combines the effect of the CRRT with the manual therapy to treat patients with CNP
Objective of the project
The aim of the present study is to investigate the effect of the CRRT in the treatment of patients with non-specific CNP The CRRT will be applied to the posterior neck and shoulder areas for two sessions per week for six weeks CRRT will be applied alone or combined with manual therapy and stretching exercises
1 To investigate the short-term effect of the CRRT on the neck pain function and cervical range of motion ROM the pressure pain threshold of the trigger points trapezius upper fibers neck muscle strength and the neck angles
2 Compare the effect of CRRT alone to the combined effect of CRRT and manual therapy on the measured outcomes
3 To investigate the long-term effect of CRRT alone or combined with manual therapy on patients with non-specific CNP
Hypotheses Is the application of the CRRT when applied alone or in combination with manual therapy and exercises effective in decreasing pain and improving the function and strength in patients with non-specific chronic neck pain
Ethical Approval
this protocol had an ethical approval from the Institute Review Board of biomedical research ethics committee Umm Al-Qura University Makkah Saudi Arabia A written consent form also will be provided for all participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None