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Radiofrequency Therapy for Chronic Neck Pain.

Primary Purpose

Neck Pain, Posterior

Status
Not yet recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Capacitive and Resistive Radiofrequency therapy
Exercise therapy
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain, Posterior

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Umm Al-Qura University, Faculty of Applied Medical Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exercise and Manual therapy

Exercise and radiofrequency therapy

Exercise, Manual and Radiofrequency therapy

Arm Description

Group I will be treated with stretching exercises (EX), manual therapy (EX group) and serves as a control group. Stretching of the neck extensor, upper fibers of trapezius, levator scapulae and scalenus muscles. stretching is applied for at least 15 seconds and repeated ten times in each session. Mobilization of the facet joint of the cervical vertebrae is performed after neck exercises.

Group II will be treated with capacitive and resistive radiofrequency therapy plus EX without manual therapy (CRRT+ EX group). In addition to neck stretching exercises, they will receive 20 minutes of CRRT. Both the capacitive and resistive electrodes. CRRT is applied by the INDIBA radiofrequency therapy. INDIBA radiofrequency therapy has a long wavelength diathermy with frequency of 488 KHz range. The integration of two operational modes capacitive electrode (CAP) and (RES), makes it possible to combine sub-thermal (electric) and thermal effects. Indiba radiofrequency has output frequency: 448kHz ± 1 kHz with Maximum output power in RES mode: 100 W and in CAP mode: 350 VA. 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.

Patients in this group will receive the same program of exercises as in group one. in addition, patients will receive the CRRT as in group two and the mobilization of the facet joints of the cervical vertebrae is applied while applied the CRRT by a trained physiotherapist. The same protocol of mobilization is applied for group one and three.

Outcomes

Primary Outcome Measures

Pain intensity
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.
Pain intensity
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.
Pain intensity
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.
Pain intensity
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
June 12, 2022
Last Updated
June 18, 2022
Sponsor
Umm Al-Qura University
Collaborators
Deanship of scientific research at Umm Al-Qura university
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1. Study Identification

Unique Protocol Identification Number
NCT05428254
Brief Title
Radiofrequency Therapy for Chronic Neck Pain.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University
Collaborators
Deanship of scientific research at Umm Al-Qura university

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 P<0.05.
Detailed Description
Chronic neck pain (CNP) is a major health problem affecting individuals with high prevalence 90.4 to 86.8% 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. 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. Compare the effect of CRRT alone to the combined effect of CRRT and manual therapy on the measured outcomes. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Posterior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 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 EX without manual therapy (CRRT+ EX group). Group III will be treated by EX plus manual therapy applied during CRRT for groups (Manual + CRRT+ EX group). For group 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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Individuals with non-specific CNP will be evaluated and referred by independent physicians from orthopedic department at Makkah hospitals. The first author will conduct the processes of participant enrollment and allocation. The allocation of patients is blinded to the assessor and to the therapist. By sealed envelopes, the allocation concealment is achieved. All participants will be eligible to participate after evaluation of independent physician. The physician conducts the processes of participant enrollment, and allocation. The same therapist will treat the patients and the study variables is measured by the same assessors. Randomization is performed using online GraphPad and creating a random number for each patient. Neither the assessor nor the CRRT applicant is oriented about the randomization process. The same therapist will treat the patients, and the study variables will be measured by the same assessor.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Manual therapy
Arm Type
Active Comparator
Arm Description
Group I will be treated with stretching exercises (EX), manual therapy (EX group) and serves as a control group. Stretching of the neck extensor, upper fibers of trapezius, levator scapulae and scalenus muscles. stretching is applied for at least 15 seconds and repeated ten times in each session. Mobilization of the facet joint of the cervical vertebrae is performed after neck exercises.
Arm Title
Exercise and radiofrequency therapy
Arm Type
Active Comparator
Arm Description
Group II will be treated with capacitive and resistive radiofrequency therapy plus EX without manual therapy (CRRT+ EX group). In addition to neck stretching exercises, they will receive 20 minutes of CRRT. Both the capacitive and resistive electrodes. CRRT is applied by the INDIBA radiofrequency therapy. INDIBA radiofrequency therapy has a long wavelength diathermy with frequency of 488 KHz range. The integration of two operational modes capacitive electrode (CAP) and (RES), makes it possible to combine sub-thermal (electric) and thermal effects. Indiba radiofrequency has output frequency: 448kHz ± 1 kHz with Maximum output power in RES mode: 100 W and in CAP mode: 350 VA. 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.
Arm Title
Exercise, Manual and Radiofrequency therapy
Arm Type
Active Comparator
Arm Description
Patients in this group will receive the same program of exercises as in group one. in addition, patients will receive the CRRT as in group two and the mobilization of the facet joints of the cervical vertebrae is applied while applied the CRRT by a trained physiotherapist. The same protocol of mobilization is applied for group one and three.
Intervention Type
Other
Intervention Name(s)
Capacitive and Resistive Radiofrequency therapy
Other Intervention Name(s)
Transfer Electrical Capacitive And Resistive (TECAR therapy)
Intervention Description
TECAR or CRRT is electromagnetic waves produced by high frequency electrical current that are able to penetrate very deep and produce a long-lasting heat which stimulates the superficial and dep tissues and produce a potent long-lasting pain-relieving effect. Mild intensity of heat produced by the long wave diathermy may be used to promote proliferation (Hernández-Bule et al., 2014) and improve the vascularization of skin and muscles. The integration of two operational modes, Capacitive (CAP) and Resistive (RES), makes it possible to combine sub-thermal (electric) and thermal effects. Indiba radiofrequency has output frequency: 448kHz ± 1 kHz with Maximum output power in RES mode: 100 W and in CAP mode: 350 VA. The capacitive used an isolated metal coated electrode acts as a dielectric surface which concentrate the electrical charges near the capacitive electrode While the resistive electrode causing the diffusion of electrical charges which accumulate near bone and soft tissues.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
Stretching of the neck extensor, upper fibers of trapezius, levator scapulae and scalenus muscles. stretching is applied for at least 15 seconds and repeated ten times in each session.
Primary Outcome Measure Information:
Title
Pain intensity
Description
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.
Time Frame
Measurement will be performed before treatment.
Title
Pain intensity
Description
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.
Time Frame
Measurement will be performed after 6 weeks of treatment.
Title
Pain intensity
Description
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.
Time Frame
Measurement will be performed after 3 months of treatment as follow up measurement.
Title
Pain intensity
Description
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.
Time Frame
Measurement will be performed after 6 months of treatment as follow up measurement.
Secondary Outcome Measure Information:
Title
Neck disability index
Description
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
Time Frame
Measurement will be performed before treatment.
Title
Neck disability index
Description
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
Time Frame
Measurement will be performed after 6 weeks of treatment.
Title
Neck disability index
Description
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
Time Frame
Measurement will be performed after 3 months of treatment as a follow up measurement.
Title
Neck disability index
Description
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
Time Frame
Measurement will be performed after 6 months of treatment as a follow up measurement.
Other Pre-specified Outcome Measures:
Title
Pressure pain threshold
Description
Trigger points in the posterior neck and upper fibers of trapezius muscle will be allocated and evaluated using the pressure algometer.
Time Frame
Measurement will be performed before treatment.
Title
Pressure pain threshold
Description
Trigger points in the posterior neck and upper fibers of trapezius muscle will be allocated and evaluated using the pressure algometer.
Time Frame
Measurement will be performed after 6 weeks of treatment.
Title
Pressure pain threshold
Description
Trigger points in the posterior neck and upper fibers of trapezius muscle will be allocated and evaluated using the pressure algometer.
Time Frame
Measurement will be performed after 3 months of treatment as a follow up measurement.
Title
Pressure pain threshold
Description
Trigger points in the posterior neck and upper fibers of trapezius muscle will be allocated and evaluated using the pressure algometer.
Time Frame
Measurement will be performed after 6 months of treatment as follow up measurement.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with chronic neck pain. Age is above 18 years. patients had chronic pain ≥ 3 months, The radiological examination showed that the patients is free from any discogenic cause of pain. Patients are willing to stop medications. 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: They have any known significant medical conditions such as hypertension, asthma, cardiac disease, or systemic disease that adversely affect them during testing. Previous neck surgery/injection for the last six months. Previous vertebral fracture or malignancy. Patients have a discogenic pain or any other radicular manifestation to the upper limb. Unable to commit study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed S Alayat, Ph.D
Phone
+966566003665
Email
mohsalahpt@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Alayat, Ph.D
Email
msayiat@uqu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S Alayat, Ph.D.
Organizational Affiliation
Umm Al-Qura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umm Al-Qura University, Faculty of Applied Medical Science
City
Mecca
ZIP/Postal Code
21955
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Radiofrequency Therapy for Chronic Neck Pain.

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