Radiofrequency Therapy for Chronic Neck Pain.
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.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJune 23, 2022
June 1, 2022
3 months
June 12, 2022
June 18, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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 Outcomes (4)
Neck disability index
Measurement will be performed before treatment.
Neck disability index
Measurement will be performed after 6 weeks of treatment.
Neck disability index
Measurement will be performed after 3 months of treatment as a follow up measurement.
Neck disability index
Measurement will be performed after 6 months of treatment as a follow up measurement.
Other Outcomes (4)
Pressure pain threshold
Measurement will be performed before treatment.
Pressure pain threshold
Measurement will be performed after 6 weeks of treatment.
Pressure pain threshold
Measurement will be performed after 3 months of treatment as a follow up measurement.
- +1 more other outcomes
Study Arms (3)
Exercise and Manual therapy
ACTIVE COMPARATORGroup 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.
Exercise and radiofrequency therapy
ACTIVE COMPARATORGroup 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.
Exercise, Manual and Radiofrequency therapy
ACTIVE COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Umm Al-Qura University, Faculty of Applied Medical Science
Mecca, 21955, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed S Alayat, Ph.D.
Umm Al-Qura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Physical Therapy
Study Record Dates
First Submitted
June 12, 2022
First Posted
June 23, 2022
Study Start
July 1, 2022
Primary Completion
October 1, 2022
Study Completion
December 1, 2022
Last Updated
June 23, 2022
Record last verified: 2022-06