Clinical trial NCT05428254: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain, Posterior
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
Collaborators: name: Deanship of scientific research at Umm Al-Qura university
First posted: 2022-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: Measurement will be performed before treatment.
measure: Pain intensity
timeFrame: Measurement will be performed after 6 weeks of treatment.
measure: Pain intensity
timeFrame: Measurement will be performed after 3 months of treatment as follow up measurement.
measure: Pain intensity
timeFrame: Measurement will be performed after 6 months of treatment as follow up measurement.
Secondary outcomes:
measure: Neck disability index
timeFrame: Measurement will be performed before treatment.
measure: Neck disability index
timeFrame: Measurement will be performed after 6 weeks of treatment.
measure: Neck disability index
timeFrame: Measurement will be performed after 3 months of treatment as a follow up measurement.
measure: Neck disability index
timeFrame: Measurement will be performed after 6 months of treatment as a follow up measurement.
Other outcomes:
measure: Pressure pain threshold
timeFrame: Measurement will be performed before treatment.
measure: Pressure pain threshold
timeFrame: Measurement will be performed after 6 weeks of treatment.
measure: Pressure pain threshold
timeFrame: Measurement will be performed after 3 months of treatment as a follow up measurement.
measure: Pressure pain threshold
timeFrame: Measurement will be performed after 6 months of treatment as follow up measurement.
Locations:
city: Mecca
country: Saudi Arabia
facility: Umm Al-Qura University, Faculty of Applied Medical Science
Study officials:
affiliation: Umm Al-Qura University
name: Mohamed S Alayat, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: