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.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain intensity
时间窗: Measurement will be performed after 6 months of treatment as follow up measurement.
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.
次要结局
- Neck disability index(Measurement will be performed after 6 months of treatment as a follow up measurement.)
研究者
Mohamed Alayat
Associate Professor of Physical Therapy
Umm Al-Qura University