The objective of this study is to assess the pain-relief efficacy of radiofrequency (RF)-thermal stimulation on acupuncture points (APs) in the treatment of patients suffering from low back pain (LBP) as a preliminary study. The study was designed as a randomized, practitioner-blinded, active control trial. A total of 56 LBP patients whose minimum pain intensity on visual analogue scale (VAS, 0-100mm) was more than 30mm were randomly allocated to either control or treatment group. The treatment group received RF thermal stimulation plus cupping therapy on four bilateral and three unilateral APs for three times a week. The active-controlled group (n=28) received false thermal stimulation but cupping therapy on the identical APs with the treatment group. All patients after randomization were required to report the case report form at baseline, all of three times of treatment periods and the follow-up period within a week after all treatments. 

Treatment

Intervention group
1) Treatment group: radiofrequency (RF)-thermal stimulation plus cupping therapy
2) Active controlled group: cupping therapy

Deion of Interventions
1) RF-thermal stimulation: RF of 2 MHz was applied at intervals of 2000 ms through channel 1, and the actual stimulation duration of each application was configured to 400 ms. The output power was initially set at 20 W (10% of the maximum output power). The stimulation applied on approximately six selected acupoints (APs) among five bilateral (BL23, BL24, BL25, BL30, and BL40) and three unilateral (GV3, GV4, and GV5) APs. 
2) Cupping therapy: The cupping pressure with 15 kPa induced by the cup-shaped probes was applied on the identical APs with RF-thermal stimulation.

Time/Duration of Intervention: Three times of intervention over one week

Arm Label

Target Number of Participant

Arm Type

Arm Description

Combination of radiofrequency (RF) thermal stimulation and cupping pressure on approximately six selected acupoints (APs) among five bilateral (BL23, BL24, BL25, BL30, and BL40) and three unilateral (GV3, GV4, and GV5) APs for ten minutes, three times over a week . RF of 2 MHz was applied at intervals of 2000 ms through channel 1, and the actual stimulation duration of each application was configured to 400 ms. The output power was initially set at 20 W (10% of the maximum output power), and the cupping pressure was 15 kPa. 

Arm Label

Target Number of Participant

Arm Type

Arm Description

An identical negative pressure used in the treatment group was applied. All acupoints, duration of pressure, frequency and duration of treatment was identical with the treatment group. The devices used in both the treatment group and the active control group were manufactured with identical appearances, but radiofrequency irradiation output of the device used for the active control group was not operational. The practitioners were only able to identify each device according to the masked group labels.Acoustic sounds mimicking the application of RF thermal stimulation were also delivered by the devices to preserve the group blinding of the practitioners.

Gender

Age

Description

1. Patients with a minimum pain intensity score greater than 30 mm on a visual analogue scale (VAS, 0 to 100 mm)
2. Diagnosed as the low back pain with medical evidences (e.g. previous radiographic records and independent physical examination)
3. Voluntary participation who clearly understood purpose and characteristics of the clinical trials signed informed consent form  

1. Patients who required the aid of medical devices or attached implantable equipment that could be affected by electromagnetic fields, such as pacemakers or hearing aids
2. Unendurable pain, bone fractures, severe disc herniation, or spinal tumours.
3. Taking drugs such as corticosteroids, anticonvulsants, or anti-inflammatory agents.
4. Pregnancy
5. Patients who experienced any adverse effects due to the physical stimulation therapy
6. Cognitive or mental dysfunction
7. Participated in other clinical trials within the last month

Change in visual analogue scale (VAS, 100 mm) from the baseline to follow-up period

Baseline, every three times of treatment over the course of one week (visit 1 to visit 3), and within one week after the end of all scheduled treatments (visit 4: follow-up).

Change of pressure pain threshold (PPT) 

Every three times of treatment over the course of one week, and within one week after the end of all scheduled treatments (visit 4: follow-up).

Change of patient's global impression of change (PGIC) 

Every three times of treatment over the course of one week (visit 1 to visit 3), and within one week after the end of all scheduled treatments (visit 4: follow-up).

European Quality of Life-5 Dimensions (EQ-5D)

The first time of the treatment (visit 1) and within one week after the end of all scheduled treatments (visit 4: follow-up).