NIPH Clinical Trials Search

JRCT ID: jRCT1022210037

Registered date:15/09/2021

Examination on effect of pain relief regarding Upper limb aerobic exercise in concert with Tanscutaneous electrical nerve stimulation (TENS) for acute pain

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedacute pain of entire body,Low back pain
Date of first enrollment15/09/2021
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)In this task, in addition to the usual therapeutic intervention for lumbar compression fractures, the subjects were single intervention for upper limb aerobic exercise (hereinafter, single intervention) and combination intervention for upper limb aerobic exercise and TENS (hereinafter, combined). It is divided into groups that receive either intervention) or no upper limb aerobic exercise and TENS (normal therapeutic intervention only control). Each group is referred to as a single intervention group, a combination intervention group, and a control group, respectively. The subjects will be randomly assigned to each group by a preliminary lottery. When the subject receives single intervention, combined intervention, or control, the subject first holds a gatch up sitting position with eyes closed for 5minutes on the bed in his or her room as a habituation time. Immediately after the end of the acclimation time, the susceptibility to pain (pain threshold) is measured using a tenderness meter. For the next 30minutes, the subject transitions to a sitting position on the bed and receives either single intervention, combined intervention, or control. As for control, upper limb aerobic exercise and TENS are not performed, so the subject only keeps a sitting position for 30minutes. In this task, 4week intervention period is set to examine the degree of change and recovery of acute pain over time, and various interventions are performed 4times or week. On top of that, the timing of performing various evaluations such as measurement of the pain threshold is at the start of the intervention (baseline) and at 5points in the 1st, 2nd, 3rd, and 4th weeks after the start of the intervention. Regarding the method of performing upper limb aerobic exercise, the subjects of the single intervention group and the combined intervention group used the upper limb ergometer (alexia, Alexandave Industries co., Ltd.) as the upper limb aerobic exercise for 30minutes immediately after the end of the habituation time. Perform the exercise you were doing while sitting on the bed in your room. Since no previous study was found that mentioned exercise intensity for the upper limb ergometer, it is performed with a light load. Specifically, the number of rotations of the upper limb ergometer shall be an arbitrary number of rotations that the subject can carry out, and the degree to which the subject feels easy in the subjective exercise intensity. In particular, subjects in the combined intervention group will undergo 30minutes of TENS at the same time as the above mentioned exercise using the upper limb ergometer. In this task, we will use bilateral simultaneous TENS, which is often reported to have a high analgesic effect even in previous studies. A low frequency therapy device (ESPRGE, Ito ultra short wave) is used to perform TENS. Regarding the stimulation conditions of TENS, the current intensity is said to have a high analgesic effect, the degree to which muscle contraction without pain or discomfort occurs (hereinafter, exercise level), and the frequency and pulse width are at the exercise level. 3Hz and 100 msec, respectively, according to the general conditions of the TENS performed. The current strength of each TENS should be confirmed and determined in advance before the start of the acclimatization time. The electrode attachment site for TENS will be on the dermatome of the 3rd lumbar spinal cord (hereinafter, L3) and the 4th lumbar spinal cord (hereinafter, L4) on both thighs according to the previous study.


Primary OutcomeA tenderness meter is used to measure the pain threshold. Since the subjects in this study were patients with acute lumbar disease, the measurement site of the pain threshold due to restrictions such as wearing a corset by conservative therapy was on the skin of the eagle foot (on the dermatome of L3 and L4) according to the previous study. On the skin of the muscle belly of the central fiber of the triangular muscle. In addition, in this task, from the viewpoint of examining changes in the systemic pain threshold by simultaneous bilateral TENS and upper limb ergometer, the pain threshold is measured at four symmetrical locations. The tenderness meter is pressed vertically against the measurement site at a speed of 5 Newtons per second as much as possible, and the value (unit Newton) of the tenderness meter at the time when the subject's sensation changes from pressure to pain is used as the pain threshold. This measurement method has already been established in previous studies. In addition, in order to guarantee the reproducibility of the measurement site in several pain threshold measurements, the skin surface of each measurement site is regularly marked with an oil based black pen.
Secondary OutcomeEvaluation of Functional Independence Measure (FIM), which is an evaluation index for activities of daily living (ADL), and evaluation of quality of life (QOL) The four indexes are the Ronald-Morris Disability Questionnaire (RDQ), which is an index, and the 10m walk test (10MWT), which is an evaluation index related to walking ability. The details of the measurement method of each index will be described below.

Key inclusion & exclusion criteria

Age minimum>= 60age old
Age maximum<= 80age old
Include criteriaWe essencialy adress the specific patients who have diagnozed Lumber Compression Fracture by the doctor at the hospital and agree with us
Exclude criteriaExcluding is the patients who arguably have a dementia as a resuil of Mini-Mental State Examination(MMSE) ,20 points in total.

Related Information


Public contact
Name Ryota Kudo
Address Aomori,ishie,3-chome-1 Aomori Japan 038-0003
Telephone +81-80-4514-8491
Affiliation Aomori Shintoshi Hospital
Scientific contact
Name Youichi Katayama
Address Aomori,ishie,3-chome-1 Aomori Japan 038-0003
Telephone +81-177578750
Affiliation Aomori Shintoshi Hospital