NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032190085

Registered date:27/08/2019

HAL for low back pain

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedChronic non-specific low back pain
Date of first enrollment25/10/2019
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Exercise therapy with HAL lumbar type.

Outcome(s)

Primary OutcomeSafety Aggravation of low back pain will be defined as 50% or more increment of low back pain and 25mm increment of pain intensity in visual analogue scale.
Secondary OutcomeSuggestive efficacy (30% pain reduction in VAS score, 3points or more improvement in Roland Morris questionner, 5points or more reduction of Oswestry disability index.)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria1) Patients with chronic (3Mo~) , non-specific low back pain with moderate/severe pain (VAS 50mm or more) 2) Patients who agree to participate in the current trial and from whom informed consent was obtained orally and in writing. 3) Patients with age of 20 to 75 years. 4) Outpatients 5) Patients who are able to wear HAL lubar type.
Exclude criteria1) Patients who cannot wear HAL lumbar type (possibly due to extreme obesity, skin disorders, etc.) 2) Patients with sever co-morbidity 3) Patients who have conciousness disorder 4) Patients with past history of lumbar surgery 5) Patients with osteoporosis

Related Information

Contact

Public contact
Name Masao Koda
Address 2-1-1 Amakubo, Tsukuba, Ibaraki Ibaraki Japan 305-8575
Telephone +81-29-853-3219
E-mail masaokod@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital
Scientific contact
Name Masao Koda
Address 2-1-1 TAmakubo,, Tsukuba, Ibaraki Ibaraki Japan 305-8575
Telephone +81-29-853-3219
E-mail masaokod@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital