HAL for low back pain

JRCT ID: jRCTs032190085

Registered date:27/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic non-specific low back pain
• Date of first enrollment: 25/10/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Exercise therapy with HAL lumbar type.

Outcome(s)

Primary Outcome

Safety
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 Outcome

Suggestive 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
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Koda Masao