The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain With or Without Radiation to Lower Limbs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794830
• Other study ID #: 041218
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: January 4, 2019

Study information

• Verified date: February 2019
• Source: University of Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary focus of this study is to know the influence of sacroiliac joint manipulation on low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint

Description:

One of the main problems faced by physiotherapists in primary care is low back pain with or without radiation to lower limbs. Nowadays, there are a lot of types of low back pain interventions, yet despite the vast amount of research findings, the evidence remains contradictory and inconclusive: Pharmacological treatments like NSAIDs have shown result in acute low back pain but not in chronic pain; conservative interventions (ultrasound, interferential currents, mechanical traction and massage) have been studied and found ineffective.

A total of 151 low back pain patients with or without radiation to lower limbs between 18-70 years old derived from the Physiotherapy Unit of Gévora Health Center (Badajoz, Spain) voluntarily entered the study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 4, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• dysfunction or sacroiliac joint hypomobility (SI)

• having stopped taking anti-inflammatory medicines or analgesics three days before the study began

Exclusion Criteria:

• destructive injuries of the spine and pelvis

• fractures

• lumbar surgery

• sacroiliac instability

• spondylolisthesis

• pregnancy in progress

• cauda equina syndrome

• abdominal aneurysm

• infection

• inflammatory arthritis

• tumors

• osteoporosis

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Sacroiliac Disorder

Intervention

Other:
• manipulation group (MG)
Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks
• electrotheraphy group (EG)
Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions)

Locations

Country	Name	City	State
Spain	Universidad de Extremadura	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
University of Extremadura

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale (VAS)	Pain assessment from 0 to 10. 0: no pain 10: maximum pain	1 week
Primary	Oswestry disability index (ODI)	disability assessment 0% -20% (Minimum Disability) 21% -40% (Moderate disability) 41% -60% (Severe disability) 61% -100% (Disabled):	1 week
Primary	Roland Morris questionnaire	disability assessment The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)	1 week
Primary	digital algometer (Wagner, FPIX model)	Pain threshold assessment by pressing the sensitive points of the muscle	1 week