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

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Sacroiliac Disorder
• Intervention / Treatment: Other: manipulation group (MG); Other: electrotheraphy group (EG)

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06071
    • Universidad de Extremadura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Active Comparator: electrotherapy 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 of electrotherapy).	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale (VAS)	Pain assessment from 0 to 10. 0: no pain 10: maximum pain	1 week
Oswestry disability index (ODI)	disability assessment 0% -20% (Minimum Disability) 21% -40% (Moderate disability) 41% -60% (Severe disability) 61% -100% (Disabled):	1 week
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
digital algometer (Wagner, FPIX model)	Pain threshold assessment by pressing the sensitive points of the muscle	1 week

Collaborators and Investigators

• Sponsor: University of Extremadura
• Investigators: Principal Investigator: Jose Antonio JA Rodriguez-Pastor, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain; Study Director: Mª Dolores MD Apolo-Arenas, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain; Study Director: Berta BC Caro-Puértolas, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain; Principal Investigator: Alejandro AC Caña-Pino, PT,MSc, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): January 4, 2019
• Study Completion (Actual): January 4, 2019

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: low back pain; Osteopathic manipulation; sacroiliac joint
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 041218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No