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

Primary Purpose

Low Back Pain, Sacroiliac Disorder

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
manipulation group (MG)
electrotheraphy group (EG)
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring sacroiliac joint, low back pain, Osteopathic manipulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad de Extremadura

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

manipulation group (MG)

electrotherapy group (EG)

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 3, 2019
Last Updated
February 7, 2019
Sponsor
University of Extremadura
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1. Study Identification

Unique Protocol Identification Number
NCT03794830
Brief Title
The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain
Official Title
The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain With or Without Radiation to Lower Limbs
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
January 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Sacroiliac Disorder
Keywords
sacroiliac joint, low back pain, Osteopathic manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
manipulation group (MG)
Arm Type
Experimental
Arm Description
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
Arm Title
electrotherapy group (EG)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
manipulation group (MG)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
electrotheraphy group (EG)
Intervention Description
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)
Primary Outcome Measure Information:
Title
visual analogue scale (VAS)
Description
Pain assessment from 0 to 10. 0: no pain 10: maximum pain
Time Frame
1 week
Title
Oswestry disability index (ODI)
Description
disability assessment 0% -20% (Minimum Disability) 21% -40% (Moderate disability) 41% -60% (Severe disability) 61% -100% (Disabled):
Time Frame
1 week
Title
Roland Morris questionnaire
Description
disability assessment The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
Time Frame
1 week
Title
digital algometer (Wagner, FPIX model)
Description
Pain threshold assessment by pressing the sensitive points of the muscle
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Antonio JA Rodriguez-Pastor, PhD
Organizational Affiliation
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Dolores MD Apolo-Arenas, PhD
Organizational Affiliation
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Berta BC Caro-Puértolas, PhD
Organizational Affiliation
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alejandro AC Caña-Pino, PT,MSc
Organizational Affiliation
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Extremadura
City
Badajoz
ZIP/Postal Code
06071
Country
Spain

12. IPD Sharing Statement

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

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