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

NCT ID: NCT03794830

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2019-01-04

Brief Summary

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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

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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

Conditions

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Low Back Pain Sacroiliac Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

manipulation group (MG)

Intervention Type OTHER

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

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).

Group Type ACTIVE_COMPARATOR

electrotheraphy group (EG)

Intervention Type OTHER

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)

Interventions

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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

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Extremadura

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Caña Pino

Principal Investigator. Medical Surgical-Therapy Department, Universidad de Extremadura Facultad de Medicina, Badajoz, Spain

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose Antonio JA Rodriguez-Pastor, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

Mª Dolores MD Apolo-Arenas, PhD

Role: STUDY_DIRECTOR

Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

Berta BC Caro-Puértolas, PhD

Role: STUDY_DIRECTOR

Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

Alejandro AC Caña-Pino, PT,MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

Locations

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Universidad de Extremadura

Badajoz, , Spain

Site Status

Countries

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Spain

Other Identifiers

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041218

Identifier Type: -

Identifier Source: org_study_id

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