NCT03794830

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

1 month

First QC Date

January 3, 2019

Last Update Submit

February 7, 2019

Conditions

Low Back PainSacroiliac Disorder

Keywords

sacroiliac jointlow back painOsteopathic manipulation

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

manipulation group (MG)

EXPERIMENTAL

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)

electrotherapy group (EG)

ACTIVE COMPARATOR

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)

Interventions

manipulation group (MG)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

manipulation group (MG)
electrotheraphy group (EG)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)

electrotherapy group (EG)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dysfunction or sacroiliac joint hypomobility (SI)
  • having stopped taking anti-inflammatory medicines or analgesics three days before the study began

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Extremadura

Badajoz, 06071, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose Antonio JA Rodriguez-Pastor, PhD

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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

  • Alejandro AC Caña-Pino, PT,MSc

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator. Medical Surgical-Therapy Department, Universidad de Extremadura Facultad de Medicina, Badajoz, Spain

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 7, 2019

Study Start

December 4, 2018

Primary Completion

January 4, 2019

Study Completion

January 4, 2019

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

ES(1)