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NCT Number: NCT03794830

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

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

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sacroiliac Disorder Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Extremadura

Badajoz, 06071, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

Primary outcomes

  1. visual analogue scale (VAS)

    Time frame: 1 week

    Pain assessment from 0 to 10. 0: no pain 10: maximum pain

  2. Oswestry disability index (ODI)

    Time frame: 1 week

    disability assessment 0% -20% (Minimum Disability) 21% -40% (Moderate disability) 41% -60% (Severe disability) 61% -100% (Disabled):

  3. Roland Morris questionnaire

    Time frame: 1 week

    disability assessment The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)

  4. digital algometer (Wagner, FPIX model)

    Time frame: 1 week

    Pain threshold assessment by pressing the sensitive points of the muscle

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 7, 2019
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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