NCT06366971

Brief Summary

The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050. Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP. Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear. Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 5, 2024

Last Update Submit

April 14, 2024

Conditions

Keywords

flexibilitymobilitypainproprioceptive neuromuscular facilitationsacroiliac joint dysfunction

Outcome Measures

Primary Outcomes (6)

  • The Level of Low Back Pain

    The intensity of low back pain will be rated subjectively on a 100-mm visual analog scale (VAS), where 0-mm indicated "no pain" and 100-mm indicated "worst possible pain"

    6 weeks

  • Mobility

    The Modified Schober's test will be used to assess mobility of lower back.

    6 weeks

  • Flexibility

    The sit-and-reach test will be used to assess flexibility of lower back.

    6 weeks

  • Lumbar Range of Motion

    A long-arm universal goniometer will be used to measure the lumbar range of motion. Flexion, extension, right and left lateral flexion, and right and left rotation will be assess.

    6 weeks

  • Posture

    The postural alignment will be assessed by using the New York Posture Rating Chart. Total score ranges between 13 and 65 points which higher scores indicate correct/normal postural alignment.

    6 weeks

  • Trunk Muscle Endurance

    Trunk flexor and extensor muscle endurance will be assessed with the flexor endurance test and Biering-Sørensen test, respectively.

    6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will receive exercise training consisting of pelvic PNF techniques in addition to patient education which consisting of basic lumbar stabilization exercises 3 days a week for 6-weeks.

Other: The Patient EducationOther: The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training

Control Group

ACTIVE COMPARATOR

The control group will receive patient education consisting of basic lumbar stabilization exercises 3 days a week for 6-weeks.

Other: The Patient Education

Interventions

The patient education will be given through a brochure and the content of the education included an exercise training consisting of simple exercises for lumbar stabilization (supine bridge, cat-camel, and lumbar stretching) and the participants will be asked to perform these exercises in 3 sets of 10 repetitions 3 days a week for 6-weeks.

Control GroupExperimental Group

The content of the pelvic proprioceptive neuromuscular facilitation techniques training will include the application of the anterior depression pattern with the rhythmic initiation technique and the application of the posterior elevation pattern with the contract-relax stretch technique. All PNF techniques will be performed in 3 sets of 10 to 12 repetitions. The pelvic proprioceptive neuromuscular facilitation techniques training will be delivered face to face 3 days a week for 6 weeks by an experienced and trained physiotherapist.

Experimental Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having a diagnosis of SIJD
  • Being between the ages of 18 and 40
  • Volunteering to participate in the study

You may not qualify if:

  • Having a history of any neurological, psychiatric and/or orthopedic disease
  • Being pregnant or having a suspicion of pregnancy
  • Having one or more of disc herniations, spondylosis, spondylolisthesis and/or similar lumbar pathologies that may cause low back pain
  • Having a history of previous spine/hip/lower extremity surgery
  • Having a history of active malignancy and/or infection
  • Having a history of any injection and/or surgical procedure for the sacroiliac joint within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Kagıthane, 34408, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 16, 2024

Study Start

December 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations