Impact of Manipulation of Sacroiliac Joints on the Static Balance of the Body

NCT04387032 | Completed

• 1 other identifier: HVLA manipulations
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The study can be identified as an experimental study with a quasi-randomized control. It consisted of HVLA manipulation on blocked sacroiliac joints (SIJ) and it was checked whether it affected the appropriate parameters determining the pressure center (COP). The value of the parameters were examined twice, before (PRE) and after (POST) manipulation. The results were compared with the control group (people without hypomobility SIJ) in which sham manipulation was performed, and COP parameters (PRE and POST) were measured twice. In addition, PRE and POST results were compared within the group, i.e. separately in the experimental group (E) and separately in the control group (C) to check the effect of HVLA manipulation and placebo manipulation. The first hypothesis assumes that persons belonging to the experimental group are characterized by significantly higher values of COP parameters before manipulation than values in the control group. The second hypothesis assumes that COP parameters will normalize as a result of sacroiliac joint mobilization performed in the experimental group.

Conditions

Asymptomatic Condition; Sacroiliac Disorder

Keywords

manual therapy; HVLA manipulation; sacroiliac joint; center of pressure (COP); hypomobility

Outcome Measures

Primary Outcomes (10)

• COP X PRE

  deflection of the COP in the X axis before manipulation

  PRE (immediately before the intervention)

• COP X POST

  deflection of the COP in the X axis after manipulation

  POST (immediately after the intervention)

• COP Y PRE

  deflection of the COP in the Y axis before manipulation

  PRE (immediately before the intervention)

• COP Y POST

  deflection of the COP in the Y axis after manipulation

  POST (immediately after the intervention)

• COP Length PRE

  path travelled by COP before manipulation;

  PRE (immediately before the intervention)

• COP Length POST

  path travelled by COP after manipulation;

  POSt (immediately after the intervention)

• COP Area PRE

  COP area before manipulation

  PRE (immediately before the intervention)

• COP Area POST

  COP area after manipulation

  POST (immediately after the intervention)

• COP Av.Q-speed PRE

  the average speed of COP before manipulation

  PRE (immediately before the intervention)

• COP Av.Q-speed POST

  the average speed of COP after manipulation

  POST (immediately after the intervention)

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group (students with hypomobile SIJs)

Other: HVLA Manipulations

Control group

SHAM COMPARATOR

control group (students without hypomobile SIJs)

Other: Sham Manipulation

Interventions

HVLA Manipulations OTHER

The procedure of experimental manipulation: the patient lay on the healthy side with the straight lower limb, and the torso turned towards the dysfunctional side, whose lower limb was bent in the hip and knee joint, and the hands rest on the lower ribs on the same side. The therapist allowed the initial loosening of the tissues and chose the movement barrier with his stabilizing hand. Then, with the treatment hand, he introduced the HVLA thrust through the iliac bone towards the bottom, while giving the iliac bone a posterior or anterior rotation - meaning, the opposite to the occurring dysfunction. If during the manipulation, no cavitation sound was heard, the HVLA thrust was repeated once.

Also known as: manual therapy

Experimental group

Sham Manipulation OTHER

The sham procedure was the same, but no external force was introduced in the form of a therapeutic impulse.

Control group

Eligibility Criteria

• Age: 19 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Student at the Poznan University of Physical Education;
• age 19-24;
• asymptomaticity in the form of no pain symptoms in the LS segment of the spine;
• written consent to participate in the study;
• presenting no disqualification criteria;
• no health contraindications to perform manipulation;
• no hypomobility of the SI joints, negative mobility test results PRE (to the control group);
• occurrence of hypomobility of the SI joint on one or both sides PRE (to the experimental group);
• noting the sound of cavitation during the procedure (in the experimental group);
• confirmation of a treatment effectiveness by noting negative results of SI joints mobility tests POST (in the experimental group).

You may not qualify if:

• Persons who were characterized by LBP, neurological symptoms, rheumatic problems, orthopedic, or ongoing treatment in the lumbar spine and pelvis area were excluded. Pregnancy and the anatomical difference in the length of the lower limbs exceeding 5mm were also an excluding criterion.

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznan University of Physical Education, Department of Biology and Anatomy

Poznan, Wielkopolska, 61-871, Poland

Location

Related Publications (9)

• Vleeming A, Schuenke MD, Masi AT, Carreiro JE, Danneels L, Willard FH. The sacroiliac joint: an overview of its anatomy, function and potential clinical implications. J Anat. 2012 Dec;221(6):537-67. doi: 10.1111/j.1469-7580.2012.01564.x. Epub 2012 Sep 19.

  PMID: 22994881 BACKGROUND

• Coulter ID, Crawford C, Hurwitz EL, Vernon H, Khorsan R, Suttorp Booth M, Herman PM. Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis. Spine J. 2018 May;18(5):866-879. doi: 10.1016/j.spinee.2018.01.013. Epub 2018 Jan 31.

  PMID: 29371112 BACKGROUND

• Lord SR, Clark RD, Webster IW. Physiological factors associated with falls in an elderly population. J Am Geriatr Soc. 1991 Dec;39(12):1194-200. doi: 10.1111/j.1532-5415.1991.tb03574.x.

  PMID: 1960365 BACKGROUND

• Bemis T, Daniel M. Validation of the Long Sitting Test on Subjects with lliosacral Dysfunction*. J Orthop Sports Phys Ther. 1987;8(7):336-45. doi: 10.2519/jospt.1987.8.7.336.

  PMID: 18797042 BACKGROUND

• Arab AM, Abdollahi I, Joghataei MT, Golafshani Z, Kazemnejad A. Inter- and intra-examiner reliability of single and composites of selected motion palpation and pain provocation tests for sacroiliac joint. Man Ther. 2009 Apr;14(2):213-21. doi: 10.1016/j.math.2008.02.004. Epub 2008 Mar 25.

  PMID: 18373938 BACKGROUND

• Grassi Dde O, de Souza MZ, Ferrareto SB, Montebelo MI, Guirro EC. Immediate and lasting improvements in weight distribution seen in baropodometry following a high-velocity, low-amplitude thrust manipulation of the sacroiliac joint. Man Ther. 2011 Oct;16(5):495-500. doi: 10.1016/j.math.2011.04.003. Epub 2011 May 14.

  PMID: 21570892 RESULT

• Koes BW, Assendelft WJ, van der Heijden GJ, Bouter LM. Spinal manipulation for low back pain. An updated systematic review of randomized clinical trials. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2860-71; discussion 2872-3. doi: 10.1097/00007632-199612150-00013.

  PMID: 9112710 RESULT

• von Heymann WJ, Schloemer P, Timm J, Muehlbauer B. Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo. Spine (Phila Pa 1976). 2013 Apr 1;38(7):540-8. doi: 10.1097/BRS.0b013e318275d09c.

  PMID: 23026869 RESULT

• Farazdaghi MR, Motealleh A, Abtahi F, Panjan A, Sarabon N, Ghaffarinejad F. Effect of sacroiliac manipulation on postural sway in quiet standing: a randomized controlled trial. Braz J Phys Ther. 2018 Mar-Apr;22(2):120-126. doi: 10.1016/j.bjpt.2017.09.002. Epub 2017 Sep 8.

  PMID: 28993042 RESULT

MeSH Terms

Conditions

Asymptomatic Diseases

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Małgorzata Waszak, PhD

  Poznan University of Physical Education

  STUDY DIRECTOR

• Michał Posłuszny, MSc

  Poznan University of Physical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: blinded patient blinded researcher and person evaluating results
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Model Details: Experimental group - HVLA manipulations on blocked sacroiliac joints (SIJs) Control group (people without hypomobile SIJs), in which we performed sham manipulation

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 13, 2020
• Study Start: June 15, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available from June 2020.
• Access Criteria: Available to all researchers

Locations

PL (1)