Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201607001543279 Date of Approval: 26/03/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of ilium realignment on sacroiliac joint dysfunction and hip joint proprioception
Official scientific title Effect of ilium realignment on sacroiliac joint dysfunction and hip joint proprioception
Brief summary describing the background and objectives of the trial It has been well documented that 80 percent of the population suffers from low back pain at some time during their lives. The sacroiliac joint is reported to be a significant contributor to low back pain in 13% to 30% of patients.The aim of this study was to assess the effect of rigid tape on the intensity of pain, sacroiliac joint mobility, sacroiliac joint pain provocation tests, and the degree of innominate anterior rotation in patients with sacroiliac joint dysfunction. This is in addition to measuring its effect on hip joint active internal and external rotation ranges of motion and active joint reposition sense of hip flexion and abduction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied sacroiliac joint dysfunction
Sub-Disease(s) or condition(s) being studied
Purpose of the trial ilium realignment
Anticipated trial start date 01/04/2015
Actual trial start date 01/04/2015
Anticipated date of last follow up 30/10/2015
Actual Last follow-up date 30/11/2015
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
012/00732 Cairo University, Faculty of Physical Therapy, research ethics' board
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Each patient was asked to select one of two folded papers of the tested groups placed in a container. This was done to assure random assignment of the patients to either of the tested groups Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Each patient was asked to select one of two folded papers of the tested groups placed in a container. This was done to assure random assignment of the patients to either of the tested groups Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Each patient was asked to select one of two folded papers of the tested groups placed in a container. This was done to assure random assignment of the patients to either of the tested groups Open-label(Masking Not Used) Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group zinc oxide tape (Leukotape classic 5cm×10m; BSN medical S.A.S, made in France). changed every three days to provide continuous mechanical correction to the anteriorly rotated innominate for two weeks Two strips of rigid tape were applied following the attachment of hypo-allergic tape. The first piece of rigid tape was applied to restrain anterior ilial translation and was firmly pulled from the ASIS to PSIS in a straight anterior to posterior direction. While, the second piece was applied to restrain anterior ilial rotation and was firmly pulled from the ASIS in an arching manner to the PSIS. 15
Control Group The control group did not receive any intervention 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients were included in the study if they had: Age less than 45 as little radiographic evidence of sacroiliac joint osteoarthritis founded in patients below the age of 45 years. Sacroiliac joint dysfunction as diagnosed by an orthopedist and a rheumatologist. An anterior innominate rotation (as defined by a bilateral difference greater than 2.5 degrees). Pain in and around the sacroiliac region. Pain of at least 5 cm on a 0-10 cm Visual Analog Scale (VAS). Reduced level of pain with manual posterior rotation of the involved ilium. Three or more positive pain provocation tests plus positive active straight leg raising test on the side of excessive innominate anterior rotation. Positive results in three of four tests used in diagnosis of sacroiliac joint dysfunction. These tests included the standing flexion test, palpation of posterior superior iliac spine heights while sitting, the supine and long sitting test, and the prone knee flexion test. Insidious onset of symptoms unrelated to traumatic accident. A decrease in the normal active range of motion of the hip with an asymmetrical range of motion of the hip. Patients were excluded from the study if they had: Any previous or concurrent orthopedic problems of the spine such as: scoliosis, ankylosing spondylitis, spondylolisthesis, lumbar spine traumatic injuries, disc herniation, and lumbar congenital anomalies. Hip fracture, dislocation, pathology or any other condition which may affect hip joint ranges of motion. Previous surgery in either the spine or hip joint. Structural abnormalities or mobility impairments of the knees, ankles, and feet. Neurological, Inflammatory and Respiratory problems. Vestibular system affection (by questioning the participants). Received intra-articular steroid injection in the previous three months. Undergone physical therapy in the 30 days preceding the study. Pregnancy. 30 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/01/2015 faculty of physical therapy ethics board
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayat street, Benn El Sarayat, El Dokki El Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intensity of pain, findings of sacroiliac joint mobility tests, findings of sacroiliac joint pain provocation tests, and the degree of innominate anterior rotation "pretest" before intervention "posttest" after a two week period during which the experimental group received rigid taping for the side of excessive anterior innominate rotation.
Secondary Outcome hip joint active internal and external rotation ranges of motion and absolute angular error of hip flexion and abduction "pretest" before intervention "posttest" after a two week period during which the experimental group received rigid taping for the side of excessive anterior innominate rotation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy, Cairo University 7 Ahmed El Zayat street, Benn El Sarayat, El Dokki El Giza 12612 Egypt
Kasr El Ainy hospital 27 Nafezet Sheem El Shafaey street, Kasr El Ainy Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Egyptian Ministry of Higher Education 101 Kasr El Ainy street, Kasr El Ainy Cairo 11516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Egyptian Ministry of Higher Education 101 Kasr El Ainy street, Kasr El Ainy Cairo Cairo 11516 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Salam Mohammed El Hafez 7 Ahmed El Zayat street, Benn El Sarayat, El Dokki El Giza 12612 Egypt
Susan Sigward 1234 Trousdale Parkway Los Angeles 90089-1234 United States of America
Ghada Abdel Moneim Mohamed 7 Ahmed El Zayat street, Benn El Sarayat, El Dokki El Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Neama Neamat Allah drneamahamed@gmail.com 00201002721535 7 Ahmed El Zayat street, Benn El Sarayat, El Dokki
City Postal code Country Position/Affiliation
El Giza 12612 Egypt Assistant Lecturer at the Department of Biomechanics, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Neama Neamat Allah drneamahamed@gmail.com 00201002721535 7 Ahmed El Zayat street, Benn el sarayat, El Dokki
City Postal code Country Position/Affiliation
El Giza 12612 Egypt Assistant Lecturer at the Department of Biomechanics, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Neama Neamat Allah drneamahamed@gmail.com 00201002721535 7 Ahmed El Zayat street, benn El Sarayat, El Dokki
City Postal code Country Position/Affiliation
El Giza 12612 Egypt Assistant Lecturer at the Department of Biomechanics, Faculty of Physical Therapy, Cairo University
REPORTING
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