Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000098730
Ethics application status
Approved
Date submitted
23/01/2013
Date registered
25/01/2013
Date last updated
30/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two different physical therapy treatments for low back pain from the sacroiliac joints
Scientific title
In individuals with chronic sacroiliac joint pain, what is the effect of thoraco-lumbopelvic-femoral exercises on function and pain compared with transverse abdominus exercises, a sacroiliac joint belt, heat, massage and electrical stimulation?
Secondary ID [1] 281797 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sacroiliac Joint Pain 288123 0
Condition category
Condition code
Musculoskeletal 288498 288498 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both groups will receive seven sessions of care, once a week for six weeks administered one-on-one with a physical therapist. The first session is one hour in length and the 2-7th sessions are 45 mins in length. The experimental group (a) is prescribed 6-8 lumbopelvic-femoral exercises only that they do 5 reps held for 4 breaths each and done 2-3 times/day. These are prescribed in a particular order based on whether they have pain on the left side, right side, or bilateral.
Intervention code [1] 286341 0
Rehabilitation
Intervention code [2] 286390 0
Treatment: Other
Comparator / control treatment
The traditional/comparison group (b) will wear a sacroiliac joint belt during waking hours every day, and perform transverse abdominus exercises in four positions: supine hooklying, sitting, sit-tostand-to-sit, and standing, 5-10 reps with a 3 second hold each, 2-3 times/day, and additionally during each session: 10 mins of low back massage, 15 mins of electrical stimulation and heat. Sessions will be administered one-on-one with a physical therapist.
Control group
Active

Outcomes
Primary outcome [1] 288669 0
Oswestry Disability Index
Timepoint [1] 288669 0
six weeks
Secondary outcome [1] 300734 0
Patient Specific Functional Scale
Timepoint [1] 300734 0
6 months (after the 6 weeks)
Secondary outcome [2] 300735 0
Numeric Pain Scale
Timepoint [2] 300735 0
6 months (after the 6 weeks)

Eligibility
Key inclusion criteria
Males and females, 18-75 years old, duration of Sacroiliac joints (SIJs) pain for 3 months or more, pain located over one or both SIJs and/or pain in the buttock (Fortin's area), and three or more positive special tests: Active Straight Leg Raise, Ganslen's, Faber's, Compression, Distraction, Posterior Shear.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pain cephalad to L5, pregnant, pain duration of less than 3 months, treatment received for the SIJ pain within two weeks of beginning the study or during the six weeks of intervention, a long term/permanent deformity/condition such as a knee contracture, scoliosis or Ankylosing Spondylitis and lastly, a Motor Vehicle Accident sustained during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be screened initially via phone for duration and location of pain, and prior treatment history by one of two investigators. If initial inclusion criteria are met, the participant is scheduled for an appointment for one hour. The PT then completes the special tests to see if the inclusion criteria are met. Informed consent will be obtained by one of two physical therapists/investigators prior to treatment allocation. Once eligibility is determined and informed consent received, an office worker will hand a sealed envelope to the treating physical therapist (concealed allocation) to reveal the participant's group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly assigned to the experimental group A: thoraco-lumbopelvic-femoral exercises or the control group B: using a random-sequence generator (random.com). A research assistant has numbered envelopes and placed an index card indicating treatment group allocation to group A if an even number or group B if an odd number. As participants enter the study the envelopes are opened beginning with envelope one and progressing until the study is complete.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic indicators (age, sex, which side was affected, symptom duration) were collected at baseline. Primary outcomes included oswestry disability index, and secondary outcomes included patient specific functional scale and numeric pain scale and were collected at baseline, 6 weeks and 6 months.
To assess baseline differences between intervention and control groups on demographic information and outcomes, we will conduct independent samples' t-test for continuous variables and chi-square tests for categorical variables.
Repeated measures ANOVA with three time points for within and between group differences for outcome measures will be conducted to assess impact of the intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/01/2013
Actual
28/01/2013
Date of last participant enrolment
Anticipated
28/02/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 4819 0
United States of America
State/province [1] 4819 0
North Carolina

Funding & Sponsors
Funding source category [1] 286591 0
University
Name [1] 286591 0
No grant money for this study
Principle investigator hired by
Appalachian State University
Country [1] 286591 0
United States of America
Funding source category [2] 286592 0
Hospital
Name [2] 286592 0
Sanford Physical Therapy Solutions
Country [2] 286592 0
United States of America
Primary sponsor type
University
Name
Appalachian State University
Address
135 Jack Branch Rd.
Boone, NC 28608
Country
United States of America
Secondary sponsor category [1] 285374 0
Hospital
Name [1] 285374 0
Sanford Physical Therapy Solutions
Address [1] 285374 0
1721 S. Cleveland Avenue, Suite 200
Sioux Falls, SD 57103
Country [1] 285374 0
United States of America
Other collaborator category [1] 277252 0
Individual
Name [1] 277252 0
Joan Hanson PT
Sanford Physical Therapy Solutions
Address [1] 277252 0
1721 S. Cleveland Avenue, Suite 200
Sioux Falls, SD 57103
Country [1] 277252 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288665 0
Appalachian State University IRB
Ethics committee address [1] 288665 0
Appalachian State University IRB
Office of Research Protections
ASU Box 32068
Boone, NC 28608
Ethics committee country [1] 288665 0
United States of America
Date submitted for ethics approval [1] 288665 0
Approval date [1] 288665 0
19/12/2012
Ethics approval number [1] 288665 0
IRB Reg 0001458; FWA 00001076
Ethics committee name [2] 288684 0
Sanford USD Medical Center IRB Committee
Ethics committee address [2] 288684 0
Sanford Health Human Research Protection Program
Route #5033
1305 W. 18th Street, Sioux Falls, SD 57117-5039
Ethics committee country [2] 288684 0
United States of America
Date submitted for ethics approval [2] 288684 0
Approval date [2] 288684 0
19/12/2012
Ethics approval number [2] 288684 0

Summary
Brief summary
The purpose of this study is to investigate the effects of two different interventions for low back pain (specifically sacroiliac joint pain) and to compare the effects between intervention groups. The hypothesis is that both groups will result in improvement in pain and function and that the experimental group (unique exercises only) will result in greater improvement than the comparison group (traditional exercises, belt, heat, massage and electrical stimulation).
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37146 0
Dr Kyndall Boyle
Address 37146 0
Appalachian State University
135 Jack Branch Dr.
Owens Field House
Boone, NC 28607
Country 37146 0
United States of America
Phone 37146 0
+1-828-262-2271
Fax 37146 0
+1-828-262-4056
Email 37146 0
boylekl@appstate.edu
Contact person for public queries
Name 37147 0
Dr Kyndall Boyle
Address 37147 0
Appalachian State University
135 Jack Branch Dr.
Owens Field House
Boone, NC 28607
Country 37147 0
United States of America
Phone 37147 0
+1-828-262-2271
Fax 37147 0
+1-828-262-4056
Email 37147 0
boylekl@appstate.edu
Contact person for scientific queries
Name 37148 0
Dr Kyndall boyle
Address 37148 0
Appalachian State University
135 Jack Branch Dr.
Owens Field House
Boone, NC 28607
Country 37148 0
United States of America
Phone 37148 0
+1-828-262-2271
Fax 37148 0
+1-828-262-4056
Email 37148 0
boylekl@appstate.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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