Back to resultsEffect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain (LBP)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Lumbar stabilization exercises
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Stabilization exercises, Pain, Disability, Menstruation
Eligibility Criteria
Inclusion Criteria:
- Having low back pain LBP during menstrual phase (days 1-6) of the menstrual cycle.
- Suffering from low back pain during all menstrual cycles in the year before the study.
- No back pain or low back paiun at times other than the menstrual phase.
- Pain intensity during menstrual LBP greater than 5 in Numeric Pain Scale
Exclusion Criteria:
- History of spinal surgery, spinal or pelvic fracture and hospitalization for severe trauma or car accident, urinary tract infection, vaginal infection and known neurological disorders.
- Pain intensity lesser than 5 in Numeric Pain Scale
Sites / Locations
- University of Social Welfare and Rehabilitation Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lumbar Stabilization Exercises & Control
Arm Description
Lumbar stabilization exercises daily, 10 repetitions each (three times a day) for three months consecutively. All exercises were performed to a count of 7 seconds.
Outcomes
Primary Outcome Measures
Pain
Pain intensity using Numeric Pain Scale (NPS) were collected at base line and at the end of treatment.
Secondary Outcome Measures
Disability
Oswestry disability index (ODI) and Roland-Morris questionnaire (RMQ) were collected at base line and at the end of treatment.
Full Information
NCT ID
NCT01932723
First Posted
June 26, 2013
Last Updated
August 27, 2013
Sponsor
University of Social Welfare and Rehabilitation Science
1. Study Identification
Unique Protocol Identification Number
NCT01932723
Brief Title
Effect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain
Acronym
LBP
Official Title
Effect of Functional Lumbar Stabilization Exercises on Pain, Disability and Kinesiophobia in Women With Menstrual Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Social Welfare and Rehabilitation Science
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Menstrual low back pain (LBP) is one of the common complaints among women. Menstrual LBP may be attributed to the spinal instability resulting from ligament laxity due to hormonal change. The purpose of this study was to investigate the effect of functional lumbar stabilization exercises on pain, disability and kinesiophobia in women with menstrual LBP.
Detailed Description
Pain intensity using Numeric Pain Scale (NPS), Oswestry disability index (ODI), Roland-Morris questionnaire (RMQ) and Tampa scale of kinesiophobia (TSK) were collected at base line and at the end of treatment (after three months) in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Stabilization exercises, Pain, Disability, Menstruation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumbar Stabilization Exercises & Control
Arm Type
Experimental
Arm Description
Lumbar stabilization exercises daily, 10 repetitions each (three times a day) for three months consecutively. All exercises were performed to a count of 7 seconds.
Intervention Type
Behavioral
Intervention Name(s)
Lumbar stabilization exercises
Other Intervention Name(s)
Trunk stabilization exercice, Stability exercise
Intervention Description
The functional lumbar stabilization exercises was performed daily, 10 repetitions each, three times a day for three months consecutively.
Primary Outcome Measure Information:
Title
Pain
Description
Pain intensity using Numeric Pain Scale (NPS) were collected at base line and at the end of treatment.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Disability
Description
Oswestry disability index (ODI) and Roland-Morris questionnaire (RMQ) were collected at base line and at the end of treatment.
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Kinesiophobia
Description
Tampa scale of kinesiophobia (TSK) were collected at base line and at the end of treatment.
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Having low back pain LBP during menstrual phase (days 1-6) of the menstrual cycle.
Suffering from low back pain during all menstrual cycles in the year before the study.
No back pain or low back paiun at times other than the menstrual phase.
Pain intensity during menstrual LBP greater than 5 in Numeric Pain Scale
Exclusion Criteria:
History of spinal surgery, spinal or pelvic fracture and hospitalization for severe trauma or car accident, urinary tract infection, vaginal infection and known neurological disorders.
Pain intensity lesser than 5 in Numeric Pain Scale
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir M Arab, PhD
Organizational Affiliation
University of Social Welfare and Rehabilitation Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Social Welfare and Rehabilitation Sciences
City
Tehran
ZIP/Postal Code
1985713831
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain
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