- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932723
Effect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain (LBP)
August 27, 2013 updated by: Amir Massoud Arab, University of Social Welfare and Rehabilitation Science
Effect of Functional Lumbar Stabilization Exercises on Pain, Disability and Kinesiophobia in Women With Menstrual Low Back Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tehran, Iran, Islamic Republic of, 1985713831
- University of Social Welfare and Rehabilitation Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 39 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lumbar Stabilization Exercises & Control
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.
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The functional lumbar stabilization exercises was performed daily, 10 repetitions each, three times a day for three months consecutively.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: one year
|
Pain intensity using Numeric Pain Scale (NPS) were collected at base line and at the end of treatment.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability
Time Frame: One year
|
Oswestry disability index (ODI) and Roland-Morris questionnaire (RMQ) were collected at base line and at the end of treatment.
|
One year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinesiophobia
Time Frame: One year
|
Tampa scale of kinesiophobia (TSK) were collected at base line and at the end of treatment.
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One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amir M Arab, PhD, University of Social Welfare and Rehabilitation Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
June 26, 2013
First Submitted That Met QC Criteria
August 27, 2013
First Posted (Estimate)
August 30, 2013
Study Record Updates
Last Update Posted (Estimate)
August 30, 2013
Last Update Submitted That Met QC Criteria
August 27, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 891025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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