Low Back PainLBPNCT01932723
Effect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain
A study testing Lumbar stabilization exercises in people with Low Back Pain, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar stabilization exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Jan 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
University of Social Welfare and Rehabilitation Sciences
Tehran, Tehran Province, 1985713831
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Lumbar stabilization exercises
- Keywords
- Stabilization exercises, Pain, Disability, Menstruation
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar stabilization exercisesBehavioural
Also called Trunk stabilization exercice, Stability exercise
The functional lumbar stabilization exercises was performed daily, 10 repetitions each, three times a day for three months consecutively.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Stabilization Exercises & Control | Experimental | 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. Receives: Behavioral: Lumbar stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain intensity using Numeric Pain Scale (NPS) were collected at base line and at the end of treatment.
Measured: one year
Secondary outcomes (1)
Disability
Oswestry disability index (ODI) and Roland-Morris questionnaire (RMQ) were collected at base line and at the end of treatment.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Massoud Arab, University of Social Welfare and Rehabilitation Science
- Investigators
- Amir M Arab, PhD, Principal investigator, University of Social Welfare and Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932723
- Sponsor's protocol ID
- 891025
- Acronym
- LBP
- Status last verified
- Aug 2013
- First submitted
- 26 Jun 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Lumbar Stabilization Exercises on Pain, Disability and Kinesiophobia in Women With Menstrual Low Back Pain
- ClinicalTrials.gov ID
- NCT01932723
- Acronym / sponsor ID
- LBP / 891025
- Conditions
- Low Back Pain
- Keywords
- Stabilization exercises, Pain, Disability, Menstruation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar Stabilization Exercises & Control | Experimental | Behavioral: Lumbar stabilization exercisesLumbar stabilization exercises daily, 10 repetitions each (three times a day) for three months consecutively. All exercises were performed to a count of 7 seconds. |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar stabilization exercisesAlso: Trunk stabilization exercice, Stability exerciseThe functional lumbar stabilization exercises was performed daily, 10 repetitions each, three times a day for three months consecutively. | Behavioural | Lumbar Stabilization Exercises & Control |
Primary outcome
Pain
Time frame: one year
Pain intensity using Numeric Pain Scale (NPS) were collected at base line and at the end of treatment.
1 secondary outcome
Disability
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir M Arab, PhD principal investigator
University of Social Welfare and Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar stabilization exercises in people with Low Back Pain, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.