Effect of Functional Lumbar Stabilization Exercises in Wo... | NCT01932723

Studies
Effect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain

NCT01932723

Sponsor

University of Social Welfare and Rehabilitation Science

Status

Completed

Last Update Posted

Aug 30, 2013Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

Lumbar stabilization exercises

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Aug 27, 2013

First Posted Date

Aug 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2013

Last Update Posted Date

Aug 30, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amir Massoud Arab, Dr., University of Social Welfare and Rehabilitation SciencePrincipal Investigator

Lead Sponsor

University of Social Welfare and Rehabilitation ScienceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Behavioral: Lumbar stabilization exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lumbar stabilization exercises	Behavioral	The functional lumbar stabilization exercises was performed daily, 10 repetitions each, three times a day for three months consecutively.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	Pain intensity using Numeric Pain Scale (NPS) were collected at base line and at the end of treatment.	one year

Secondary Outcomes

Measure	Description	Time Frame
Disability	Oswestry disability index (ODI) and Roland-Morris questionnaire (RMQ) were collected at base line and at the end of treatment.	One year

Other Outcomes

Measure	Description	Time Frame
Kinesiophobia	Tampa scale of kinesiophobia (TSK) were collected at base line and at the end of treatment.	One year

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amir M Arab, PhD	University of Social Welfare and Rehabilitation Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Social Welfare and Rehabilitation Sciences		Tehran	Tehran Province	1985713831	Iran

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain
D010146	Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided