NCT01932723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
Last Updated

August 30, 2013

Status Verified

August 1, 2013

Enrollment Period

8 months

First QC Date

June 26, 2013

Last Update Submit

August 27, 2013

Conditions

Keywords

Stabilization exercises, Pain, Disability, Menstruation

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain intensity using Numeric Pain Scale (NPS) were collected at base line and at the end of treatment.

    one year

Secondary Outcomes (1)

  • Disability

    One year

Other Outcomes (1)

  • Kinesiophobia

    One year

Study Arms (1)

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

The functional lumbar stabilization exercises was performed daily, 10 repetitions each, three times a day for three months consecutively.

Also known as: Trunk stabilization exercice, Stability exercise
Lumbar Stabilization Exercises & Control

Eligibility Criteria

Age19 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Social Welfare and Rehabilitation Sciences

Tehran, Tehran Province, 1985713831, Iran

Location

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amir M Arab, PhD

    University of Social Welfare and Rehabilitation Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 26, 2013

First Posted

August 30, 2013

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

January 1, 2012

Last Updated

August 30, 2013

Record last verified: 2013-08

Locations