NCT01172574

Brief Summary

The objective of this study was to explore the effectiveness of Motor Control Exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

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

November 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
Last Updated

July 30, 2010

Status Verified

January 1, 2008

First QC Date

July 28, 2010

Last Update Submit

July 29, 2010

Conditions

OsteoporosisPostmenopausal

Keywords

OsteoporosisPainKyphosisPostureExercise therapy

Outcome Measures

Primary Outcomes (3)

  • Pain

    Pain was assessed using the visual analogue scale (VAS) of 11 numerical points (0='no pain', 10='worst imaginable pain'). Participants were asked to verbalize the presence of pain in their trunk and lower limbs during the previous 2 weeks.

    Baseline

  • Pain

    As described

    3 months

  • Pain

    As described

    6 months

Secondary Outcomes (6)

  • Photographic measurements

    Baseline

  • Spinal curvatures

    Baseline

  • Photographic measurements

    3 months

  • Spinal curvatures

    3 months

  • Photographic measurements

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Motor control exercise

EXPERIMENTAL

Subjects of the exercise group underwent a 3-month (13-week) treatment program directed on 3-weekly 1-hr one-to-one sessions by the researcher who had experience in the specific exercise treatment of the spinal region. During the next 3 months, the subjects were urged to perform the exercises alone at home at least once a day, and compliance was monitored by the activity quota chart given to them at the beginning of each study-month.

Other: Motor control exercise

Control group

NO INTERVENTION

The control group underwent treatment throughout a 6-month period, directed by each patient's medical practitioner. This consisted of the patients carrying out regular weekly general exercises (walking and swimming). Three of them regularly attended other treatment providers involving group general exercise programs. Two patients received the application of local pain-relieving methods such as heat, massage, laser and ultrasound and one did nothing except for receiving osteoporotic medication.

Interventions

Motor control exerciseOTHER

Participants of the exercise group were trained to consciously co-activate the transversus abdominis, pelvic floor and thoracic erector spinae muscle, relax the lumbar multifidus and use the diaphragmatic breathing pattern. They were encouraged to activate the specific muscles of the trunk regularly during daily activities, particularly in situations where they anticipated or experienced pain such as walking, twisting, lifting low-lying objects and working with the hands in sitting or standing positions

Motor control exercise

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal osteoporosis
  • Osteoporotic vertebral fractures
  • Pain
  • Under medical osteoporotic treatment

You may not qualify if:

  • osteoporosis other than primary postmenopausal
  • vertebral collapse with neurological deficits
  • more than 5 fractured vertebrae
  • major respiratory conditions
  • receiving pain reducing agents, teriparatide or calcitonin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Thias Pronoias 'I Pammakaristos'

Athens, Attica, 11144, Greece

Location

MeSH Terms

Conditions

OsteoporosisPainKyphosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal CurvaturesSpinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 30, 2010

Study Start

November 1, 2006

Study Completion

January 1, 2008

Last Updated

July 30, 2010

Record last verified: 2008-01

Locations

GR(1)