NCT02205294

Brief Summary

Osteopathic treatment will provide:

  1. 1.A significant reduction of pain and swelling of the affected DVT leg
  2. 2.An increase in the quality of life (QOL) for individuals with DVT of the leg
  3. 3.Improved signs and symptoms of the post thrombotic syndrome of the affected DVT leg

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

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 6, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

4.4 years

First QC Date

July 29, 2014

Last Update Submit

June 13, 2023

Conditions

Deep Vein Thrombosis (DVT)

Keywords

Osteopathic treatmentDeep Vein ThrombosisProximal Leg DVT

Outcome Measures

Primary Outcomes (1)

  • Swelling

    Swelling will be measured using a tension-controlled tape measure at the initial study visit, one month after diagnosis of the subject's DVT and then again at 2 months after diagnosis.

    1 month pre and post testing and 2 months

Secondary Outcomes (1)

  • Leg Pain

    1 month pre and post testing and 2 months

Other Outcomes (2)

  • Quality of LIfe (QOL)

    1 month and 2 months

  • Assessment for Post Thrombotic Syndrome (PTS)

    1 month and 2 months

Study Arms (2)

Assessment Only

NO INTERVENTION

Subjects will have an osteopathic assessment to determine areas of tension in specific areas of the body. These areas include: the thoracic diaphragm, the heart and pericardium, the iliac fascia, the femoral sheath, the sartorius muscle, the pelvic diaphragm and the interosseous membrane (IM) of the lower extremity

Assessment and Treatment

ACTIVE COMPARATOR

Subjects will have an osteopathic assessment to determine areas of tension in specific areas of the body. These areas of tension will receive osteopathic treatment, using myofascial release techniques. These areas include: the thoracic diaphragm, the heart and pericardium, the iliac fascia, the femoral sheath, the sartorius muscle, the pelvic diaphragm and the interosseous membrane (IM) of the lower extremity

Other: Osteopathic Treatment

Interventions

Osteopathic TreatmentOTHER

The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.

Assessment and Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • first episode of symptomatic objectively confirmed proximal leg DVT without pulmonary embolism
  • month of appropriate anticoagulation treatment
  • therapeutic level of anticoagulation (ie: Warfarin, INR- 2.0-3.0)

You may not qualify if:

  • \> 1 month + 7 days of anticoagulation
  • history of previously confirmed proximal or distal leg DVT
  • medically unstable individuals requiring hospitalization
  • history of peripheral vascular disease (PVD)
  • injury of affected leg (trauma within the last 6 months or leg currently casted)
  • history of previous stroke
  • uncontrolled hypertension
  • renal failure requiring hemodialysis or peritoneal dialysis
  • diagnosis of cancer in the last five years or currently receiving treatment for cancer
  • open heart or vascular surgery in the last year
  • any neurological condition (ie: MS, ALS, Parkinsons, etc)
  • currently pregnant
  • geographic inaccessibility
  • unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEll Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Darlene D MacLeod, BscN DOMP

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 31, 2014

Study Start

November 6, 2014

Primary Completion

April 4, 2019

Study Completion

April 4, 2019

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

CA(1)