search
Back to results

Osteopathic Treatment and Deep Vein Thrombosis (DVT)

Primary Purpose

Deep Vein Thrombosis (DVT)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Osteopathic Treatment
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis (DVT) focused on measuring Osteopathic treatment, Deep Vein Thrombosis, Proximal Leg DVT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • > 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

Sites / Locations

  • QEll Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Assessment Only

Assessment and Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Leg Pain
Leg Pain will be measured using the visual analogue scale (VAS), at the initial study visit(1 month after diagnosis of the DVT) pre and post assessment or assessment plus treatment. Pain will be evaluated again at the 2 month visit post answering questionnaires and lying supine for 10 minutes.

Full Information

First Posted
July 29, 2014
Last Updated
June 13, 2023
Sponsor
Nova Scotia Health Authority
search

1. Study Identification

Unique Protocol Identification Number
NCT02205294
Brief Title
Osteopathic Treatment and Deep Vein Thrombosis (DVT)
Official Title
The Effect of Osteopathic Treatment in Acute Proximal Leg Deep Vein Thrombosis (DVT) to Reduce Pain and Swelling
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 6, 2014 (Actual)
Primary Completion Date
April 4, 2019 (Actual)
Study Completion Date
April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Osteopathic treatment will provide: A significant reduction of pain and swelling of the affected DVT leg An increase in the quality of life (QOL) for individuals with DVT of the leg Improved signs and symptoms of the post thrombotic syndrome of the affected DVT leg
Detailed Description
Thousands of individuals are affected by deep vein thrombosis (DVT) every year. Medical treatment is aimed at preventing extension and recurrence of the blood clot (DVT) through the use of anticoagulation medication. Compression stockings may be added for reduction of pain and swelling, but this therapy remains controversial amongst physicians. To date, there is limited manual therapies available for individuals affected with DVT. Regular medical treatment, anticoagulation medication, along with osteopathic treatment may offer these individuals improved control of the symptoms associated with DVT. In the long term osteopathic treatment may provide an increase in the quality of life (QOL) and improve the signs and symptoms associated with the post-thrombotic syndrome (PTS), which can be burdensome for both the individual and the health care system. Offering an effective add on treatment could provide individuals and the medical system with an additional means of treatment for the symptoms of DVT and also for the prevention of development of PTS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis (DVT)
Keywords
Osteopathic treatment, Deep Vein Thrombosis, Proximal Leg DVT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assessment Only
Arm Type
No Intervention
Arm Description
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
Arm Title
Assessment and Treatment
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Osteopathic Treatment
Intervention Description
The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.
Primary Outcome Measure Information:
Title
Swelling
Description
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.
Time Frame
1 month pre and post testing and 2 months
Secondary Outcome Measure Information:
Title
Leg Pain
Description
Leg Pain will be measured using the visual analogue scale (VAS), at the initial study visit(1 month after diagnosis of the DVT) pre and post assessment or assessment plus treatment. Pain will be evaluated again at the 2 month visit post answering questionnaires and lying supine for 10 minutes.
Time Frame
1 month pre and post testing and 2 months
Other Pre-specified Outcome Measures:
Title
Quality of LIfe (QOL)
Description
Veines QOL/Sym Questionnaire will be completed by all participants at both study visits to determine if there have been any changes.
Time Frame
1 month and 2 months
Title
Assessment for Post Thrombotic Syndrome (PTS)
Description
The Villalta scale will be used to assess subjects for signs and symptoms of the post-thrombotic syndrome at both study visits.
Time Frame
1 month and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age and older first episode of symptomatic objectively confirmed proximal leg DVT without pulmonary embolism 1 month of appropriate anticoagulation treatment therapeutic level of anticoagulation (ie: Warfarin, INR- 2.0-3.0) Exclusion Criteria: > 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darlene D MacLeod, BscN DOMP
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
QEll Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Pending numbers recruited

Learn more about this trial

Osteopathic Treatment and Deep Vein Thrombosis (DVT)

We'll reach out to this number within 24 hrs