Osteopathic Treatment and Deep Vein Thrombosis (DVT)

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Osteopathic Treatment in Acute Proximal Leg Deep Vein Thrombosis (DVT) to Reduce Pain and Swelling

Conditions
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Deep Vein Thrombosis (DVT)

Intervention / Treatment
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* Other: Osteopathic Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Assessment Only<br>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 | |
| Active Comparator: Assessment and Treatment<br>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<br>* The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month pre and post testing and 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic treatment, Deep Vein Thrombosis, Proximal Leg DVT