Osteopathic Treatment and Deep Vein Thrombosis (DVT)

Nova Scotia Health Authority (NSHA)

Status: Completed

Conditions: Deep Vein Thrombosis (DVT)

Treatments: Other: Osteopathic Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02205294

REB ROMEO # 1017573

Details and patient eligibility

About

Osteopathic treatment will provide:

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Assessment Only

No Intervention group

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

Assessment and Treatment

Active Comparator group

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

Treatment:

Other: Osteopathic Treatment