The Effect of Osteopathic Treatment in Acute Proximal Leg Deep Vein Thrombosis (DVT) to Reduce Pain and Swelling
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Swelling
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Swelling
Time Frame: 1 month pre and post testing and 2 months
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 Outcomes
- Leg Pain(1 month pre and post testing and 2 months)