Clinical trial NCT02205294: 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
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis (DVT)
Keywords: Osteopathic treatment
Deep Vein Thrombosis
Proximal Leg DVT
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

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

Primary outcomes:
measure: Swelling
timeFrame: 1 month pre and post testing and 2 months
Secondary outcomes:
measure: Leg Pain
timeFrame: 1 month pre and post testing and 2 months
Other outcomes:
measure: Quality of LIfe (QOL)
timeFrame: 1 month and 2 months
measure: Assessment for Post Thrombotic Syndrome (PTS)
timeFrame: 1 month and 2 months
Locations:
city: Halifax
country: Canada
facility: QEll Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Darlene D MacLeod, BscN DOMP
role: PRINCIPAL_INVESTIGATOR
References: