Osteopathic Treatment and Deep Vein Thrombosis (DVT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-06

Study Completion Date

2019-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Single Session Percutaneous Mechanical Thrombectomy for the Treatment of Ilio-femoral Deep Vein Thrombosis: A Preliminary Evaluation

NCT02066597

Deep Vein Thrombosis Venous Thromboembolism

TERMINATED PHASE2

Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis

NCT04411316

Deep Venous Thrombosis Post Thrombotic Syndrome

WITHDRAWN PHASE4

Deep Venous Thrombus Characteristics and Venous Dynamics With Subsequent Thrombus Resolution and Post-thrombotic Syndrome

NCT04597138

Deep Vein Thrombosis

COMPLETED

Venous Thrombectomy/Thrombolysis Outcome Registry

NCT02113475

Deep Venous Thrombosis Post Thrombotic Syndrome

UNKNOWN

Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE)

NCT03465735

Acute DVT of Lower Extremity

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deep Vein Thrombosis (DVT)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Assessment Only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Assessment and Treatment

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

Group Type ACTIVE_COMPARATOR

Osteopathic Treatment

Intervention Type OTHER

The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Osteopathic Treatment

The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes