Osteopathic Treatment and Deep Vein Thrombosis (DVT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02205294|
Recruitment Status : Active, not recruiting
First Posted : July 31, 2014
Last Update Posted : July 30, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis (DVT)||Other: Osteopathic Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Osteopathic Treatment in Acute Proximal Leg Deep Vein Thrombosis (DVT) to Reduce Pain and Swelling|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||November 2019|
No Intervention: 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
Active Comparator: 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
Other: Osteopathic Treatment
The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.
- 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.
- Leg Pain [ Time Frame: 1 month pre and post testing and 2 months ]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.
- Quality of LIfe (QOL) [ Time Frame: 1 month and 2 months ]Veines QOL/Sym Questionnaire will be completed by all participants at both study visits to determine if there have been any changes.
- Assessment for Post Thrombotic Syndrome (PTS) [ Time Frame: 1 month and 2 months ]The Villalta scale will be used to assess subjects for signs and symptoms of the post-thrombotic syndrome at both study visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205294
|Canada, Nova Scotia|
|QEll Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Principal Investigator:||Darlene D MacLeod, BscN DOMP||Nova Scotia Health Authority|