Osteopathic Treatment and Deep Vein Thrombosis (DVT)

Deep Vein Thrombosis (DVT) Clinical Trial

Official title:

The Effect of Osteopathic Treatment in Acute Proximal Leg Deep Vein Thrombosis (DVT) to Reduce Pain and Swelling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205294
• Other study ID #: REB ROMEO # 1017573
• Status: Completed
• Phase: N/A
• Start date: November 6, 2014
• Est. completion date: April 4, 2019

Study information

• Verified date: June 2023
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 4, 2019
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis (DVT)
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Osteopathic Treatment
The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.

Locations

Country	Name	City	State
Canada	QEll Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of LIfe (QOL)	Veines QOL/Sym Questionnaire will be completed by all participants at both study visits to determine if there have been any changes.	1 month and 2 months
Other	Assessment for Post Thrombotic Syndrome (PTS)	The Villalta scale will be used to assess subjects for signs and symptoms of the post-thrombotic syndrome at both study visits.	1 month and 2 months
Primary	Swelling	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.	1 month pre and post testing and 2 months
Secondary	Leg Pain	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.	1 month pre and post testing and 2 months