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Completed

NCT Number: NCT02205294

Osteopathic Treatment and Deep Vein Thrombosis (DVT)

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

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Key information

Conditions

Deep Vein Thrombosis (DVT) Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QEll Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Treatment

Other

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

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2014
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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