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Osteopathic Treatment and Deep Vein Thrombosis (DVT)

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ClinicalTrials.gov Identifier: NCT02205294
Recruitment Status : Active, not recruiting
First Posted : July 31, 2014
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Darlene MacLeod, Nova Scotia Health Authority

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

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis (DVT) Other: Osteopathic Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Canada, Nova Scotia
QEll Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: Darlene D MacLeod, BscN DOMP Nova Scotia Health Authority

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Responsible Party: Darlene MacLeod, RN BScN DOMP, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02205294     History of Changes
Other Study ID Numbers: REB ROMEO # 1017573
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Pending numbers recruited
Keywords provided by Darlene MacLeod, Nova Scotia Health Authority:
Osteopathic treatment
Deep Vein Thrombosis
Proximal Leg DVT
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases