Osteopathic Treatment and Deep Vein Thrombosis (DVT)

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

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

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis (DVT)
• Intervention / Treatment: Other: Osteopathic Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • QEll Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Darlene D MacLeod, BscN DOMP, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2014
• Primary Completion (Actual): April 4, 2019
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimated): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Deep Vein Thrombosis; Osteopathic treatment; Proximal Leg DVT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: REB ROMEO # 1017573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Pending numbers recruited