Deep Vein Thrombosis (DVT)NCT02205294
Osteopathic Treatment and Deep Vein Thrombosis (DVT)
A study testing Osteopathic Treatment in people with Deep Vein Thrombosis (DVT), run by Nova Scotia Health Authority at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Vein Thrombosis (DVT)
- What is being tested?
- Osteopathic Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 6 Nov 2014to 4 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- > 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Osteopathic Treatment in Acute Proximal Leg Deep Vein Thrombosis (DVT) to Reduce Pain and Swelling
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
Read the 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.
- Conditions
- Deep Vein Thrombosis (DVT)
- Being tested
- Osteopathic Treatment
- Keywords
- Osteopathic treatment, Deep Vein Thrombosis, Proximal Leg DVT
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic TreatmentOther
The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.
| Study group | Role | What they receive |
|---|---|---|
| Assessment Only | No intervention | 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 |
| Assessment and Treatment | Active comparator | 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 Receives: Other: Osteopathic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month pre and post testing and 2 months
Secondary outcomes (1)
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.
Measured: 1 month pre and post testing and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study start6 Nov 2014
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis (DVT)Studies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darlene D MacLeod, BscN DOMP, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205294
- Sponsor's protocol ID
- REB ROMEO # 1017573
- Status last verified
- Jun 2023
- First submitted
- 29 Jul 2014
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Pending numbers recruited
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Treatment in Acute Proximal Leg Deep Vein Thrombosis (DVT) to Reduce Pain and Swelling
- ClinicalTrials.gov ID
- NCT02205294
- Acronym / sponsor ID
- REB ROMEO # 1017573
- Conditions
- Deep Vein Thrombosis (DVT)
- Keywords
- Osteopathic treatment, Deep Vein Thrombosis, Proximal Leg DVT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 6 Nov 2014 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment Only | No intervention | –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 |
| Assessment and Treatment | Active comparator | Other: Osteopathic TreatmentSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- > 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic TreatmentThe osteopathic treatment will be a gentle hands treatment using myofascial release techniques. | Other | Assessment and Treatment |
Primary outcome
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.
1 secondary outcome
Leg Pain
Time frame: 1 month pre and post testing and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided. Pending numbers recruited
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darlene D MacLeod, BscN DOMP principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Treatment in people with Deep Vein Thrombosis (DVT), run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swelling (time frame: 1 month pre and post testing and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.