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The Effect of Osteopathic Manual Therapy on Vascular Supply

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wendy Jardine, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT01020591
First received: November 24, 2009
Last updated: March 24, 2017
Last verified: March 2017
Results First Received: February 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Knee Osteoarthritis
Interventions: Other: Osteopathic evaluation
Other: Osteopathic evaluation with treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty subjects between the age of 48 and 80 years with radiographic confirmed knee OA were recruited. All data collection took place at the School of Health Sciences Room 658 Bethune building on South park St in Halifax Nova Scotia between January and March of 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Osteopathic Evaluation osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
Osteopathic Evaluation With Treatment osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues

Participant Flow:   Overall Study
    Osteopathic Evaluation   Osteopathic Evaluation With Treatment
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Osteopathic Evaluation osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
Osteopathic Evaluation With Treatment osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
Total Total of all reporting groups

Baseline Measures
   Osteopathic Evaluation   Osteopathic Evaluation With Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7  46.7%      7  46.7%      14  46.7% 
>=65 years      8  53.3%      8  53.3%      16  53.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.73  (9.63)   63.20  (7.97)   63.47  (8.80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  80.0%      10  66.7%      22  73.3% 
Male      3  20.0%      5  33.3%      8  26.7% 
Region of Enrollment 
[Units: Participants]
     
Canada   15   15   30 


  Outcome Measures

1.  Primary:   Resistive Index (RI)   [ Time Frame: Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day ]

2.  Secondary:   The Knee Flexion Active Range of Motion, Balance and Pain (VAS)   [ Time Frame: Jan 2010 to March 2010 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Wendy Jardine
Organization: CDHA
phone: 902 429 6218
e-mail: wendymjardine@gmail.com



Responsible Party: Wendy Jardine, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01020591     History of Changes
Other Study ID Numbers: CDHA-RS/2010-227
Study First Received: November 24, 2009
Results First Received: February 12, 2012
Last Updated: March 24, 2017