Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction
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ClinicalTrials.gov Identifier: NCT02373644 |
Recruitment Status :
Completed
First Posted : February 27, 2015
Last Update Posted : February 19, 2020
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Sponsor:
Alabama Physical Therapy & Acupuncture
Collaborator:
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
Tracking Information | ||||
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First Submitted Date ICMJE | February 10, 2015 | |||
First Posted Date ICMJE | February 27, 2015 | |||
Last Update Posted Date | February 19, 2020 | |||
Actual Study Start Date ICMJE | February 21, 2015 | |||
Actual Primary Completion Date | January 10, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Change in Medication Intake (Frequency of pain medication) [ Time Frame: Baseline, 3 months ] Frequency of pain medication (narcotics and over-the counter drugs) required for low back / pelvic pain
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction | |||
Official Title ICMJE | Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction: a Multi-center Randomized Clinical Trial | |||
Brief Summary | The purpose of the research project is to compare the effectiveness of non-thrust mobilization and exercise versus thrust manipulation and dry needling in patients with sacroiliac dysfunction. Physical therapists commonly use both approaches to treat sacroiliac joint dysfunction, and this study is attempting to determine if one approach is more effective than the other. | |||
Detailed Description | Patients with sacroiliac pain will be randomized to receive 1-2 treatments per week for 6 weeks (up to 10 sessions total) of either: 1. High-velocity, low-amplitude (HVLA) thrust manipulation and dry needling group, or 2. conventional physical therapy (Stabilization, force closure, motor control exercises and manual therapy) group. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Sacroiliac Joint Dysfunction | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
116 | |||
Original Estimated Enrollment ICMJE |
95 | |||
Actual Study Completion Date ICMJE | January 10, 2020 | |||
Actual Primary Completion Date | January 10, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02373644 | |||
Other Study ID Numbers ICMJE | AAMT0004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture | |||
Study Sponsor ICMJE | Alabama Physical Therapy & Acupuncture | |||
Collaborators ICMJE | Universidad Rey Juan Carlos | |||
Investigators ICMJE |
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PRS Account | Alabama Physical Therapy & Acupuncture | |||
Verification Date | October 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |