Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373644
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture

Tracking Information
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
 (submitted: February 23, 2015)
  • Change in Disability (ODI) [ Time Frame: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months ]
    10 Questions each worth 0-5 points with maximum score of 50 points
  • Change in Back Pain Intensity (NPRS) [ Time Frame: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months ]
    Numeric Pain Rating
  • Change in Leg pain Intensity (NPRS) [ Time Frame: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months ]
    Numeric Pain Rating
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
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
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
Condition  ICMJE Sacroiliac Joint Dysfunction
Intervention  ICMJE
  • Other: HVLA Thrust Manipulation and DN
    HVLA thrust manipulation targeting primarily the lumbar articulations and sacroiliac joint. Up to 10 sessions over 6 weeks. At least one session of dry needling to the lumbo-pelvic muscles and peri-articular ligaments of the SI joint.
  • Other: Conventional Physical Therapy
    Therapeutic exercise and manual therapy, up to 10 sessions over 6 weeks. Patients may receive interferential current and moist heat.
Study Arms  ICMJE
  • Experimental: HVLA Thrust Manipulation and DN
    Intervention: Other: HVLA Thrust Manipulation and DN
  • Active Comparator: Conventional Physical Therapy
    Intervention: Other: Conventional Physical Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)
116
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2015)
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:

  1. Patient must report sacroiliac dysfunction, defined as:

    • Pain of any duration (acute, subacute, or chronic) in the Fortin region (the pain may also project to the groin, thigh, lower leg and/or foot; however, it may only be local Fortin region pain in some subjects).
    • Pain does NOT centralize with repeated movements or sustained postures
    • A minimum of 3 positive pain provocation tests using either the Laslett et al. (2003, 2005) or van der Wurff et al (2006) multi-test regiments:
    • 3 or more of the following 6 pain provocation tests (Laslett et al, 2003, 2005):
    • Posterior thigh thrust
    • Gaenslen's test (right)
    • Gaenslen's test (left)
    • ASIS distraction
    • ASIS compression
    • Sacral compression
  2. A minimum pain rating of 2/10 using the NPRS (Numeric Pain Rating Scale 0---10)
  3. A minimum ODI score of 10/50 (i.e. 20% minimum on Oswestry Disability Index)

Exclusion Criteria:

  1. Cauda Equina Syndrome
  2. Neurologic presentation consistent with upper or lower motor neuron dysfunction due to spinal involvement (ie myelopathy or nerve compression, hyperreflexia, pathologic reflexes, depressed or absent reflexes in the lower extremities, motor weakness involving major muscle groups of lower extremity, unsteady gait, diminished or absent pin prick sensation in the legs and/or feet)
  3. Spinal fractures
  4. Currently pregnant
  5. Co-existing medial problems / comorbidities (e.g., severe osteoporosis, tumors, inflammatory or infectious conditions, diabetes, angina, severe hypertension, RA, etc.)
  6. Involvement in litigation of worker's compensation claim for low back
  7. Physical therapy or chiropractic treatment for low back pain in the 3 months before initial examination
  8. Any indication that might contraindicate spinal manipulative therapy.
  9. Recent surgery to the lumbar or thoracic spine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: James Dunning, DPT FAAOMPT American Academy of Manipulative Therapy
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