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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

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.

Condition or disease Intervention/treatment Phase
Sacroiliac Joint Dysfunction Other: HVLA Thrust Manipulation and DN Other: Conventional Physical Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction: a Multi-center Randomized Clinical Trial
Actual Study Start Date : February 21, 2015
Actual Primary Completion Date : January 10, 2020
Actual Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HVLA Thrust Manipulation and DN 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.

Active Comparator: Conventional Physical Therapy Other: Conventional Physical Therapy
Therapeutic exercise and manual therapy, up to 10 sessions over 6 weeks. Patients may receive interferential current and moist heat.




Primary Outcome Measures :
  1. 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

  2. Change in Back Pain Intensity (NPRS) [ Time Frame: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months ]
    Numeric Pain Rating

  3. Change in Leg pain Intensity (NPRS) [ Time Frame: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months ]
    Numeric Pain Rating


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373644


Locations
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United States, Alabama
Alabama Physical Therapy & Acupuncture
Montgomery, Alabama, United States, 36117
Sponsors and Collaborators
Alabama Physical Therapy & Acupuncture
Universidad Rey Juan Carlos
Investigators
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Principal Investigator: James Dunning, DPT FAAOMPT American Academy of Manipulative Therapy
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Responsible Party: James Dunning, DPT, MSc, FAAOMPT, DPT MSc FAAOMPT, Alabama Physical Therapy & Acupuncture
ClinicalTrials.gov Identifier: NCT02373644    
Other Study ID Numbers: AAMT0004
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: October 2019
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases