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Clinical Trials/NCT02373644
NCT02373644
Completed
Not Applicable

Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction: a Multi-center Randomized Clinical Trial

Alabama Physical Therapy & Acupuncture1 site in 1 country116 target enrollmentFebruary 21, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sacroiliac Joint Dysfunction
Sponsor
Alabama Physical Therapy & Acupuncture
Enrollment
116
Locations
1
Primary Endpoint
Change in Disability (ODI)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 21, 2015
End Date
January 10, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Alabama Physical Therapy & Acupuncture
Responsible Party
Principal Investigator
Principal Investigator

James Dunning, DPT, MSc, FAAOMPT

DPT MSc FAAOMPT

Alabama Physical Therapy & Acupuncture

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Cauda Equina Syndrome
  • 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)
  • Spinal fractures
  • Currently pregnant
  • Co-existing medial problems / comorbidities (e.g., severe osteoporosis, tumors, inflammatory or infectious conditions, diabetes, angina, severe hypertension, RA, etc.)
  • Involvement in litigation of worker's compensation claim for low back
  • Physical therapy or chiropractic treatment for low back pain in the 3 months before initial examination
  • Any indication that might contraindicate spinal manipulative therapy.
  • Recent surgery to the lumbar or thoracic spine.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in Medication Intake (Frequency of pain medication)(Baseline, 3 months)

Study Sites (1)

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