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Completed

NCT Number: NCT02373644

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Sacral compression
  • A minimum pain rating of 2/10 using the NPRS (Numeric Pain Rating Scale 0---10)
  • A minimum ODI score of 10/50 (i.e. 20% minimum on Oswestry Disability Index)

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.

Treatment and study plan

HVLA Thrust Manipulation and DN

Other

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.

Conventional physical therapy

Other

Therapeutic exercise and manual therapy, up to 10 sessions over 6 weeks. Patients may receive interferential current and moist heat.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2015
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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