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

NCT02373644 | Completed

• 1 other identifier: AAMT0004
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Joint Dysfunction

Outcome Measures

Primary Outcomes (3)

• Change in Disability (ODI)

  10 Questions each worth 0-5 points with maximum score of 50 points

  Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months

• Change in Back Pain Intensity (NPRS)

  Numeric Pain Rating

  Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months

• Change in Leg pain Intensity (NPRS)

  Numeric Pain Rating

  Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months

Secondary Outcomes (1)

• Change in Medication Intake (Frequency of pain medication)

  Baseline, 3 months

Study Arms (2)

HVLA Thrust Manipulation and DN

EXPERIMENTAL

Other: HVLA Thrust Manipulation and DN

Conventional Physical Therapy

ACTIVE COMPARATOR

Other: Conventional Physical Therapy

Interventions

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.

HVLA Thrust Manipulation and DN

Conventional Physical Therapy OTHER

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

Conventional Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

Location

Study Officials

• James Dunning, DPT FAAOMPT

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DPT MSc FAAOMPT

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 27, 2015
• Study Start: February 21, 2015
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: February 19, 2020

Record last verified: 2019-10

Locations

US (1)