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

Not Applicable

Completed

• Conditions: Sacroiliac Joint Dysfunction
• Interventions: Other: HVLA Thrust Manipulation and DN; Other: Conventional Physical Therapy

• Registration Number: NCT02373644
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-02-10
• Study Start: 2015-02-21
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-02-27
• Status Verified: 2019-10
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HVLA Thrust Manipulation and DN	HVLA Thrust Manipulation and DN	-
Conventional Physical Therapy	Conventional Physical Therapy	-

Primary Outcome Measures

Name	Time	Method
Change in Disability (ODI)	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)	Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months	Numeric Pain Rating
Change in Leg pain Intensity (NPRS)	Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months	Numeric Pain Rating

Secondary Outcome Measures

Name	Time	Method
Change in Medication Intake (Frequency of pain medication)	Baseline, 3 months	Frequency of pain medication (narcotics and over-the counter drugs) required for low back / pelvic pain

Trial Locations

Locations (1)

Alabama Physical Therapy & Acupuncture; 🇺🇸 Montgomery, Alabama, United States