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

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

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.

Study Overview

• Status: Completed
• Conditions: Sacroiliac Joint Dysfunction
• Intervention / Treatment: Other: HVLA Thrust Manipulation and DN; Other: Conventional Physical Therapy

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
      • Alabama Physical Therapy & Acupuncture

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborators: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: James Dunning, DPT FAAOMPT, American Academy of Manipulative Therapy

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2015
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: AAMT0004