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

• ClinicalTrials.gov Identifier: NCT02373644
• Recruitment Status: Completed
• First Posted: February 27, 2015
• Last Update Posted: February 19, 2020
• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborator: Universidad Rey Juan Carlos
• Information provided by (Responsible Party): James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sacroiliac Joint Dysfunction	Other: HVLA Thrust Manipulation and DN; Other: Conventional Physical Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction: a Multi-center Randomized Clinical Trial
• Actual Study Start Date: February 21, 2015
• Actual Primary Completion Date: January 10, 2020
• Actual Study Completion Date: January 10, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, United States, 36117

Sponsors and Collaborators

Alabama Physical Therapy & Acupuncture

Universidad Rey Juan Carlos

Investigators

• Principal Investigator: James Dunning, DPT FAAOMPT; American Academy of Manipulative Therapy

More Information

• Responsible Party: James Dunning, DPT, MSc, FAAOMPT, DPT MSc FAAOMPT, Alabama Physical Therapy & Acupuncture
• ClinicalTrials.gov Identifier: NCT02373644
• Other Study ID Numbers: AAMT0004
• First Posted: February 27, 2015
• Last Update Posted: February 19, 2020
• Last Verified: October 2019

Additional relevant MeSH terms:

Joint Diseases; Musculoskeletal Diseases