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

Sacroiliac Joint Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373644
• Other study ID #: AAMT0004
• Status: Completed
• Phase: N/A
• Start date: February 21, 2015
• Est. completion date: January 10, 2020

Study information

• Verified date: October 2019
• Source: Alabama Physical Therapy & Acupuncture
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Sacroiliac Joint Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	Alabama Physical Therapy & Acupuncture	Montgomery	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Back Pain Intensity (NPRS)	Numeric Pain Rating	Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months
Primary	Change in Leg pain Intensity (NPRS)	Numeric Pain Rating	Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months
Secondary	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