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

Primary Purpose

Sacroiliac Joint Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HVLA Thrust Manipulation and DN

Conventional Physical Therapy

About this trial

This is an interventional treatment trial for Sacroiliac Joint Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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)

Exclusion Criteria:

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.

Sites / Locations

Alabama Physical Therapy & Acupuncture

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HVLA Thrust Manipulation and DN

Conventional Physical Therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in Disability (ODI)

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

Change in Back Pain Intensity (NPRS)

Numeric Pain Rating

Change in Leg pain Intensity (NPRS)

Numeric Pain Rating

Secondary Outcome Measures

Change in Medication Intake (Frequency of pain medication)

Frequency of pain medication (narcotics and over-the counter drugs) required for low back / pelvic pain

Full Information

NCT ID

NCT02373644

First Posted

February 10, 2015

Last Updated

February 18, 2020

Sponsor

Alabama Physical Therapy & Acupuncture

Collaborators

Universidad Rey Juan Carlos

1. Study Identification

Unique Protocol Identification Number

NCT02373644

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

February 21, 2015 (Actual)

Primary Completion Date

January 10, 2020 (Actual)

Study Completion Date

January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alabama Physical Therapy & Acupuncture

Collaborators

Universidad Rey Juan Carlos

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sacroiliac Joint Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HVLA Thrust Manipulation and DN

Arm Type

Experimental

Arm Title

Conventional Physical Therapy

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

HVLA Thrust Manipulation and DN

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Conventional Physical Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Disability (ODI)

Description

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

Time Frame

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

Title

Change in Back Pain Intensity (NPRS)

Description

Numeric Pain Rating

Time Frame

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

Title

Change in Leg pain Intensity (NPRS)

Description

Numeric Pain Rating

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Medication Intake (Frequency of pain medication)

Description

Frequency of pain medication (narcotics and over-the counter drugs) required for low back / pelvic pain

Time Frame

Baseline, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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) Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Dunning, DPT FAAOMPT

Organizational Affiliation

American Academy of Manipulative Therapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alabama Physical Therapy & Acupuncture

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36117

Country

United States

12. IPD Sharing Statement

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

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