Sacroiliac Joint DysfunctionNCT02373644
Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction
A study testing HVLA Thrust Manipulation and DN and Conventional Physical Therapy in people with Sacroiliac Joint Dysfunction, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- HVLA Thrust Manipulation and DN and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2015to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alabama Physical Therapy & Acupuncture
Montgomery, Alabama, 36117
About this study
Official title: 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.
Read the 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.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- HVLA Thrust Manipulation and DN, Conventional Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVLA Thrust Manipulation and DNOther
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 TherapyOther
Therapeutic exercise and manual therapy, up to 10 sessions over 6 weeks. Patients may receive interferential current and moist heat.
| Study group | Role | What they receive |
|---|---|---|
| HVLA Thrust Manipulation and DN | Experimental | Not described Receives: Other: HVLA Thrust Manipulation and DN |
| Conventional Physical Therapy | Active comparator | Not described Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disability (ODI)
10 Questions each worth 0-5 points with maximum score of 50 points
Measured: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months
Change in Back Pain Intensity (NPRS)
Numeric Pain Rating
Measured: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months
Change in Leg pain Intensity (NPRS)
Numeric Pain Rating
Measured: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months
Secondary outcomes (1)
Change in Medication Intake (Frequency of pain medication)
Frequency of pain medication (narcotics and over-the counter drugs) required for low back / pelvic pain
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study start21 Feb 2015
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, DPT FAAOMPT, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373644
- Sponsor's protocol ID
- AAMT0004
- Status last verified
- Oct 2019
- First submitted
- 10 Feb 2015
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction: a Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02373644
- Acronym / sponsor ID
- AAMT0004
- Conditions
- Sacroiliac Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 21 Feb 2015 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVLA Thrust Manipulation and DN | Experimental | Other: HVLA Thrust Manipulation and DN |
| Conventional Physical Therapy | Active comparator | Other: Conventional Physical Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient must report sacroiliac dysfunction, defined as:
- 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)
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HVLA Thrust Manipulation and DNHVLA 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. | Other | HVLA Thrust Manipulation and DN |
| Conventional Physical TherapyTherapeutic exercise and manual therapy, up to 10 sessions over 6 weeks. Patients may receive interferential current and moist heat. | Other | Conventional Physical Therapy |
Primary outcome
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
Change in Back Pain Intensity (NPRS)
Time frame: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months
Numeric Pain Rating
Change in Leg pain Intensity (NPRS)
Time frame: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months
Numeric Pain Rating
1 secondary outcome
Change in Medication Intake (Frequency of pain medication)
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Dunning, DPT FAAOMPT principal investigator
American Academy of Manipulative Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HVLA Thrust Manipulation and DN and Conventional Physical Therapy in people with Sacroiliac Joint Dysfunction, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disability (ODI) (time frame: Baseline, 2 Days, 2 Weeks, 6 Weeks, 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020; AzTrials last refreshed its copy on 2 Nov 2026.