Sacroiliac FunctionNCT00758888
Effect of Orthopedic Blocking on Cervical Spine Flexion and Extension Strength
A study testing Orthopedic Blocking and Trochanter Belt in people with Sacroiliac Function, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
A few studies concerning the effects of joint manipulation have shown muscle responses distal to the site of manipulation. The purpose of this study is to determine if pelvic orthopedic blocking, a low force method of manipulating the sacroiliac joint, can have produce changes to cervical spine function. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Function
- What is being tested?
- Orthopedic Blocking and Trochanter Belt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Oct 2008
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Logan faculty, students, or staff 18-30 years of age with a leg-length inequality of 5mm or more.
Who cannot join
- Fractures
- Tumors
- Myopathies
- Consumption of prescription drugs that affect nervous system function
- Recent cervical spine injuries or surgeries
- Cervical pain
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Logan College of Chiropractic
Chesterfield, Missouri, 63006
About this study
A few studies concerning the effects of joint manipulation have shown muscle responses distal to the site of manipulation. The purpose of this study is to determine if pelvic orthopedic blocking, a low force method of manipulating the sacroiliac joint, can have produce changes to cervical spine function.
Read the detailed description
All mechanoreceptor types are found in diarthrodial joints. Mechanoreceptor afferents have reflexive connections to motor neurons. Stimulation of muscle and joint afferents are known to produce reflexive muscle changes. Orthopedic blocking applies a gentle compression to the sacroiliac joints. The current study seeks to determine if orthopedic blocking of the sacroiliac joint can affect cervical spine function thereby serving as a useful adjunctive procedure in the treatment of cervical spine joint dysfunction. The current study will compare pre \& post treatment cervical isometric strength readings from an orthopedic blocking group, a trochanter belt group (another type of compression), and a sham group.
- Conditions
- Sacroiliac Function
- Being tested
- Orthopedic Blocking, Trochanter Belt, Blocking Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopedic BlockingProcedure or surgery
Place the blocks under the pelvis for 2 minutes
Trochanter BeltProcedure or surgery
Participant is fitted with trochanter belt on the adjusting table and wear it while Investigator checks their flexion and extension strength.
Blocking ShamOther
Participant lies on adjusting table, blocks are placed in a similar configuration but distant to actual points of leverage.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Place the blocks under the pelvis for 2 minutes Receives: Procedure: Orthopedic Blocking |
| Trochanter Belt | Active comparator | Participant is fitted with trochanter belt on the adjusting table and wear it while Investigator checks their flexion and extension strength. Receives: Procedure: Trochanter Belt |
| Sham | Sham comparator | Participant lies on adjusting table, blocks are placed in a similar configuration but distant to actual points of leverage. Receives: Other: Blocking Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Isometric Strength
Measured: Pre and post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac FunctionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758888
- Sponsor's protocol ID
- RD0801080145
- Status last verified
- Sep 2008
- First submitted
- 23 Sep 2008
- Last updated
- 24 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Orthopedic Blocking on Cervical Spine Flexion and Extension Strength
- ClinicalTrials.gov ID
- NCT00758888
- Acronym / sponsor ID
- RD0801080145
- Conditions
- Sacroiliac Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 25 Sep 2008 (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.
A few studies concerning the effects of joint manipulation have shown muscle responses distal to the site of manipulation. The purpose of this study is to determine if pelvic orthopedic blocking, a low force method of manipulating the sacroiliac joint, can have produce changes to cervical spine function.
Detailed description
All mechanoreceptor types are found in diarthrodial joints. Mechanoreceptor afferents have reflexive connections to motor neurons. Stimulation of muscle and joint afferents are known to produce reflexive muscle changes. Orthopedic blocking applies a gentle compression to the sacroiliac joints. The current study seeks to determine if orthopedic blocking of the sacroiliac joint can affect cervical spine function thereby serving as a useful adjunctive procedure in the treatment of cervical spine joint dysfunction. The current study will compare pre \& post treatment cervical isometric strength readings from an orthopedic blocking group, a trochanter belt group (another type of compression), and a sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Orthopedic BlockingPlace the blocks under the pelvis for 2 minutes |
| Trochanter Belt | Active comparator | Procedure: Trochanter BeltParticipant is fitted with trochanter belt on the adjusting table and wear it while Investigator checks their flexion and extension strength. |
| Sham | Sham comparator | Other: Blocking ShamParticipant lies on adjusting table, blocks are placed in a similar configuration but distant to actual points of leverage. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Logan faculty, students, or staff 18-30 years of age with a leg-length inequality of 5mm or more.
Key exclusion criteria (6 listed)
- Fractures
- Tumors
- Myopathies
- Consumption of prescription drugs that affect nervous system function
- Recent cervical spine injuries or surgeries
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 |
|---|---|---|
| Orthopedic BlockingPlace the blocks under the pelvis for 2 minutes | Procedure or surgery | Treatment |
| Trochanter BeltParticipant is fitted with trochanter belt on the adjusting table and wear it while Investigator checks their flexion and extension strength. | Procedure or surgery | Trochanter Belt |
| Blocking ShamParticipant lies on adjusting table, blocks are placed in a similar configuration but distant to actual points of leverage. | Other | Sham |
Primary outcome
Cervical Isometric Strength
Time frame: Pre and post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2009.
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Comparative Effects of Autogenic Inhibition and Reciprocal Inhibition Technique on Pain, Functional Disability and Gait in Sacroiliac Joint Dysfuction.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthopedic Blocking and Trochanter Belt in people with Sacroiliac Function, run by Logan College of Chiropractic 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jul 2009. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristan Giggey, DC (636-230-1942 ext. 1942, Kristan.Giggey@logan.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Isometric Strength (time frame: Pre and post treatment). 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 24 Jul 2009.