Low Back PainNCT00410397
The Use of Manual Therapy to Treat Low-Back and Hip Pain
A study testing Osteopathic Manipulative Medicine in people with Low Back Pain and Pain, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial summary
Low back pain (LBP) is a common problem in the adult population with many approaches to treatment, but no clear answer. One of the causes of LBP, musculoskeletal pain, can be triggered by spasm of the deep muscles of the back and pelvis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Pain
- What is being tested?
- Osteopathic Manipulative Medicine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Feb 2007
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent
- Age-older than 18 years and younger than 65 years
- Lumbopelvic pain
Who cannot join
- Cardiovascular disease (heart-failure, myocardial infarction, hypertension)
- Diabetes
- Rheumatoid Arthritis
- Osteoarthritis
- Chronic Illness
- Pregnancy-self reported
Show all 10Show fewer
- Neurodegenerative Disease
- Osteopenia
- Osteoporosis
- Metastatic Cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University College of Osteopathic Medicine
Tulsa, Oklahoma, 74107
About this study
Official title: The Use of Myofascial Release in Lumbopelvic Pain
Low back pain (LBP) is a common problem in the adult population with many approaches to treatment, but no clear answer. One of the causes of LBP, musculoskeletal pain, can be triggered by spasm of the deep muscles of the back and pelvis. This study, therefore, focuses on treating pelvic muscle pain as a way of lessening LBP.
Read the detailed description
Osteopathic manipulative medicine (OMM) is a well-researched standard of care in the treatment of low back pain (LBP). Under the heading of OMM, many different modalities exist to decrease a patient's somatic dysfunction. Among the most commonly used are high velocity (thrusting through an immobilized joint) and muscle energy (engaging a restrictive barrier using the patient's own strength).
Although a very common complaint, there is no exact etiology for LBP. Many different theories exist, including postural disturbances, leg length discrepancies, and even genetic predispositions. A study in Spine finds that among those with chronic LBP there is a subgroup of people with reduced hip flexion, and concludes that hip motion should be considered in treatment of patients with LBP. Currently, there exists no research on the manipulation of hip flexors in the treatment of LBP. This study, therefore, will test the efficacy of OMM on the deep pelvic musculature as a way of decreasing LBP.
- Conditions
- Low Back Pain, Pain
- Being tested
- Osteopathic Manipulative Medicine, Sham Manipulation
- Keywords
- Low back pain, Hip pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative MedicineProcedure or surgery
Pelvic balancing, myofascial release of the anterior pelvis.
Sham ManipulationProcedure or surgery
Neutral positional, gentle palpation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Osteopathic Manipulative Medicine Receives: Procedure: Osteopathic Manipulative Medicine |
| B | Placebo comparator | Not described Receives: Procedure: Sham Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in low back pain on a 1-10 scale.
Measured: Immediately following treatment.
Secondary outcomes (2)
Reduction in low back pain on a 0-10 scale.
Measured: 6-8 hours after treatment.
Reduction in low back pain on a 0-10 scale.
Measured: After four weeks of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Corey R Babb, B.A., Principal investigator, Oklahoma State University College of Osteopathic MedicineJoAnn G Ryan, D.O., Study director, Oklahoma State University College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410397
- Sponsor's protocol ID
- 2006028
- Status last verified
- Jan 2008
- First submitted
- 11 Dec 2006
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
PubMed 16595438Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
PubMed 16080794Borenstein DG. Epidemiology, etiology, diagnostic evaluation, and treatment of low back pain. Curr Opin Rheumatol. 2001 Mar;13(2):128-34. doi: 10.1097/00002281-200103000-00006.
PubMed 11224737Hestbaek L, Leboeuf-Yde C, Kyvik KO. Is comorbidity in adolescence a predictor for adult low back pain? A prospective study of a young population. BMC Musculoskelet Disord. 2006 Mar 16;7:29. doi: 10.1186/1471-2474-7-29.
PubMed 16539740Hestbaek L, Larsen K, Weidick F, Leboeuf-Yde C. Low back pain in military recruits in relation to social background and previous low back pain. A cross-sectional and prospective observational survey. BMC Musculoskelet Disord. 2005 May 26;6:25. doi: 10.1186/1471-2474-6-25.
PubMed 15918894Porter JL, Wilkinson A. Lumbar-hip flexion motion. A comparative study between asymptomatic and chronic low back pain in 18- to 36-year-old men. Spine (Phila Pa 1976). 1997 Jul 1;22(13):1508-13; discussion 1513-4. doi: 10.1097/00007632-199707010-00017.
PubMed 9231971
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Myofascial Release in Lumbopelvic Pain
- ClinicalTrials.gov ID
- NCT00410397
- Acronym / sponsor ID
- 2006028
- Conditions
- Low Back Pain, Pain
- Keywords
- Low back pain, Hip pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 12 Dec 2006 (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.
Low back pain (LBP) is a common problem in the adult population with many approaches to treatment, but no clear answer. One of the causes of LBP, musculoskeletal pain, can be triggered by spasm of the deep muscles of the back and pelvis. This study, therefore, focuses on treating pelvic muscle pain as a way of lessening LBP.
Detailed description
Osteopathic manipulative medicine (OMM) is a well-researched standard of care in the treatment of low back pain (LBP). Under the heading of OMM, many different modalities exist to decrease a patient's somatic dysfunction. Among the most commonly used are high velocity (thrusting through an immobilized joint) and muscle energy (engaging a restrictive barrier using the patient's own strength).
Although a very common complaint, there is no exact etiology for LBP. Many different theories exist, including postural disturbances, leg length discrepancies, and even genetic predispositions. A study in Spine finds that among those with chronic LBP there is a subgroup of people with reduced hip flexion, and concludes that hip motion should be considered in treatment of patients with LBP. Currently, there exists no research on the manipulation of hip flexors in the treatment of LBP. This study, therefore, will test the efficacy of OMM on the deep pelvic musculature as a way of decreasing LBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Osteopathic Manipulative MedicineOsteopathic Manipulative Medicine |
| B | Placebo comparator | Procedure: Sham Manipulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Written informed consent
- Age-older than 18 years and younger than 65 years
- Lumbopelvic pain
Key exclusion criteria (10 listed)
- Cardiovascular disease (heart-failure, myocardial infarction, hypertension)
- Diabetes
- Rheumatoid Arthritis
- Osteoarthritis
- Chronic Illness
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 |
|---|---|---|
| Osteopathic Manipulative MedicinePelvic balancing, myofascial release of the anterior pelvis. | Procedure or surgery | A |
| Sham ManipulationNeutral positional, gentle palpation | Procedure or surgery | B |
Primary outcome
Reduction in low back pain on a 1-10 scale.
Time frame: Immediately following treatment.
2 secondary outcomes
Reduction in low back pain on a 0-10 scale.
Time frame: 6-8 hours after treatment.
Reduction in low back pain on a 0-10 scale.
Time frame: After four weeks of therapy.
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 15 Jan 2008.
- Background: PubMed 16595438Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
- Background: PubMed 16080794Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
- Background: PubMed 11224737Borenstein DG. Epidemiology, etiology, diagnostic evaluation, and treatment of low back pain. Curr Opin Rheumatol. 2001 Mar;13(2):128-34. doi: 10.1097/00002281-200103000-00006.
- Background: PubMed 16539740Hestbaek L, Leboeuf-Yde C, Kyvik KO. Is comorbidity in adolescence a predictor for adult low back pain? A prospective study of a young population. BMC Musculoskelet Disord. 2006 Mar 16;7:29. doi: 10.1186/1471-2474-7-29.
- Background: PubMed 15918894Hestbaek L, Larsen K, Weidick F, Leboeuf-Yde C. Low back pain in military recruits in relation to social background and previous low back pain. A cross-sectional and prospective observational survey. BMC Musculoskelet Disord. 2005 May 26;6:25. doi: 10.1186/1471-2474-6-25.
- Background: PubMed 9231971Porter JL, Wilkinson A. Lumbar-hip flexion motion. A comparative study between asymptomatic and chronic low back pain in 18- to 36-year-old men. Spine (Phila Pa 1976). 1997 Jul 1;22(13):1508-13; discussion 1513-4. doi: 10.1097/00007632-199707010-00017.
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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.
Corey R Babb, B.A. principal investigator
Oklahoma State University College of Osteopathic Medicine
JoAnn G Ryan, D.O. study director
Oklahoma State University College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Medicine in people with Low Back Pain and Pain, run by Oklahoma State University Center for Health Sciences 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 3 inclusion and 10 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 15 Jan 2008. 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?
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?
Reduction in low back pain on a 1-10 scale. (time frame: Immediately following treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00410397, which also lists 6 linked publications.
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 15 Jan 2008.