Chronic Lower Back PainNCT01765777
Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
A study testing Osteopathic Manipulative Medicine and Phototherapy in people with Chronic Lower Back Pain, run by New York Institute of Technology at 1 site in United States.
Trial summary
The purpose of the research study entitled "Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients with Chronic Lower Back Pain" is to investigate the hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and phototherapy will provide greater pain relief for… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Lower Back Pain
- What is being tested?
- Osteopathic Manipulative Medicine and Phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 31 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18 - 65 years old
- Subjects with constant or intermittent nonspecific lower back pain for a minimum of three (3) months duration.
Who cannot join
- Prospective subjects with a diagnosis of the following potential underlying causes of lower back pain: ankylosing spondylitis, cancer or a history of a histologically demonstrated malignant carcinoma, cauda equine syndrome, herniated disc, spinal fracture, or spinal osteomyelitis.
- Prospective subjects who have undergone surgery of the lower back in the preceding three (3) months.
- Prospective subjects who have received worker's compensation in the preceding three (3) months, or are involved in litigation involving concerns of lower back.
- Prospective subjects who are pregnant.
- Prospective subjects who have been a patient receiving any osteopathic manipulative medicine (OMM) treatment at the clinical trial site in the previous three (3) months, or on greater than three (3) occasions in the preceding year.
- Prospective subjects who have ever been an employee at the clinical trial site.
Show all 9Show fewer
- Prospective subjects who have received spinal manipulation in the previous three (3) months, or on greater than three (3) occasions in the preceding year.
- Prospective subjects who are currently involved in a physical therapy rehabilitation program.
- Prospective subjects who have photosensitivity.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Institute of Technology
Old Westbury, New York, 11568
Hallie Zwibel, D.O, 516-686-3771, hzwibel@nyit.edu
Patricia S Kooyman, D.O.
About this study
The purpose of the research study entitled "Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients with Chronic Lower Back Pain" is to investigate the hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and phototherapy will provide greater pain relief for patients with chronic lower back pain, as compared with standard medical management or either treatment alone.
Read the detailed description
The research has demonstrated separately that phototherapy and osteopathic manipulative medicine (OMM) are effective in reducing chronic low back pain, However there has not been any research to evaluate whether the interaction of the two treatment approaches together can provide enhanced pain relief. In A Meta-analysis of the Efficacy of Phototherapy in Tissue Repair, Fulop et.al.(1) from the Department of Physical Therapy, School of Health Professions, New York Institute of Technology (NYIT) concluded that "phototherapy is a highly effective form of treatment for tissue repair, with stronger supporting evidence resulting from experimental animal studies than human studies" (Fulop, p. 695, 699). Further review of the literature by Fulop et. al. (2) focused on the question of pain relief in relation to phototherapy, and the conclusion was that pain from various etiologies can be effectively relieved by phototherapy. The U.S. Food and Drug Administration has cleared biostimulation lasers (a.k.a. low level laser therapy [LLLT], cold lasers, soft lasers, or laser acupuncture devices) for marketing as "adjunctive devices for the temporary relief of pain" (3). Thus, both health practitioners and the lay public have access to and may potentially obtain and use phototherapy devices manufactured by various companies. Other research protocols by Gur, A et. al. (4) and Djavid, GE et. al. (5) evaluated patients with chronic low back pain in relation to the combined effectiveness of low level laser therapy and exercise. These studies showed positive results with the combined approaches.
Osteopathic physicians utilize an approach to the treatment of patients called osteopathic manipulative medicine (OMM). The osteopathic physician will diagnose somatic dysfunction, and then treat the dysfunctions found with one or more of several OMM treatment approaches. The American Osteopathic Association (AOA) published in 2009 the "Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients with Low Back Pain." These guidelines are available both through the AOA and the Agency for Healthcare Research and Quality (AHRQ), National Guideline Clearinghouse (6). This guideline (6) specifically addresses the "efficacy of osteopathic manipulation treatment in reducing low back pain" (p. 2). A review of the literature was performed, and after selection a total of "six trials, involving eight osteopathic manipulative treatment (OMT) vs control treatment comparisons, were included" in the meta-analysis (p. 2-3). The major recommendation stated in the guideline is that "osteopathic manipulative treatment (OMT) be utilized by osteopathic physicians for musculoskeletal causes of back pain, i.e., to treat the diagnoses of somatic dysfunctions related to the low back pain" (p.4). In addition, the meta-analysis performed did show that OMT for patients with low back pain led to statistically significant reduction in pain (p. 5). Thus, the potential for a complementary approach to patient care in cases of chronic low back pain exists. Yet, no studies to date have specifically evaluated this particular hypothesis regarding OMT and phototherapy for patients with chronic low back pain. The purpose of this research is to evaluate this question of enhanced combined efficacy for the overall benefit of patients.
- Conditions
- Chronic Lower Back Pain
- Being tested
- Osteopathic Manipulative Medicine, Phototherapy
- Keywords
- Low back pain, Lower back pain, Chronic back pain
- Medical subject headings
- Low Back 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
Also called OMM,OMT
PhototherapyProcedure or surgery
Also called Low level laser therapy, LLLT
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Subjects in this arm continue with standard medical care |
| Osteopathic Manipulative Medicine Group | Experimental | Subjects in this arm will receive an OMM intervention. Receives: Procedure: Osteopathic Manipulative Medicine |
| Phototherapy Group | Experimental | Subjects in this arm will receive a phototherapy intervention. Receives: Procedure: Phototherapy |
| OMM and Phototherapy Group | Experimental | Subjects in this arm will receive both the OMM and phototherapy interventions. Receives: Procedure: Osteopathic Manipulative Medicine; Procedure: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 cm visual analog scale for quantitative back pain
VAS Data collected at all visits
Measured: 8 weeks
SF-36 Health Survey to measure Quality of Life
SF-36 survey data collected at 3 points
Measured: 8 weeks
The Oswestry Back Questionnaire to measure qualitative back pain
Oswestry questionnaire data collected at 3 points
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJun 2011
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Chronic Lower 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia S Kooyman, D.O., Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765777
- Sponsor's protocol ID
- BHS-740
- Status last verified
- Aug 2024
- First submitted
- 8 Jan 2013
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of phototherapy in tissue repair. Photomed Laser Surg. 2009 Oct;27(5):695-702. doi: 10.1089/pho.2009.2550.
PubMed 19698019Gur A, Karakoc M, Cevik R, Nas K, Sarac AJ, Karakoc M. Efficacy of low power laser therapy and exercise on pain and functions in chronic low back pain. Lasers Surg Med. 2003;32(3):233-8. doi: 10.1002/lsm.10134.
PubMed 12605431Djavid GE, Mehrdad R, Ghasemi M, Hasan-Zadeh H, Sotoodeh-Manesh A, Pouryaghoub G. In chronic low back pain, low level laser therapy combined with exercise is more beneficial than exercise alone in the long term: a randomised trial. Aust J Physiother. 2007;53(3):155-60. doi: 10.1016/s0004-9514(07)70022-3.
PubMed 17725472Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J Jr. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1355-62. doi: 10.1097/01.BRS.0000067110.61471.7D.
PubMed 12838090Williams NH, Wilkinson C, Russell I, Edwards RT, Hibbs R, Linck P, Muntz R. Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care. Fam Pract. 2003 Dec;20(6):662-9. doi: 10.1093/fampra/cmg607.
PubMed 14701889Williams N. Managing back pain in general practice--is osteopathy the new paradigm? Br J Gen Pract. 1997 Oct;47(423):653-5.
PubMed 9474832Ferreira ML, Ferreira PH, Latimer J, Herbert RD, Hodges PW, Jennings MD, Maher CG, Refshauge KM. Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial. Pain. 2007 Sep;131(1-2):31-7. doi: 10.1016/j.pain.2006.12.008. Epub 2007 Jan 23.
PubMed 17250965Burton AK, McClune TD, Clarke RD, Main CJ. Long-term follow-up of patients with low back pain attending for manipulative care: outcomes and predictors. Man Ther. 2004 Feb;9(1):30-5. doi: 10.1016/s1356-689x(03)00052-3.
PubMed 14723859Harvey E, Burton AK, Moffett JK, Breen A; UK BEAM trial team. Spinal manipulation for low-back pain: a treatment package agreed to by the UK chiropractic, osteopathy and physiotherapy professional associations. Man Ther. 2003 Feb;8(1):46-51. doi: 10.1054/math.2002.0472.
PubMed 12635637Kimberly PE. Formulating a prescription for osteopathic manipulative treatment. J Am Osteopath Assoc. 1980 Apr;79(8):506-13. No abstract available.
PubMed 7364595Ramirez MA, Haman J, Worth L. Low back pain: diagnosis by six newly discovered sacral tender points and treatment with counterstrain. J Am Osteopath Assoc. 1989 Jul;89(7):905-6, 911-3.
PubMed 2527838Hoffman KS, Hoffman LL. Effects of adding sacral base leveling to osteopathic manipulative treatment of back pain: a pilot study. J Am Osteopath Assoc. 1994 Mar;94(3):217-20, 223-6.
PubMed 8200825Jokl P. Twenty-eighth annual AOA/NOF Research Conference, 1984: part I. Keynote address: Muscle and low-back pain. J Am Osteopath Assoc. 1984 Sep;84(1):64-6. No abstract available.
PubMed 6238015Hoyt WH, Bard DA, Shaffer F. Experience with an antigravity leverage device for chronic low back pain: a clinical study. J Am Osteopath Assoc. 1981 Mar;80(7):474-9. No abstract available.
PubMed 6453859Korr IM. The spinal cord as organizer of disease processes: IV. Axonal transport and neurotrophic function in relation to somatic dysfunction. J Am Osteopath Assoc. 1981 Mar;80(7):451-9. No abstract available.
PubMed 6263830
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
- ClinicalTrials.gov ID
- NCT01765777
- Acronym / sponsor ID
- BHS-740
- Conditions
- Chronic Lower Back Pain
- Keywords
- Low back pain, Lower back pain, Chronic back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jan 2013 (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 study entitled "Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients with Chronic Lower Back Pain" is to investigate the hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and phototherapy will provide greater pain relief for patients with chronic lower back pain, as compared with standard medical management or either treatment alone.
Detailed description
The research has demonstrated separately that phototherapy and osteopathic manipulative medicine (OMM) are effective in reducing chronic low back pain, However there has not been any research to evaluate whether the interaction of the two treatment approaches together can provide enhanced pain relief. In A Meta-analysis of the Efficacy of Phototherapy in Tissue Repair, Fulop et.al.(1) from the Department of Physical Therapy, School of Health Professions, New York Institute of Technology (NYIT) concluded that "phototherapy is a highly effective form of treatment for tissue repair, with stronger supporting evidence resulting from experimental animal studies than human studies" (Fulop, p. 695, 699). Further review of the literature by Fulop et. al. (2) focused on the question of pain relief in relation to phototherapy, and the conclusion was that pain from various etiologies can be effectively relieved by phototherapy. The U.S. Food and Drug Administration has cleared biostimulation lasers (a.k.a. low level laser therapy [LLLT], cold lasers, soft lasers, or laser acupuncture devices) for marketing as "adjunctive devices for the temporary relief of pain" (3). Thus, both health practitioners and the lay public have access to and may potentially obtain and use phototherapy devices manufactured by various companies. Other research protocols by Gur, A et. al. (4) and Djavid, GE et. al. (5) evaluated patients with chronic low back pain in relation to the combined effectiveness of low level laser therapy and exercise. These studies showed positive results with the combined approaches.
Osteopathic physicians utilize an approach to the treatment of patients called osteopathic manipulative medicine (OMM). The osteopathic physician will diagnose somatic dysfunction, and then treat the dysfunctions found with one or more of several OMM treatment approaches. The American Osteopathic Association (AOA) published in 2009 the "Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients with Low Back Pain." These guidelines are available both through the AOA and the Agency for Healthcare Research and Quality (AHRQ), National Guideline Clearinghouse (6). This guideline (6) specifically addresses the "efficacy of osteopathic manipulation treatment in reducing low back pain" (p. 2). A review of the literature was performed, and after selection a total of "six trials, involving eight osteopathic manipulative treatment (OMT) vs control treatment comparisons, were included" in the meta-analysis (p. 2-3). The major recommendation stated in the guideline is that "osteopathic manipulative treatment (OMT) be utilized by osteopathic physicians for musculoskeletal causes of back pain, i.e., to treat the diagnoses of somatic dysfunctions related to the low back pain" (p.4). In addition, the meta-analysis performed did show that OMT for patients with low back pain led to statistically significant reduction in pain (p. 5). Thus, the potential for a complementary approach to patient care in cases of chronic low back pain exists. Yet, no studies to date have specifically evaluated this particular hypothesis regarding OMT and phototherapy for patients with chronic low back pain. The purpose of this research is to evaluate this question of enhanced combined efficacy for the overall benefit of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subjects in this arm continue with standard medical care |
| Osteopathic Manipulative Medicine Group | Experimental | Procedure: Osteopathic Manipulative MedicineSubjects in this arm will receive an OMM intervention. |
| Phototherapy Group | Experimental | Procedure: PhototherapySubjects in this arm will receive a phototherapy intervention. |
| OMM and Phototherapy Group | Experimental | Procedure: Osteopathic Manipulative Medicine, Procedure: PhototherapySubjects in this arm will receive both the OMM and phototherapy interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age range: 18 - 65 years old
- Subjects with constant or intermittent nonspecific lower back pain for a minimum of three (3) months duration.
Key exclusion criteria (9 listed)
- Prospective subjects with a diagnosis of the following potential underlying causes of lower back pain: ankylosing spondylitis, cancer or a history of a histologically demonstrated malignant carcinoma, cauda equine syndrome, herniated disc, spinal fracture, or spinal osteomyelitis.
- Prospective subjects who have undergone surgery of the lower back in the preceding three (3) months.
- Prospective subjects who have received worker's compensation in the preceding three (3) months, or are involved in litigation involving concerns of lower back.
- Prospective subjects who are pregnant.
- Prospective subjects who have been a patient receiving any osteopathic manipulative medicine (OMM) treatment at the clinical trial site in the previous three (3) months, or on greater than three (3) occasions in the preceding year.
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 MedicineAlso: OMM,OMT | Procedure or surgery | OMM and Phototherapy Group, Osteopathic Manipulative Medicine Group |
| PhototherapyAlso: Low level laser therapy, LLLT | Procedure or surgery | OMM and Phototherapy Group, Phototherapy Group |
Primary outcome
10 cm visual analog scale for quantitative back pain
Time frame: 8 weeks
VAS Data collected at all visits
SF-36 Health Survey to measure Quality of Life
Time frame: 8 weeks
SF-36 survey data collected at 3 points
The Oswestry Back Questionnaire to measure qualitative back pain
Time frame: 8 weeks
Oswestry questionnaire data collected at 3 points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 19698019Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of phototherapy in tissue repair. Photomed Laser Surg. 2009 Oct;27(5):695-702. doi: 10.1089/pho.2009.2550.
- Background: PubMed 12605431Gur A, Karakoc M, Cevik R, Nas K, Sarac AJ, Karakoc M. Efficacy of low power laser therapy and exercise on pain and functions in chronic low back pain. Lasers Surg Med. 2003;32(3):233-8. doi: 10.1002/lsm.10134.
- Background: PubMed 17725472Djavid GE, Mehrdad R, Ghasemi M, Hasan-Zadeh H, Sotoodeh-Manesh A, Pouryaghoub G. In chronic low back pain, low level laser therapy combined with exercise is more beneficial than exercise alone in the long term: a randomised trial. Aust J Physiother. 2007;53(3):155-60. doi: 10.1016/s0004-9514(07)70022-3.
- Background: PubMed 12838090Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J Jr. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1355-62. doi: 10.1097/01.BRS.0000067110.61471.7D.
- Background: PubMed 14701889Williams NH, Wilkinson C, Russell I, Edwards RT, Hibbs R, Linck P, Muntz R. Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care. Fam Pract. 2003 Dec;20(6):662-9. doi: 10.1093/fampra/cmg607.
- Background: PubMed 9474832Williams N. Managing back pain in general practice--is osteopathy the new paradigm? Br J Gen Pract. 1997 Oct;47(423):653-5.
- Background: PubMed 17250965Ferreira ML, Ferreira PH, Latimer J, Herbert RD, Hodges PW, Jennings MD, Maher CG, Refshauge KM. Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial. Pain. 2007 Sep;131(1-2):31-7. doi: 10.1016/j.pain.2006.12.008. Epub 2007 Jan 23.
- Background: PubMed 14723859Burton AK, McClune TD, Clarke RD, Main CJ. Long-term follow-up of patients with low back pain attending for manipulative care: outcomes and predictors. Man Ther. 2004 Feb;9(1):30-5. doi: 10.1016/s1356-689x(03)00052-3.
- Background: PubMed 12635637Harvey E, Burton AK, Moffett JK, Breen A; UK BEAM trial team. Spinal manipulation for low-back pain: a treatment package agreed to by the UK chiropractic, osteopathy and physiotherapy professional associations. Man Ther. 2003 Feb;8(1):46-51. doi: 10.1054/math.2002.0472.
- Background: PubMed 7364595Kimberly PE. Formulating a prescription for osteopathic manipulative treatment. J Am Osteopath Assoc. 1980 Apr;79(8):506-13. No abstract available.
- Background: PubMed 2527838Ramirez MA, Haman J, Worth L. Low back pain: diagnosis by six newly discovered sacral tender points and treatment with counterstrain. J Am Osteopath Assoc. 1989 Jul;89(7):905-6, 911-3.
- Background: PubMed 8200825Hoffman KS, Hoffman LL. Effects of adding sacral base leveling to osteopathic manipulative treatment of back pain: a pilot study. J Am Osteopath Assoc. 1994 Mar;94(3):217-20, 223-6.
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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.
Patricia S Kooyman, D.O. principal investigator
New York Institute of Technology
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 and Phototherapy in people with Chronic Lower Back Pain, run by New York Institute of Technology 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 2 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia S Kooyman, D.O. (516-686-1309, pkooyman@nyit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 cm visual analog scale for quantitative back pain (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT01765777, which also lists 32 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 6 Aug 2024.