Low Back PainD2P3NCT00830596

Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients

A study testing HVLA-SM and LVVA-SM in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Low Back Pain
What is being tested?: HVLA-SM and LVVA-SM
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 221 participants
Where: 1 siteUnited States
Study dates: Jul 2007to Jul 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

21 to 65 years old
Low back pain (LBP) score an 11 point numerical rating scale: (must be > 4 at the Phone Screening OR Baseline 1 Visit) AND (must be > 2 at the Phone Screen, Baseline 1 AND Baseline 2 Visits)
Acute (less than 7 days), sub-acute (7 days to 7 weeks), or chronic (more than 7 weeks) LBP matching classifications 1, 2, or 3 of the Quebec Task Force (QTF) Classification system - QTF 1: Pain without radiation, QTF 2: Pain + radiation to proximal extremity, QTF 3: Pain + radiation to distal extremity, QTF 7: Spinal stenosis
Written informed consent (ICD1, ICD2 and ICD3)

Who cannot join

Ongoing treatment for low back pain by other health care providers - unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy and massage) for the duration of the study period.
Co-morbidities Bleeding Disorders Bone and Joint Pathology Cauda Equina Syndrome Contra-indication to spinal manipulation, in general Current or Pending Litigation General Poor Health Inflammatory or Destructive tissue changes to the spine Neuromuscular Diseases Obesity Osteoporosis Peripheral Neuropathies Spinal Surgery Suspicion of drug or alcohol abuse Uncontrolled hypertension Vascular claudication
Quebec Task Force (QTF) on Spinal Disorders QTF 4: Pain + radiation to upper/lower limb with neurologic signs QTF 5: Presumptive compression of a spinal nerve root on a simple roentgenogram QTF 6: Compression of a spinal nerve root confirmed by specific imaging techniques QTF 8: Postsurgical status, 1-6 months after intervention QTF 9: Postsurgical status, >6 months after intervention 9.1: Asymptomatic 9.2: Symptomatic QTF 10: Chronic pain syndrome QTF 11: Other diagnoses
Pregnant or nursing women
Pacemaker
Inability to read or verbally comprehend English

Show all 12Show fewer

Any Joint Replacement
Use of spinal manipulation within the past 4 weeks. If participants are willing to delay study enrollment until four weeks post spinal manipulative therapy, then we will schedule accordingly until this criterion is met
Sensitivity to tape used during the biomechanical assessments
If the Study Clinician believes that diagnostic procedures other than x-rays or dipstick urinalysis are necessary to diagnose a participant's condition, then the participant will be excluded
Beck Depression Inventory-II greater than or equal to 29
Retention of legal advice and an open or pending case for a health-related condition

Trial locations and contacts

1 site in 1 country.

United States1 site

Palmer College of Chiropractic
Davenport, Iowa, 52803

Other trials in United States

About this study

The long-term goal for this study is to understand the physiological mechanisms of various forms of spinal manipulation in order to refine and improve this therapy for appropriately selected patients. The objective of this study is to assess the effects of high-velocity low-amplitude spinal manipulation and low-velocity variable amplitude spinal manipulation on three types of sensorimotor abilities in patients with low back pain.

Read the detailed description

In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will pursue the following specific aim: To determine the effects of 2 weeks (4 applications @ 2 per week) of HVLA-SM and LVVA-SM to the lumbo-pelvic region, compared to a control group receiving light effleurage and a sham mechanically assisted adjustment, on sensorimotor function as measured by: lumbo-pelvic repositioning ability, standing postural sway and response to sudden trunk loading;

Conditions: Low Back Pain
Being tested: HVLA-SM, LVVA-SM, Sham Intervention
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.

HVLA-SMOther
High velocity, low amplitude lumbo-pelvic manipulation
LVVA-SMOther
Low velocity, variable amplitude lumbo-pelvic manipulation
Sham InterventionOther
Also called light effleurage followed by SMT
2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation

Study groups in NCT00830596
Study group	Role	What they receive
HVLA-SM	Active comparator	High velocity, low amplitude lumbo-pelvic manipulation Receives: Other: HVLA-SM
LVVA-SM	Active comparator	Low velocity, variable amplitude lumbo-pelvic manipulation Receives: Other: LVVA-SM
Sham Intervention	Placebo comparator	Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks Receives: Other: Sham Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Postural Sway
Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:
Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction.
Measured: Baseline and 2 weeks
Postural Sway Speed
Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:
Sway Speed=overall center of pressure traveling distance divided by time.
Measured: Baseline and 2 weeks
Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL
Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load [RTSL], ant. COP=anterior movement in center of pressure
Measured: Baseline and 2 weeks
Response to Sudden Load, Peak Muscle Response Per Side
Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)
Measured: Baseline and 2 weeks
Response to Sudden Load Response Times
Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)
Measured: Baseline and 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Jul 2012

First posted28 Jan 2009 (estimated)
Study startJul 2007
Primary completionJun 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)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: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00830596
Sponsor's protocol ID: D2P3
Other IDs: U19AT004137
Acronym: D2P3
Status last verified: Jul 2017
First submitted: 27 Jan 2009
Last updated: 25 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Once the resulting manuscripts have been published, data sets will be provided for public access. Potential investigators can contact one of the Co-PIs to present their hypothesis, study design, instruments and/or data on which to focus, and resources required. Depending upon the needs and desires of the requesting party, the data that are shared may include analytic tables or de-identified or limited data sets that are transmitted to the requesting parties for additional analyses.

Publications

Wilder DG, Vining RD, Pohlman KA, Meeker WC, Xia T, Devocht JW, Gudavalli RM, Long CR, Owens EF, Goertz CM. Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial. Trials. 2011 Jun 28;12:161. doi: 10.1186/1745-6215-12-161.
PubMed 21708042
Vining RD, Salsbury SA, Pohlman KA. Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. Trials. 2014 Oct 24;15:406. doi: 10.1186/1745-6215-15-406.
PubMed 25344427
Vining R, Potocki E, Seidman M, Morgenthal AP. An evidence-based diagnostic classification system for low back pain. J Can Chiropr Assoc. 2013 Sep;57(3):189-204.
PubMed 23997245
Goertz CM, Xia T, Long CR, Vining RD, Pohlman KA, DeVocht JW, Gudavalli MR, Owens EF Jr, Meeker WC, Wilder DG. Effects of spinal manipulation on sensorimotor function in low back pain patients--A randomised controlled trial. Man Ther. 2016 Feb;21:183-90. doi: 10.1016/j.math.2015.08.001. Epub 2015 Aug 8.
PubMed 26319101
Vining RD, Potocki E, McLean I, Seidman M, Morgenthal AP, Boysen J, Goertz C. Prevalence of radiographic findings in individuals with chronic low back pain screened for a randomized controlled trial: secondary analysis and clinical implications. J Manipulative Physiol Ther. 2014 Nov-Dec;37(9):678-87. doi: 10.1016/j.jmpt.2014.10.003. Epub 2014 Nov 1.
PubMed 25455834

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients
ClinicalTrials.gov ID: NCT00830596
Acronym / sponsor ID: D2P3 / D2P3
Conditions: Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: Palmer College of ChiropracticUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Jul 2007
Primary completion: Jun 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 28 Jan 2009 (estimated)
Results: Posted 25 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
HVLA-SM	Active comparator	Other: HVLA-SMHigh velocity, low amplitude lumbo-pelvic manipulation
LVVA-SM	Active comparator	Other: LVVA-SMLow velocity, variable amplitude lumbo-pelvic manipulation
Sham Intervention	Placebo comparator	Other: Sham InterventionLight effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

21 to 65 years old
Low back pain (LBP) score an 11 point numerical rating scale: (must be > 4 at the Phone Screening OR Baseline 1 Visit) AND (must be > 2 at the Phone Screen, Baseline 1 AND Baseline 2 Visits)
Acute (less than 7 days), sub-acute (7 days to 7 weeks), or chronic (more than 7 weeks) LBP matching classifications 1, 2, or 3 of the Quebec Task Force (QTF) Classification system - QTF 1: Pain without radiation, QTF 2: Pain + radiation to proximal extremity, QTF 3: Pain + radiation to distal extremity, QTF 7: Spinal stenosis
Written informed consent (ICD1, ICD2 and ICD3)

Key exclusion criteria (12 listed)

Ongoing treatment for low back pain by other health care providers - unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy and massage) for the duration of the study period.
Co-morbidities Bleeding Disorders Bone and Joint Pathology Cauda Equina Syndrome Contra-indication to spinal manipulation, in general Current or Pending Litigation General Poor Health Inflammatory or Destructive tissue changes to the spine Neuromuscular Diseases Obesity Osteoporosis Peripheral Neuropathies Spinal Surgery Suspicion of drug or alcohol abuse Uncontrolled hypertension Vascular claudication
Quebec Task Force (QTF) on Spinal Disorders QTF 4: Pain + radiation to upper/lower limb with neurologic signs QTF 5: Presumptive compression of a spinal nerve root on a simple roentgenogram QTF 6: Compression of a spinal nerve root confirmed by specific imaging techniques QTF 8: Postsurgical status, 1-6 months after intervention QTF 9: Postsurgical status, >6 months after intervention 9.1: Asymptomatic 9.2: Symptomatic QTF 10: Chronic pain syndrome QTF 11: Other diagnoses
Pregnant or nursing women
Pacemaker

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-SMHigh velocity, low amplitude lumbo-pelvic manipulation	Other	HVLA-SM
LVVA-SMLow velocity, variable amplitude lumbo-pelvic manipulation	Other	LVVA-SM
Sham InterventionAlso: light effleurage followed by SMT2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation	Other	Sham Intervention

Primary outcome

Postural Sway
Time frame: Baseline and 2 weeks
Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction.
Postural Sway Speed
Time frame: Baseline and 2 weeks
Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Sway Speed=overall center of pressure traveling distance divided by time.
Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL
Time frame: Baseline and 2 weeks
Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load [RTSL], ant. COP=anterior movement in center of pressure
Response to Sudden Load, Peak Muscle Response Per Side
Time frame: Baseline and 2 weeks
Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)
Response to Sudden Load Response Times
Time frame: Baseline and 2 weeks
Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)

Results and safety

Results posted to the registry on 25 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HVLA-SM	74	72
LVVA-SM	74	72
Sham Intervention	73	67

Primary outcome: Postural Sway

Time frame: Baseline and 2 weeks. Mean (95% Confidence Interval). Unit: mm

Measure	HVLA-SM n = 74	LVVA-SM n = 74	Sham Intervention n = 73
Postural Sway_AP excursion - Hard (mm)	-.13 (-0.60 to 0.35)	-0.26 (-0.75 to 0.22)	-0.18 (-0.66 to 0.30)
Postural Sway_ML excursion - Hard (mm)	-0.06 (-0.25 to 0.14)	-0.06 (-0.26 to 0.14)	-0.11 (-0.31 to 0.09)
Postural Sway_AP excursion - Soft (mm)	-0.03 (-0.63 to 0.56)	0.02 (-0.58 to 0.63)	-0.26 (-0.87 to 0.34)
Postural Sway_ML excursion - Soft (mm)	0.53 (0.09 to 0.98)	0.51 (0.06 to 0.96)	0.2 (-0.25 to 0.64)

Primary outcome: Postural Sway Speed

Time frame: Baseline and 2 weeks. Mean (95% Confidence Interval). Unit: mm/s

Measure	HVLA-SM n = 74	LVVA-SM n = 74	Sham Intervention n = 73
Postural Sway_ Sway speed - Hard (mm/s)	0.02 (-1.14 to 1.18)	-0.11 (-1.29 to 1.07)	-0.23 (-1.40 to 0.94)
Postural Sway_Sway speed - Soft (mm/s)	-0.40 (-2.53 to 1.74)	-1.71 (-3.87 to 0.46)	-0.94 (-3.10 to 1.21)

Primary outcome: Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL

Time frame: Baseline and 2 weeks. Mean (95% Confidence Interval). Unit: mm

Measure	HVLA-SM n = 74	LVVA-SM n = 74	Sham Intervention n = 73
Value	-4.7 (-7.9 to 1.5)	-4.1 (-7.4 to 0.7)	-5.8 (-9.2 to -2.4)

Primary outcome: Response to Sudden Load, Peak Muscle Response Per Side

Time frame: Baseline and 2 weeks. Mean (95% Confidence Interval). Unit: % muscle response

Measure	HVLA-SM n = 74	LVVA-SM n = 74	Sham Intervention n = 73
RTSL_Norm. peak muscle response - L (%)	-11.4 (-21.7 to -1.2)	5.2 (-5.0 to 15.4)	0.1 (-10.0 to 10.2)
RTSL_Norm. peak muscle response - R (%)	3.4 (-3.0 to 9.8)	1.4 (-5.2 to 8.0)	-1.2 (-7.8 to 5.3)

Adverse events

Time frame: 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HVLA-SM*	0 of 74 (0%)	50 of 74 (67.6%)	0 of 74
LVVA-SM*	0 of 74 (0%)	57 of 74 (77%)	0 of 74
Sham Intervention*	0 of 73 (0%)	46 of 73 (63%)	0 of 73

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21708042Wilder DG, Vining RD, Pohlman KA, Meeker WC, Xia T, Devocht JW, Gudavalli RM, Long CR, Owens EF, Goertz CM. Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial. Trials. 2011 Jun 28;12:161. doi: 10.1186/1745-6215-12-161.
Background: PubMed 25344427Vining RD, Salsbury SA, Pohlman KA. Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. Trials. 2014 Oct 24;15:406. doi: 10.1186/1745-6215-15-406.
Background: PubMed 23997245Vining R, Potocki E, Seidman M, Morgenthal AP. An evidence-based diagnostic classification system for low back pain. J Can Chiropr Assoc. 2013 Sep;57(3):189-204.
Results publication: PubMed 26319101Goertz CM, Xia T, Long CR, Vining RD, Pohlman KA, DeVocht JW, Gudavalli MR, Owens EF Jr, Meeker WC, Wilder DG. Effects of spinal manipulation on sensorimotor function in low back pain patients--A randomised controlled trial. Man Ther. 2016 Feb;21:183-90. doi: 10.1016/j.math.2015.08.001. Epub 2015 Aug 8.
Results publication: PubMed 25455834Vining RD, Potocki E, McLean I, Seidman M, Morgenthal AP, Boysen J, Goertz C. Prevalence of radiographic findings in individuals with chronic low back pain screened for a randomized controlled trial: secondary analysis and clinical implications. J Manipulative Physiol Ther. 2014 Nov-Dec;37(9):678-87. doi: 10.1016/j.jmpt.2014.10.003. Epub 2014 Nov 1.
Individual participant dataSharing planned: Yes. Once the resulting manuscripts have been published, data sets will be provided for public access. Potential investigators can contact one of the Co-PIs to present their hypothesis, study design, instruments and/or data on which to focus, and resources required. Depending upon the needs and desires of the requesting party, the data that are shared may include analytic tables or de-identified or limited data sets that are transmitted to the requesting parties for additional analyses.

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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.

Christine Goertz, DC, PhD principal investigator

Palmer College of Chiropractic

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-SM and LVVA-SM in people with Low Back Pain, run by Palmer 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 4 inclusion and 12 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 25 Sep 2017. 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?

Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Postural Sway (time frame: Baseline and 2 weeks). The study lists 5 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 NCT00830596, which also lists 5 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 25 Sep 2017.