Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients (D2P3)
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| ClinicalTrials.gov Identifier: NCT00830596 |
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Recruitment Status
:
Completed
First Posted
: January 28, 2009
Results First Posted
: September 25, 2017
Last Update Posted
: September 25, 2017
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Sponsor:
Palmer College of Chiropractic
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Palmer College of Chiropractic
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Low Back Pain | Other: HVLA-SM Other: LVVA-SM Other: Sham Intervention | Not Applicable |
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;
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 221 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients |
| Study Start Date : | July 2007 |
| Actual Primary Completion Date : | June 2012 |
| Actual Study Completion Date : | July 2012 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: HVLA-SM
High velocity, low amplitude lumbo-pelvic manipulation
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Other: HVLA-SM
High velocity, low amplitude lumbo-pelvic manipulation
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Active Comparator: LVVA-SM
Low velocity, variable amplitude lumbo-pelvic manipulation
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Other: LVVA-SM
Low velocity, variable amplitude lumbo-pelvic manipulation
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Placebo Comparator: Sham Intervention
Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks
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Other: Sham Intervention
2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
Other Name: light effleurage followed by SMT
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Primary Outcome Measures
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- 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)
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| Ages Eligible for Study: | 21 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830596
Locations
| United States, Iowa | |
| Palmer College of Chiropractic | |
| Davenport, Iowa, United States, 52803 | |
Sponsors and Collaborators
Palmer College of Chiropractic
National Center for Complementary and Integrative Health (NCCIH)
Investigators
| Principal Investigator: | Christine Goertz, DC, PhD | Palmer College of Chiropractic |
Publications of Results:
Other Publications:
| Responsible Party: | Palmer College of Chiropractic |
| ClinicalTrials.gov Identifier: | NCT00830596 History of Changes |
| Other Study ID Numbers: |
D2P3 U19AT004137 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 28, 2009 Key Record Dates |
| Results First Posted: | September 25, 2017 |
| Last Update Posted: | September 25, 2017 |
| Last Verified: | July 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
Additional relevant MeSH terms:
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Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |