Archive for category Activator IV

Manual and Instrument Applied Cervical Manipulation for Mechanical Neck Pain: A Randomized Controlled Trial.

August 29, 2016 Activator IV, Cervical Spine, Clinical Trials,

Dr. Fuhr’s Commentary

This is now the fourth clinical trial published since 1996 comparing Activator-assisted manipulation to manual thrust manipulation for neck pain. Overall, it is a well designed study. However, the results are inconsistent with the findings from three previous clinical trials which reported that manual-thrust manipulation and Activator-assisted manipulation were equally effective in the treatment of neck pain.

Strengths: All Instrument-assisted manipulations were administered using an Activator IV instrument on a setting of “2” with the manipulative force delivered to the pedicle-lamina junction of the involved segment in an anterior, superior, and slightly medial line of drive. Furthermore, the manipulations were administered by a practitioner with 29 years of clinical experience in instrument manipulation.

Weaknesses: In this trial, the instrument was used only as a biomechanical device, and no Activator Method analytical protocols were used. The choice of which level of the cervical spine to address was at the discretion of the clinician following static palpation. Also, each type of treatment was delivered by a single clinician, and it is possible that part of the treatment response was due to indirect contextual factors related to participant-provider interaction, rather than the direct effect of the treatment alone.

The results are not definitive, and further research investigating the nature of these changes is warranted, but I applaud the efforts of my Australian research colleagues.

Abstract

OBJECTIVE:

The purpose of this study was to compare the effects of 2 different cervical manipulation techniques for mechanical neck pain (MNP).

METHODS:

Participants with MNP of at least 1 month’s duration (n = 65) were randomly allocated to 3 groups: (1) stretching (control), (2) stretching plus manually applied manipulation (MAM), and (3) stretching plus instrument-applied manipulation (IAM). MAM consisted of a single high-velocity, low-amplitude cervical chiropractic manipulation, whereas IAM involved the application of a single cervical manipulation using an (Activator IV) adjusting instrument. Preintervention and postintervention measurements were taken of all outcomes measures. Pain was the primary outcome and was measured using visual analogue scale and pressure pain thresholds. Secondary outcomes included cervical range of motion, hand grip-strength, and wrist blood pressure. Follow-up subjective pain scores were obtained via telephone text message 7 days postintervention.

RESULTS:

Subjective pain scores decreased at 7-day follow-up in the MAM group compared with control (P = .015). Cervical rotation bilaterally (ipsilateral: P = .002; contralateral: P = .015) and lateral flexion on the contralateral side to manipulation (P = .001) increased following MAM. Hand grip-strength on the contralateral side to manipulation (P = .013) increased following IAM. No moderate or severe adverse events were reported. Mild adverse events were reported on 6 occasions (control, 4; MAM, 1; IAM, 1).

CONCLUSION:

This study demonstrates that a single cervical manipulation is capable of producing immediate and short-term benefits for MNP. The study also demonstrates that not all manipulative techniques have the same effect and that the differences may be mediated by neurological or biomechanical factors inherent to each technique.

J Manipulative Physiol Ther. 2016 Jun;39(5):319-29. [PMID: 27180949]

Author information: Gorrell LM, Beath K, Engel RM.  Macquarie University, Sydney, NSW, Australia.

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Manual and Instrument Applied Cervical Manipulation for Mechanical Neck Pain: A Randomized Controlled Trial.

June 1, 2016 Activator IV, Cervical Spine, Clinical Trials,

Dr. Fuhr’s Commentary

This is now the fourth clinical trial published since 1996 comparing Activator-assisted manipulation to manual thrust manipulation for neck pain. Overall, it is a well designed study. However, the results are inconsistent with the findings from three previous clinical trials which reported that manual-thrust manipulation and Activator-assisted manipulation were equally effective in the treatment of neck pain.

Strengths: All instrument-assisted manipulations were administered using a single thrust with an Activator IV instrument on a setting of “2” with the manipulative force delivered to the pedicle-lamina junction of the involved segment in an anterior, superior, and slightly medial line of drive. Furthermore, the manipulations were administered by a practitioner with 29 years of clinical experience in instrument manipulation.

Weaknesses: In this trial, the instrument was used only as a biomechanical device, and no Activator Method analytical protocols were used. The choice of which level of the cervical spine to address was at the discretion of the clinician following static palpation. Also, each type of treatment was delivered by a single clinician, and it is possible that part of the treatment response was due to indirect contextual factors related to participant-provider interaction, rather than the direct effect of the treatment alone.

Bottom Line: The results are not definitive, and further research investigating the differences from previous trials is warranted, but overall I applaud the efforts of my Australian research colleagues.

Dr. Arlan W. Fuhr

Abstract

OBJECTIVE:

The purpose of this study was to compare the effects of 2 different cervical manipulation techniques for mechanical neck pain (MNP).

METHODS:

Participants with MNP of at least 1 month’s duration (n = 65) were randomly allocated to 3 groups: (1) stretching (control), (2) stretching plus manually applied manipulation (MAM), and (3) stretching plus instrument-applied manipulation (IAM). MAM consisted of a single high-velocity, low-amplitude cervical chiropractic manipulation, whereas IAM involved the application of a single cervical manipulation using an (Activator IV) adjusting instrument. Preintervention and postintervention measurements were taken of all outcomes measures. Pain was the primary outcome and was measured using visual analogue scale and pressure pain thresholds. Secondary outcomes included cervical range of motion, hand grip-strength, and wrist blood pressure. Follow-up subjective pain scores were obtained via telephone text message 7 days postintervention.

RESULTS:

Subjective pain scores decreased at 7-day follow-up in the MAM group compared with control (P = .015). Cervical rotation bilaterally (ipsilateral: P = .002; contralateral: P = .015) and lateral flexion on the contralateral side to manipulation (P = .001) increased following MAM. Hand grip-strength on the contralateral side to manipulation (P = .013) increased following IAM. No moderate or severe adverse events were reported. Mild adverse events were reported on 6 occasions (control, 4; MAM, 1; IAM, 1).

CONCLUSION:

This study demonstrates that a single cervical manipulation is capable of producing immediate and short-term benefits for MNP. The study also demonstrates that not all manipulative techniques have the same effect and that the differences may be mediated by neurological or biomechanical factors inherent to each technique.

J Manipulative Physiol Ther. 2016 Jun;39(5):319-29. [PMID: 27180949]

Author information: Gorrell LM, Beath K, Engel RM.  Macquarie University, Sydney, NSW, Australia.

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Attenuation Effect of Spinal Manipulation on Neuropathic and Postoperative Pain Through Activating Endogenous Anti-Inflammatory Cytokine Interleukin 10 in Rat Spinal Cord

January 11, 2016 Activator IV, Animal Models, Inflammation, Research,

Abstract

OBJECTIVES:

The purpose of this study was to investigate roles of the anti-inflammatory cytokine interleukin (IL) 10 and the proinflammatory cytokines IL-1β and tumor necrosis factor α (TNF-α) in spinal manipulation-induced analgesic effects of neuropathic and postoperative pain.

METHODS:

Neuropathic and postoperative pain were mimicked by chronic compression of dorsal root ganglion (DRG) (CCD) and decompression (de-CCD) in adult, male, Sprague-Dawley rats. Behavioral pain after CCD and de-CCD was determined by the increased thermal and mechanical hypersensitivity of the affected hindpaw. Hematoxylin and eosin staining, whole-cell patch clamp electrophysiological recordings, immunohistochemistry, and enzyme-linked immunosorbent assay were used to examine the neural inflammation, neural excitability, and expression of c-Fos and PKC as well as levels of IL-1β, TNF-α, and IL-10 in blood plasma, DRG, or the spinal cord. We used the activator adjusting instrument, a chiropractic spinal manipulative therapy tool, to deliver force to the spinous processes of L5 and L6.

RESULTS:

After CCD and de-CCD treatments, the animals exhibited behavioral and neurochemical signs of neuropathic pain manifested as mechanical allodynia and thermal hyperalgesia, DRG inflammation, DRG neuron hyperexcitability, induction of c-Fos, and the increased expression of PKCγ in the spinal cord as well as increased level of IL-1β and TNF-α in DRG and the spinal cord. Repetitive Activator-assisted spinal manipulative therapy significantly reduced simulated neuropathic and postoperative pain, inhibited or reversed the neurochemical alterations, and increased the anti-inflammatory IL-10 in the spinal cord.

CONCLUSION:

These findings show that spinal manipulation may activate the endogenous anti-inflammatory cytokine IL-10 in the spinal cord and thus has the potential to alleviate neuropathic and postoperative pain.

J Manipulative Physiol Ther. 2016 Jan;39(1):42-53. [PMID:26837229]

Author information: Song XJ, Huang ZJ, Song WB, Song XS, Fuhr AF, Rosner AL, Ndtan H, Rupert R5. Parker University, Parker Research Institute, Dallas, TX.

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Comparing Outcome Measures in Lumbar Spine Manipulations: Dynamic X-Rays and Oswestry Index

January 8, 2016 Activator IV, Clinical Trials, Lumbar Spine, Radiology,

Abstract

Background:

Outcome measurements are used to validate chiropractic adjustments, and they have not always been compared to each other under the same treatment conditions and trials.

Methods:

Twenty-one participants were non-randomly assigned to a treatment or a control group. The Oswestry index questionnaire was completed, and lateral bending lumbar radiographs were collected. Treatment group participants received nine treatments in two weeks, the control group was untreated, and both groups were re-evaluated after two weeks.

Results:

The average number of segments manipulated per day went from 8.3 ± 1.0 (day 1) to 3.0 ± 2.6 (day 9), with a standardized effect size of 2.69. The Oswestry disability index for the treatment group was 29.8% ± 11.8% disability pre-treatment and 14.20% ± 11.5% disability post-treatment, with a standardized effect size of 1.34. In the radiograph analysis, the number of dysfunctional segments changed from 6.8 ± 2.3 pre-treatment to 1.8 ± 5.2 post-treatment, with a standardized effect size of 1.24.

Conclusion:

A significant correlation was found between pre- and post-treatment measurements of the Oswestry index and dynamic radiographs.

Spine Research. 2016 Vol. 2 No. 1: 12 (iMedPub Journals)

Author information: Roy RA, Bouchera JP, Comtois AS. University of Quebec in Montreal, Department of Kinanthropology, Montreal, Quebec, Canada.

ClinicalTrials.gov Identifier: NCT00739570

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A Randomized Controlled Trial to Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate

June 1, 2015 Activator IV, Clinical Trials, Hypertension Blood Pressure, Research,

Abstract

OBJECTIVE:

A randomized controlled trial (RCT) was designed to test effects of specific thoracic (T1 to T5) manipulations using an Activator instrument for changes in diastolic and systolic blood pressure, blood pressure classification, and pulse rates in 290 normotensive and hypertensive people in El Salvador.

METHODS:

Informed consent was obtained from 290 subjects meeting the inclusion criteria. They were randomly assigned to one of three groups: Control (i.e., no treatment, N=95); Placebo treatment (N=96); or Active treatment (N=99). Subjects’ blood pressure and pulse rates were measured after relaxing for 15 minutes, then before intervention, and again just after treatment.

RESULTS:

Systolic and diastolic BP, pulse rate, and BP classification decreased significantly only in the active treatment group. No significant changes occurred in the placebo treatment and control groups. Activator treatment’s effect size in changing hypertension classification as compared to no treatment was a medium d = 0.37, and 0.45 when compared to placebo.

CONCLUSION:

Specific thoracic spinal manipulations affected three measures: blood pressure, pulse rate, and changes in hypertension classification only in the active treatment group. Findings may represent in part a rebound effect from treatment anxiety, but this alone did not account for the observations. Activator instrument’s utility for sham settings was supported for future efficacy studies. The decrease was robust across several analyses, but the duration of the effect requires longer-term follow up.

Asian Journal of Multidisciplinary Studies, Vol 3, No 6, (June, 2015).

Author information: Roffers SD, Menke JM, Morris DH. Chiropractic Research Alliance, 1046 Davis Circle NW, Atlanta, GA 30318, U.S.A.

ClinicalTrials.gov Identifier: NCT01591967

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Neural Response During a Mechanically Assisted Spinal Manipulation in an Animal Model: A Pilot Study

April 6, 2015 Activator IV, Animal Models, Neurophysiological, Research,

Abstract

Introduction:

Mechanoreceptor stimulation is theorized to contribute to the therapeutic efficacy of spinal manipulation. Use of mechanically-assisted spinal manipulation (MA-SM) devices is increasing among manual therapy clinicians worldwide. The purpose of this pilot study is to determine the feasibility of recording in vivo muscle spindle responses during a MA-SM in an intervertebral fixated animal model.

Methods:

Intervertebral fixation was created by inserting facet screws through the left L5-6 and L6-7facet joints of a cat spine. Three L6 muscle spindle afferents with receptive fields in back muscles were isolated. Recordings were made during MA-SM thrusts delivered to the L7 spinous process using an instrumented Activator IV clinical device.

Results:

Nine MA-SM thrusts were delivered with peak forces ranging from 68-122N and with thrust durations of less than 5ms. High frequency muscle spindle discharge occurred during MA-SM. Following the MA-SM, muscle spindle responses included returning to pre-manipulation levels, slightly decreasing for a short window of time, and greatly decreasing for more than 40s.

Conclusion:

This study demonstrates that recording in vivo muscle spindle response using clinical MA-SM devices in an animal model is feasible. Extremely short duration MA-SM thrusts (<5ms) can have an immediate and/or a prolonged (> 40s) effect on muscle spindle discharge. Greater peak forces during MA-SM thrusts may not necessarily yield greater muscle spindle responses. Determining peripheral response during and following spinal manipulation may be an important step in optimizing its’ clinical efficacy. Future studies may investigate the effect of thrust dosage and magnitude.

J Nov Physiother Phys Rehabil 2015 Apr;2(3): 047-054.

Author information: Reed WR, Liebschner MAK, Sozio RS, Pickar JG, Gudavalli MR. Palmer Center for Chiropractic Research, Davenport, IA, USA.

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Comparison of spinal manipulation methods and usual medical care for acute and subacute low back pain: a randomized clinical trial.

February 1, 2015 Activator IV, Clinical Trials, Research,

Abstract

STUDY DESIGN:

Randomized controlled trial with follow-up to 6 months.

OBJECTIVE:

This was a comparative effectiveness trial of manual-thrust manipulation (MTM) versus mechanical-assisted manipulation (MAM); and manipulation versus usual medical care (UMC).

SUMMARY OF BACKGROUND DATA:

Low back pain (LBP) is one of the most common conditions seen in primary care and physical medicine practice. MTM is a common treatment for LBP. Claims that MAM is an effective alternative to MTM have yet to be substantiated. There is also question about the effectiveness of manipulation in acute and subacute LBP compared with UMC.

METHODS:

A total of 107 adults with onset of LBP within the past 12 weeks were randomized to 1 of 3 treatment groups: MTM, MAM, or UMC. Outcome measures included the Oswestry LBP Disability Index (0-100 scale) and numeric pain rating (0-10 scale). Participants in the manipulation groups were treated twice weekly during 4 weeks; subjects in UMC were seen for 3 visits during this time. Outcome measures were captured at baseline, 4 weeks, 3 months, and 6 months.

RESULTS:

Linear regression showed a statistically significant advantage of MTM at 4 weeks compared with MAM (disability = -8.1, P = 0.009; pain = -1.4, P = 0.002) and UMC (disability = -6.5, P = 0.032; pain = -1.7, P < 0.001). Responder analysis, defined as 30% and 50% reductions in Oswestry LBP Disability Index scores revealed a significantly greater proportion of responders at 4 weeks in MTM (76%; 50%) compared with MAM (50%; 16%) and UMC (48%; 39%). Similar between-group results were found for pain: MTM (94%; 76%); MAM (69%; 47%); and UMC (56%; 41%). No statistically significant group differences were found between MAM and UMC, and for any comparison at 3 or 6 months.

Spine (Phila Pa 1976). 2015 Feb 15;40(4):209-17. [PMID:25423308]

Author information: Schneider M, Haas M, Glick R, Stevans J, Landsittel D. School of Health and Rehabilitation Sciences, Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA.

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ClinicalTrials.gov Identifier: NCT01211613

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In Vitro Biomechanical Evaluation of Single Impulse and Repetitive Mechanical Shockwave Devices Utilized for Spinal Manipulative Therapy

December 1, 2014 Activator IV, Activator Methods Chiropractic Technique: General Articles, Activator V, Biomechanical, Neurophysiological, Research, Spine,

Abstract

OBJECTIVE:

The objectives of this study were to determine the ability of several commercial shockwave devices to achieve a desired thrust profile in a benchtop setting, determine the thrust profile in a clinical analog, and determine the influence of operator experience level on device performance.

INTERVENTION AND OUTCOME:

We conducted two different types of testing: (1) bench testing to evaluate the devices themselves, and (2) clinical equivalent testing to determine the influence of the operator.

CONCLUSIONS:

The results indicated a significant dependence of thrust output on the compliance of the test media. The Activator V-E device matched the ideal half-sine thrust profile to 94%, followed by the Impulse device (84%), the Activator IV/FS (74%), and the Activator II (48%). While most devices deviated from the ideal profile on the return path, the Impulse device exhibited a secondary peak. Moreover, the Activator V-E device provided evidence that the device performs consistently despite operator experience level.This has been a major concern in manual spinal manipulation. Based on our results, a hyper-flexible spine would receive a lower peak thrust force than a hypo-flexible spine at the same power setting. Furthermore, a hand-held operation further reduced the peak thrust force as it increased the system compliance. However, that influence was dissimilar for the different devices. Although controlled clinical trials are needed to determine the correlation between thrust profile and clinical outcome, already ongoing clinical studies indicate an improved patient satisfaction due to reduced treatment pain when devices are used with a thrust characteristic closer to an ideal sine wave.

Annals of Biomedical Engineering, Vol. 42, No. 12, December 2014 ( 2014) pp. 2524–2536 DOI: 10.1007/s10439-014-1115-4

Author information: Liebschner, Michael A. K.; Chun, Kwonsoo; Kim, Namhoon; and Ehni, Bruce

Department of Neurosurgery, Baylor College of Medicine, Houston, TX, USA; Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, USA;  Exponent Failure Analysis, Houston, TX, USA;  Department of Pediatrics Cardiology, Baylor College of Medicine, Houston, TX, USA; and Neurosurgery Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, USA

In Vitro Biomechanical Evaluation of Single Impulse and Repetitive

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A pilot study of a chiropractic intervention for management of chronic myofascial temporomandibular disorder.

October 1, 2013 Activator IV, Clinical Trials, Research, Temporomandibular Joint Disorders,

Abstract

BACKGROUND:

Temporomandibular pain has multiple etiologies and a range of therapeutic options. In this pilot study, the authors assessed the feasibility of conducting a larger trial to evaluate chiropractic treatment of temporomandibular disorders (TMDs).

METHODS:

The authors assigned 80 participants randomly into one of the following four groups, all of which included a comprehensive self-care program: reversible interocclusal splint therapy (RIST), Activator Method Chiropractic Technique (AMCT) (Activator Methods International, Phoenix), sham AMCT and self-care only. They made assessments at baseline and at month 2 and month 6, including use of the Research Diagnostic Criteria for Temporomandibular Disorders.

RESULTS:

The authors screened 721 potential participants and enrolled 80 people; 52 participants completed the six-month assessment. The adjusted mean change in current pain over six months, as assessed on the 11-point numerical rating scale, was 2.0 (95 percent confidence interval, 1.1-3.0) for RIST, 1.7 (0.9-2.5) for self-care only, 1.5 (0.7-2.4) for AMCT and 1.6 (0.7-2.5) for sham AMCT. The authors also assessed bothersomeness and functionality.

CONCLUSIONS:

The authors found the study design and methodology to be manageable. They gained substantial knowledge to aid in conducting a larger study. AMCT, RIST and self-care should be evaluated in a future comparative effectiveness study.

PRACTICAL IMPLICATIONS:

This pilot study was a necessary step to prepare for a larger study that will provide clinicians with information that should be helpful when discussing treatment options for patients with TMD.

J Am Dent Assoc. 2013 Oct;144(10):1154-63. [PMID:24080932]

Author information: DeVocht JW, Goertz CM, Hondras MA, Long CR, Schaeffer W, Thomann L, Spector M, Stanford CM. Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, Iowa.

ClinicalTrials.gov Identifier: NCT01021306

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Comparison of paraspinal cutaneous temperature measurements between subjects with and without chronic low back pain.

January 1, 2013 Activator IV, Clinical Trials, Research,

Abstract

OBJECTIVE:

The purpose of this study was to evaluate the effects of chiropractic manipulative treatment on paraspinal cutaneous temperature (PCT) for subjects with chronic low back pain and compare these PCT findings to subjects without chronic low back pain.

METHODS:

Two groups were created, a symptomatic treatment group (subjects with chronic low back pain, n = 11, 7 males, 4 females) and an asymptomatic, nontreatment group (asymptomatic subjects, n = 10, 6 males, 4 females). Outcomes included the modified Oswestry questionnaire and PCT measurements in the prone position after an 8-minute acclimation period. The treatment group received 9 chiropractic spinal instrument-based manipulative treatments over 2 weeks. Reevaluation was done 2 weeks after the initial evaluation for both groups.

RESULTS:

The preintervention Oswestry results (29.8% ± 11.8%) for the treatment group were higher than the asymptomatic group (10.2% ± 10.6%). The postintervention Oswestry results for the treatment group were 14.20 % ± 11.5%. The resulting Cohen’s effect size of the spinal manipulation on the Oswestry evaluation is 0.58. The preintervention PCT showed higher temperature for the nontreatment group compared with the treatment group. Comparing the levels associated with low back pain, the nontreatment group PCT was stable, varying from 0.01°C to 0.02°C, whereas the treatment group PCT varied from 0.10°C to 0.18°C. The treatment group postintervention PCT showed an increase in temperature after the 9 visits; however, this did not reach the values of the asymptomatic group.

CONCLUSION:

The PCT readings for subjects with chronic low back pain were lower than the asymptomatic, nontreatment group. The PCT temperature of the treatment group increased after 9 treatments.

J Manipulative Physiol Ther. 2013 Jan;36(1):44-50. [PMID:23380213]

Author information: Roy RA, Boucher JP, Comtois AS. Department of Kinanthropology, Université du Québec à Montréal, C.P. 8888, Succursale Centre-Ville, Montréal, Québec, Canada.

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