Archive for category Clinical Trials

A Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial Assessing the Effects of Applying a Force to C5 by a Mechanically Assisted Instrument (MAI) on Referred Pain to the Shoulder

April 1, 2018 Clinical Trials, Research,

Abstract

Objective:

To determine the effects of applying a force to C5 of the spine by a mechanically assisted instrument (MAI) in patients with referred shoulder pain.

Summary of Background Data:

Manipulating C5 of the spine is a chiropractic treatment for referred shoulder pain, there are no clinical trials evaluating its efficacy. Outcome measures were patient ranked questionnaires and independent examiner findings. One hundred and twenty-five patients were diagnosed with referred shoulder pain of cervical origin; sixty-five were in the treatment cohort and sixty in the placebo cohort.

Methods:

This was a prospective, randomized, double-blind, placebo-controlled trial assessing the effects of applying a force to C5 by an MAI to patients with referred shoulder pain. The treatment cohort had the MAI set at the maximum setting to transmit a force into the spine; the placebo cohort had the MAI turned off. Primary outcome measures were frequency and severity of extreme shoulder pain obtained via a patient-reported questionnaire; secondary outcome measures were patient ranked pain and functional outcomes, as well as the examiner, assessed the range of motion and strength. Assessment procedures were completed at 24 weeks post-treatment and data were analyzed with intent to treat protocol.

Results:

There was a reduction in the frequency but not the severity of extreme shoulder pain in the treatment cohort, average ranking reducing from weekly to monthly (p < 0.05). Patients treated with the MAI had 10 N (p = 0.04) better internal rotation strength after 6 months post-treatment. No differences with any other outcome measures between the two cohorts at the 24 week study period.

Conclusion:

The major effect of applying an MAI to the level of C5 of the spine in referred shoulder pain is improved shoulder strength for internal rotation in this randomized double-blinded clinical trial.

Spine (Phila Pa 1976). 2017 Sep 6.  PMID: 28885296
Author information: Hardas GM, Murrell GA. Orthopaedic Research Institute, St George Hospital Clinical School, Faculty of Medicine, UNSW, Sydney, Australia.

Epub ahead of print

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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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Clinical Trials

April 15, 2016 Clinical Trials, Research,

Published Clinical Trials Using the Activator Adjusting Instrument (AAI)

The Activator Method is one of the most widely researched chiropractic techniques and the only instrument adjusting technique with clinical trials to support its efficacy. The following list of clinical trials demonstrate that there is sufficient published evidence that use of the Activator adjusting instrument results in therapeutic benefits equivalent to manual-thrust and/or diversified chiropractic manipulation.

  1. Effects of chiropractic treatment on blood pressure and anxiety: a randomized, controlled trial. Yates RG, Lamping DL, Abram NL, Wright C. J Manipulative Physiol Ther. 1988 Dec;11(6):484-8.

Main Results/Conclusions: Systolic and diastolic blood pressure decreased significantly in the active treatment condition. No significant changes occurred in the placebo and control conditions. Anxiety significantly decreased in the active and control conditions.

  1. Treatment and biomechanical assessment of patients with chronic sacroiliac joint syndrome. Osterbauer PJ, De Boer KF, Widmaier R, Petermann E, Fuhr AW. J Manipulative Physiol Ther. 1993 Feb;16(2):82-90.

Main Results/Conclusions: Activator proved beneficial in treatment of chronic Sacro-Iliac Joint Syndrome (SIJS); average Oswestry Disability Index (ODI) scores diminished from 28 to 13%.

  1. The immediate effect of activator vs. meric adjustment on acute low back pain: a randomized controlled trial. Gemmell HA, Jacobson BH. J Manipulative Physiol Ther. 1995 Sep;18(7):453-6.

Main Results/Conclusions: Both interventions showed improvement in all outcome measures, but no statistical significance between groups.

  1. Comparison of two chiropractic techniques on pain and lateral flexion in neck pain patients: a pilot study. Yurkiw D, Mior S. Chiropractic Technique. 1996 Nov;8(4):155-162.

Main Results/Conclusions: No statistical significance between interventions. Both interventions showed immediate improvement in all outcome measures.

  1. The effects of spinal manipulation on the intensity of emotional arousal in phobic subjects exposed to a threat stimulus: a randomized, controlled, double-blind clinical trial. Peterson KB. J Manipulative Physiol Ther. 1997 Nov-Dec;20(9):602-6.

Main Results/Conclusions: Activator-assisted spinal manipulation significantly decreased the intensity of emotional arousal reported by phobic subjects.

  1. A pilot randomized clinical trial on the relative effect of instrumental (MFMA) versus manual (HVLA) manipulation in the treatment of cervical spine dysfunction. Wood TG, Colloca CJ, Matthews R. J Manipulative Physiol Ther. 2001 May;24(4):260-71.

Main Results/Conclusions: No statistical significance between interventions. Both Activator and manual manipulation showed beneficial effects in reducing pain and disability while increasing range of motion.

  1. Chiropractic treatment of temporomandibular disorders using the activator adjusting instrument: a prospective case series. DeVocht JW, Long CR, Zeitler DL, Schaeffer W. J Manipulative Physiol Ther. 2003 Sep;26(7):421-5.

Main Results/Conclusions: Signs and symptoms of temporomandibular disorders improved with the course of Activator Methods treatment.

  1. A randomized clinical trial of manual versus mechanical force manipulation in the treatment of sacroiliac joint syndrome. Shearar KA, Colloca CJ, White HL. J Manipulative Physiol Ther. 2005 Sep;28(7):493-501.

Main Results/Conclusions: No statistical significance between interventions. Both interventions showed immediate improvement in all outcome measures.

  1. Immediate effect of activator trigger point therapy and myofascial band therapy on non-specific neck pain in patients with upper trapezius trigger points compared to sham ultrasound: A randomised controlled trial. Blikstad A, Gemmell H. Clinical Chiropractic (2008) 11, 23—29.

Main Results/Conclusions: Activator trigger point therapy appeared to be more effective than myofascial band therapy or sham ultrasound in treating patients with non-specific neck pain and upper trapezius trigger points.

  1. Relative immediate effect of ischaemic compression and activator trigger point therapy on active upper trapezius trigger points: A randomised trial. Gemmell H, Allen A. Clinical Chiropractic (2008) 11,175—181.

Main Results/Conclusions: Both interventions showed improvement in all outcome measures, but no statistical significance between groups

  1. Effects of a manually assisted mechanical force on cutaneous temperature. Roy RA, Boucher JP, Comtois AS. J Manipulative Physiol Ther. 2008 Mar;31(3):230-6.

Main Results/Conclusions: Before treatment, the cutaneous temperature (CT) was significantly different between the ipsilateral and the contralateral sides for all subgroups consistent with a positive L4/L5 isolation test. At 10 minutes after intervention, CT increased significantly for the treatment group but not for the sham and control groups. Furthermore, after manipulation using the Activator with a thrust respecting the standard loading principle of the instrument, it produced a secondary cooling at 5 minutes followed by a rewarming at 10 minutes consistent with a neurophysiological response.

  1. Heart rate variability modulation after manipulation in pain-free patients vs patients in pain. Roy RA, Boucher JP, Comtois AS. J Manipulative Physiol Ther. 2009 May;32(4):277-86.

Main Results/Conclusions: No statistical significance between interventions except for control group. Both interventions showed similar modulation of the HRV.

  1. Relative effectiveness and adverse effects of cervical manipulation, mobilisation and the activator instrument in patients with sub-acute non-specific neck pain: results from a stopped randomised trial. Gemmell H, Miller P. Chiropr Osteopat. 2010 Jul 9;18:20.

Main Results/Conclusions: There were no significant differences between the groups at any of the follow up points. All groups exhibited long-term improvement without one being superior to the other.

  1. Mechanical vs manual manipulation for low back pain: an observational cohort study. Schneider MJ, Brach J, Irrgang JJ, Abbott KV, Wisniewski SR, Delitto A. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):193-200.

Main Results/Conclusions: This study found neither intervention superior to the other, while providing the chiropractic profession with valuable information on the influence of treatment expectation.

  1. Inflammatory response following a short-term course of chiropractic treatment in subjects with and without chronic low back pain. Roy RA, Boucher JP, Comtois AS. J Chiropr Med. 2010 Sep;9(3):107-14.

Main Results/Conclusions: A total of 9 chiropractic lower back manipulations with the Activator caused the mediators of inflammation to present a normalization response in individuals suffering from chronic low back pain.

  1. Changes in Pressure Pain Thresholds and Basal Electromyographic Activity After Instrument-Assisted Spinal Manipulative Therapy in Asymptomatic Participants: A Randomized, Controlled Trial. Yu X, Wang X, Zhang J, Wang Y. J Manipulative Physiol Ther. 2012 Jul;35(6):437-45.

Main Results/Conclusions: The application of Activator instrument resulted in an immediate and widespread hypoalgesic effect with local muscle relaxation in asymptomatic participants.

  1. Comparison of paraspinal cutaneous temperature measurements between subjects with and without chronic low back pain. Roy RA, Boucher JP, Comtois AS. J Manipulative Physiol Ther. 2013 Jan;36(1):44-50.

Main Results/Conclusions: The Paraspinal Cutaneous Temperature (PCT) readings for subjects with chronic low back pain were lower than the asymptomatic, nontreatment group. The PCT temperature of the treatment group normalized after nine (9) treatments.

  1. A pilot study of a chiropractic intervention for management of chronic myofacial TMD. DeVocht JW, Goertz CM, Hondras MA, Long CR, Schaeffer W, Thomann L, Spector M, Stanford CM. J Am Dent Assoc. 2013 Oct;144(10).

Main Results/Conclusions: 721 potential participants were screened, 80 enrolled, and 53 completed the 6 month assessment. In the end, the logistics were found to be manageable. NOTE: This pilot study was funded by a NCCAM TMD study grant (2008) and was a necessary step in preparation for a larger Randomized Control Trial that will provide clinicians with information helpful when discussing treatment options for those who suffer with TMD.

  1. Comparison of Spinal Manipulation Methods and Usual Medical Care for Acute and Subacute Low Back Pain: A Randomized Clinical Trial. Schneider M, Haas M, Glick R, Stevans J, Landsittel D. Spine 2015;40:209-217.

Main Results/Conclusions: This study found that manual-thrust manipulation (MTM) provided slightly greater short-term (at 4 weeks) reductions in self-reported disability and pain scores compared with mechanical-assisted manipulation (Activator) or usual medical care (UMC); Activator was more effective for pain reduction than usual medical care in the first two-weeks. In addition, the benefit of MTM seen at end-of-intervention was no longer statistically significant at 3 or 6 months. All interventions seem similar in effect; they lead to decreased pain and disability.

  1. A Randomized Controlled Trial to Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate. Roffers SD, Menke JM, Morris DH. Asian Journal of Multidisciplinary Studies, Volume 3, Issue 6, June 2015.

Main Results/Conclusions: Specific thoracic spinal manipulations affected three measures: blood pressure, pulse rate, and changes in hypertension classification only in the active treatment group. Activator instrument’s utility for sham settings was supported for future efficacy studies.

  1. Comparing Outcome Measures in Lumbar Spine Manipulations: Dynamic X-Rays and Oswestry Index.Roy RA, Bouchera JP, Comtois AS. Spine Research, Spine Research. 2016 Vol. 2 No. 1: 12 (iMedPub Journal)

Main Results/Conclusions: Dynamic radiographs and the Oswestry index appear to be sensitive enough to detect a strong effect size after a 9-treatment course of therapy. In addition, a significant correlation was found between pre- and post-treatment measurements of the Oswestry index and dynamic radiographs which could help validate the necessity of continued care.

  1. Manual and Instrument Applied Cervical Manipulation for Mechanical Neck Pain: A Randomized Controlled Trial. Gorrell LM, Beath K, Engel RM. J Manipulative Physiol Ther. 2016 Jun;39(5):319-29.

Main Results/Conclusions: This study demonstrates that a single cervical manipulation is capable of producing both immediate and short-term benefits for mechanical neck pain. The study also may demonstrate that not all manipulative techniques have the same effect. The results reported in this study are consistent with the hypothesis that the biomechanical characteristics of different spinal manipulation techniques may be responsible for varying clinical effects. However, the results are not definitive, and further research investigating the nature of these changes is warranted.

  1. A Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial Assessing the Effects of Applying a Force to C5 by a Mechanically Assisted Instrument (MAI) on Referred Pain to the Shoulder.  Hardas GM, Murrell GA. Spine (Phila Pa 1976). 2017 Sep 6.

Main Results/Conclusions: The major effect of applying an MAI to the level of C5 of the spine in referred shoulder pain is improved shoulder strength for internal rotation in this randomized double-blinded clinical trial.

Systematic Review

The following systematic review of the literature demonstrates that there is sufficient published evidence that use of the Activator adjusting instrument results in therapeutic benefits equivalent to manual-thrust and/or diversified chiropractic manipulation.

Clinical effectiveness of the activator adjusting instrument in the management of musculo-skeletal disorders: a systematic review of the literature. Huggins T, Boras AL, Gleberzon BJ, Popescu M, Bahry LA. J Can Chiropr Assoc. 2012 Mar;56(1):49-57.

Main Results/Conclusions: “This systematic review of 8 clinical trials involving the use of the AAI (Activator) found reported benefits to patients with spinal pain and trigger points, although these results were not statistically significantly different when compared to the use of HVLA manual manipulation or trigger point therapy.”

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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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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.

Full Text Article

ClinicalTrials.gov Identifier: NCT01211613

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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

Free PMC Article

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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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Changes in pressure pain thresholds and Basal electromyographic activity after instrument-assisted spinal manipulative therapy in asymptomatic participants: a randomized, controlled trial.

July 1, 2012 Activator IV, Clinical Trials, Neurophysiological, Research,

Abstract

OBJECTIVE:

The purpose of this study was to investigate the effects of instrument-assisted spinal manipulative therapy (SMT) targeted to the low-back region on changes in pressure pain thresholds (PPTs) and basal electromyographic activity (BEA) in asymptomatic participants.

METHODS:

A repeated-measures, single-blind, randomized trial was conducted on 30 participants, 19 men and 11 women (mean age, 24.5±3.9 years), without a current history of low-back pain. Each participant attended all 2 treatment group sessions and received instrument-assisted SMT or a sham manipulation procedure. Instrument-assisted SMT was administered using the Activator Method protocol. Bilateral PPT levels over L5-S1 zygapophyseal joints, L5 dermatome, and first dorsal interossei in the hand and bilateral BEA of low back and neck region were assessed pre- and posttreatment by an assessor blinded to the treatment allocation of the participant. A 3-way analysis of variance with time (pre-post) and side (ipslateral, contralateral to the intervention) as within-group variable and intervention (manipulation or sham) as between-group variable was used to evaluate changes in PPT. A paired sample t test was used to analyze the differences between pre- and posttreatment in BEA.

RESULTS:

The group vs time interaction was statistically significant for PPT irrespective of the site tested or the side treated. Participants receiving the instrument-assisted SMT experienced greater improvement in PPT when compared with the control group. Paired sample t tests for BEA only show an immediate decrease in BEA of the paraspinal muscle on the pelvic deficiency side of the low-back region.

CONCLUSIONS:

The application of instrument-assisted SMT resulted in an immediate and widespread hypoalgesic effect with local muscle relaxation in asymptomatic participants. It is hypothesized that therapeutic mechanisms, either segmental or central, may be involved in the therapeutic effects of instrument-assisted SMT.

J Manipulative Physiol Ther. 2012 Jul;35(6):437-45. [PMID:22902139]

Author information: Yu X, Wang X, Zhang J, Wang Y. Department of Physical Medicine and Rehabilitation, Renji Hospital, Jiaotong University, School of Medicine, Shanghai, China.

ClinicalTrials.gov Identifier: NCT01469533

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