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| Name | Class |
|---|---|
| Loyola University | OTHER |
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The purpose of the Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial is to examine the patient-centered clinical and biomechanical outcomes, doctor treatment delivery, and believability characteristics of a commonly used chiropractic procedure for the treatment of neck- or neck-related arm pain or disability.
The purpose of the Manual Cervical Distraction (MCD): Measuring Chiropractic Delivery for Neck Pain Clinical Trial is to examine the patient-centered clinical and biomechanical outcomes, and believability characteristics of a manually-localized cervical distraction procedure for the treatment of neck- or neck-related arm pain or disability. One challenging issue in the study of manual therapies, including spinal manipulation (SM), is the development of sham and/or minimal intervention procedures suitable for use with control groups in clinical trials. With SM, active treatment requires substantial physical contact between a study clinician and the study participant, either directly or through a mechanical intermediary. Consequently, it is difficult to introduce differences in manual therapy procedures that distinguish sham and/or minimal interventions from the active treatment, but are not immediately obvious to the study participant. Another challenging issue is training clinicians to deliver a standardized SM treatment within specified force ranges. The muscles surrounding the neck could alter the forces transmitted to the cervical spine, and could alter the treatment effectiveness. The purpose of this pilot randomized controlled trial is to examine the patient-centered clinical, biomechanical, and believability outcome characteristics of a manually-localized cervical distraction procedure for the treatment of neck or neck-related arm pain or disability. We also will evaluate the ability of the doctor of chiropractic to deliver the MCD treatment within specified force ranges. An exploratory aim of this study is to evaluate EMG measurement during MCD delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Cervical Distraction High Force | Active Comparator | Manual Cervical Distraction forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
|
| Manual Cervical Distraction Medium Force | Active Comparator | Manual Cervical Distraction forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
|
| Manual Cervical Distraction Low Force | Sham Comparator | Manual Cervical Distraction forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Cervical Distraction | Procedure | Manual Cervical Distraction (MCD) is a form of Low Velocity Variable Amplitude Spinal Manipulation (LVVA-SM). MCD procedure is performed with participant lying prone on a load instrumented table with moveable headpiece allowing guided head movement while recumbent. Clinician gently grasps posterior aspect of participant's neck with a broad contact (contact hand) between thumb and index finger at specific vertebral level. With opposite hand, clinician grasps control handle. Using contact hand, clinician exhibits superior traction to maintain a contact at a single vertebral level and ensuring a gentle movement via contact with control handle. Goal is to create a slow rhythmic (1-3 sec) localized distractive movement. In this trial, only axial distraction (Cox protocol 1) will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Traction Forces | We will evaluate the clinician's ability to deliver three randomly assigned manual interventions to the cervical spine within specified traction force ranges (<20 Newtons [N], 20-50N, >50N). The primary outcome of this study is to determine the accuracy and consistency of traction force delivery ranges both between clinicians and within individual clinicians. Traction force ranges (C5 contact level and Occiput contact level) will be measured at each study visit (visits 1, 2, 3, 4, 5) for 2 weeks and averaged to calculate final outcome. | Day 1, 4, 8, 11, 14 (Each Study Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index (NDI) | The NDI is a 10-item questionnaire modified from the Oswestry Low Back Pain Disability Index. The NDI has been shown to be a reliable and valid measure of disability due to neck pain, and responsive for measuring change. Study Visit 1 and Study Visit 5 Measures occur 2 weeks apart. The NDI scale is measured on a scale of 0-50, with 0 indicating no disability and 50 indicating complete disability. This measure is an adjusted mean NDI change. |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Muscle Electromyographic (EMG) Activity | We will describe electromyographic (EMG) activity of superficial neck muscles during delivery of the three manual interventions during visits 3 and 4. EMG measurements are an exploratory outcome variable in this study. RMS EMG TREATMENT DESCRIPTIONS:
MUSCLES:
ACRONYM KEY:
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Maruti R. Gudavalli, PhD | Palmer College of Chiropractic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palmer Center for Chiropractic Research | Davenport | Iowa | 52803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25237767 | Background | Gudavalli MR, Vining RD, Salsbury SA, Goertz CM. Training and certification of doctors of chiropractic in delivering manual cervical traction forces: Results of a longitudinal observational study. J Chiropr Educ. 2014 Oct;28(2):130-8. doi: 10.7899/JCE-14-18. Epub 2014 Sep 19. | |
| 25344427 | Background | 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. |
| Label | URL |
|---|---|
| Training and certification of doctors of chiropractic in delivering manual cervical traction forces: results of a longitudinal observational study. | View source |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Cervical Distraction Low Force | Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
| FG001 | Manual Cervical Distraction Medium Force | Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
| FG002 | Manual Cervical Distraction High Force | Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Cervical Distraction Low Force | Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Range of Traction Forces | We will evaluate the clinician's ability to deliver three randomly assigned manual interventions to the cervical spine within specified traction force ranges (<20 Newtons [N], 20-50N, >50N). The primary outcome of this study is to determine the accuracy and consistency of traction force delivery ranges both between clinicians and within individual clinicians. Traction force ranges (C5 contact level and Occiput contact level) will be measured at each study visit (visits 1, 2, 3, 4, 5) for 2 weeks and averaged to calculate final outcome. | *Cervical traction forces measured in Newtons (N) over four treatment visits for each participant. We recorded 23 missing values for traction forces due to 9 missing appointments (18 observations) and 5 instances of technical problems in data collection. | Posted | Mean | Standard Deviation | Newtons (N) | Day 1, 4, 8, 11, 14 (Each Study Visit) | Number of Observations* | Number of Observations* |
|
AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures.
*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Cervical Distraction Low Force | Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maruti R. Gudavalli, PhD | Palmer College of Chiropractic | 563-884-5260 | gudavalli_r@palmer.edu |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5) |
| Neck Pain Visual Analogue Scale (VAS) | The VAS has excellent metric properties, is easy to administer and score (0-100mm), and is commonly used in pain research. Our anchors will be no pain (score of 0) to worst pain imaginable (score of 100). We will ask participants to rate their current neck pain at baseline and pre-/post-treatment for all 5 study visits. This measure is adjusted mean neck pain VAS change. A single value was calculated by averaging. | Change from Baseline, Day 1, 4, 8, 11, 14 (Pre- and Post-Study Visits 1, 2, 3, 4, 5) |
| Patient Reported Outcomes Measurement Information System (PROMIS-43) | The PROMIS-43 questionnaire will be used to measure general functional health status. PROMIS-43 questions measure physical function, anxiety, depression, fatigue, sleep disturbance, social role satisfaction, and pain interference and intensity. The table below displays the mean score at baseline. On the T-score metric & interpretation:
PROMIS - Pain Interference adjusted for baseline neck pain VAS. | Change from Baseline to Day 14 (Study Visit 5) |
| Cervical Range of Motion (cROM). | Cervical ranges of motion are a measure of functional status and can be used to assess dysfunction in the cervical spine. Baseline/visit 1 ("BL") cROM is displayed for Flexion-Extension, Lateral Bending, and Rotation. The mean change in cROM from visit 1 to visit 5 ("V5 change") is also displayed. | Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5) |
| Procedure Believability Questionnaire | We will ask all participants whether they feel the study procedure would relieve their neck pain using the Procedure Believability Questionnaire. The response choices will be: "Strongly believe the procedure will relieve my neck pain; Somewhat believe the procedure will relieve my neck pain; Somewhat believe the procedure will NOT relieve my neck pain; Strongly believe the procedure will NOT relieve my neck pain; and Don't know if the procedure will relieve my neck pain". A baseline (BL) evaluation will be completed based upon treatment description, and compared to assessments following study visit 1 (T1) and study visit 5 (T5) over a 2-week time period. | Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5) |
| Credibility and Expectancy Questionnaire (CEQ) | The CEQ is a quick and easy-to-administer questionnaire for measuring treatment expectancy and rationale credibility of interventions for use in clinical outcome studies. Participants' perceptions of the study treatments were compared across groups using the CEQ. The CEQ credibility factor relates to how logical or believable a treatment is for the patient, whereas the expectancy factor refers to the patient's beliefs about improvements that might be achieved from the treatment [61]. CEQ scores for both the credibility and expectancy factors range from 3 to 27, with higher scores indicating greater belief in treatment credibility or expectancy for clinical improvement. | Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5) |
| Day 8 (Study Visit 3), Day 11 (Study Visit 4) |
| Patient Satisfaction Questionnaire | Participants' satisfaction with study procedures and staff were assessed at Study Visit 5 using standard questions. Participants rated their satisfaction with various elements of the study (e.g., treatments received, clinicians) using a 5 category response from 1 (strongly satisfied) to 5 (strongly dissatisfied) with categories collapsed into satisfied (categories 1 and 2) or not satisfied (categories 3, 4 or 5) for interpretation. | Day 14 (Study Visit 5) |
| 24023587 | Background | Gudavalli MR, Potluri T, Carandang G, Havey RM, Voronov LI, Cox JM, Rowell RM, Kruse RA, Joachim GC, Patwardhan AG, Henderson CN, Goertz C. Intradiscal Pressure Changes during Manual Cervical Distraction: A Cadaveric Study. Evid Based Complement Alternat Med. 2013;2013:954134. doi: 10.1155/2013/954134. Epub 2013 Aug 20. |
| 25452013 | Result | Gudavalli MR, Vining RD, Salsbury SA, Corber LG, Long CR, Patwardhan AG, Goertz CM. Clinician proficiency in delivering manual treatment for neck pain within specified force ranges. Spine J. 2015 Apr 1;15(4):570-6. doi: 10.1016/j.spinee.2014.10.016. Epub 2014 Oct 22. |
| 26044576 | Result | Gudavalli MR, Salsbury SA, Vining RD, Long CR, Corber L, Patwardhan AG, Goertz CM. Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain. Trials. 2015 Jun 5;16:259. doi: 10.1186/s13063-015-0770-6. |
| Result | Gudavalli MR, Vining RD, Salsbury SA, Long CR, Patwardhan AG, and Goertz CM. Forces and durations measured during delivery of a manual cervical distraction procedure. Abstract presented at the World Federation of Chiropractic Conference, 2015. |
| Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. | View source |
| Intradiscal Pressure Changes during Manual Cervical Distraction: A Cadaveric Study. | View source |
| Clinician proficiency in delivering manual treatment for neck pain within specified force ranges. | View source |
| Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain. | View source |
| BG001 |
| Manual Cervical Distraction Medium Force |
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
| BG002 | Manual Cervical Distraction High Force | Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
| OG001 | MCD Medium Force | Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
| OG002 | MCD High Force | Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. |
|
|
| Secondary | Neck Disability Index (NDI) | The NDI is a 10-item questionnaire modified from the Oswestry Low Back Pain Disability Index. The NDI has been shown to be a reliable and valid measure of disability due to neck pain, and responsive for measuring change. Study Visit 1 and Study Visit 5 Measures occur 2 weeks apart. The NDI scale is measured on a scale of 0-50, with 0 indicating no disability and 50 indicating complete disability. This measure is an adjusted mean NDI change. | Posted | Mean | 95% Confidence Interval | units on scale | Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5) |
|
|
|
|
| Secondary | Neck Pain Visual Analogue Scale (VAS) | The VAS has excellent metric properties, is easy to administer and score (0-100mm), and is commonly used in pain research. Our anchors will be no pain (score of 0) to worst pain imaginable (score of 100). We will ask participants to rate their current neck pain at baseline and pre-/post-treatment for all 5 study visits. This measure is adjusted mean neck pain VAS change. A single value was calculated by averaging. | Posted | Mean | 95% Confidence Interval | mm | Change from Baseline, Day 1, 4, 8, 11, 14 (Pre- and Post-Study Visits 1, 2, 3, 4, 5) |
|
|
|
|
| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS-43) | The PROMIS-43 questionnaire will be used to measure general functional health status. PROMIS-43 questions measure physical function, anxiety, depression, fatigue, sleep disturbance, social role satisfaction, and pain interference and intensity. The table below displays the mean score at baseline. On the T-score metric & interpretation:
PROMIS - Pain Interference adjusted for baseline neck pain VAS. | Posted | Mean | Standard Deviation | T-score | Change from Baseline to Day 14 (Study Visit 5) |
|
|
|
|
| Secondary | Cervical Range of Motion (cROM). | Cervical ranges of motion are a measure of functional status and can be used to assess dysfunction in the cervical spine. Baseline/visit 1 ("BL") cROM is displayed for Flexion-Extension, Lateral Bending, and Rotation. The mean change in cROM from visit 1 to visit 5 ("V5 change") is also displayed. | The number analyzed in row differs from overall due to:
| Posted | Mean | Standard Deviation | Degrees - Range of Motion | Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5) |
|
|
|
| Secondary | Procedure Believability Questionnaire | We will ask all participants whether they feel the study procedure would relieve their neck pain using the Procedure Believability Questionnaire. The response choices will be: "Strongly believe the procedure will relieve my neck pain; Somewhat believe the procedure will relieve my neck pain; Somewhat believe the procedure will NOT relieve my neck pain; Strongly believe the procedure will NOT relieve my neck pain; and Don't know if the procedure will relieve my neck pain". A baseline (BL) evaluation will be completed based upon treatment description, and compared to assessments following study visit 1 (T1) and study visit 5 (T5) over a 2-week time period. | Posted | Count of Participants | Participants | Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5) |
|
|
|
| Secondary | Credibility and Expectancy Questionnaire (CEQ) | The CEQ is a quick and easy-to-administer questionnaire for measuring treatment expectancy and rationale credibility of interventions for use in clinical outcome studies. Participants' perceptions of the study treatments were compared across groups using the CEQ. The CEQ credibility factor relates to how logical or believable a treatment is for the patient, whereas the expectancy factor refers to the patient's beliefs about improvements that might be achieved from the treatment [61]. CEQ scores for both the credibility and expectancy factors range from 3 to 27, with higher scores indicating greater belief in treatment credibility or expectancy for clinical improvement. | Posted | Mean | Standard Deviation | units on a scale (range 3-27) | Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5) |
|
|
|
| Other Pre-specified | Cervical Muscle Electromyographic (EMG) Activity | We will describe electromyographic (EMG) activity of superficial neck muscles during delivery of the three manual interventions during visits 3 and 4. EMG measurements are an exploratory outcome variable in this study. RMS EMG TREATMENT DESCRIPTIONS:
MUSCLES:
ACRONYM KEY:
| The numbers analyzed in the row differ from the overall due to: (1) Data not collected due to technical problems, (2) Patient did not show up for the visit, (3) 3 participants lost to follow up. | Posted | Mean | Standard Deviation | ratio | Day 8 (Study Visit 3), Day 11 (Study Visit 4) |
|
|
|
| Other Pre-specified | Patient Satisfaction Questionnaire | Participants' satisfaction with study procedures and staff were assessed at Study Visit 5 using standard questions. Participants rated their satisfaction with various elements of the study (e.g., treatments received, clinicians) using a 5 category response from 1 (strongly satisfied) to 5 (strongly dissatisfied) with categories collapsed into satisfied (categories 1 and 2) or not satisfied (categories 3, 4 or 5) for interpretation. | Posted | Count of Participants | Participants | Day 14 (Study Visit 5) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 6 |
| 16 |
| EG001 | Manual Cervical Distraction Medium Force* | Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. | 0 | 16 | 0 | 16 | 10 | 16 |
| EG002 | Manual Cervical Distraction High Force* | Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput. | 0 | 16 | 0 | 16 | 10 | 16 |
| Thoracic Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Low Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck and back pain/stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tenderness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| General soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache and neck/back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain and extremity pain/stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck, back and extremity pain/stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain/stiffness and headache and dizziness/vertigo | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain/stiffness and chest soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizzinesss/imbalance/vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | Systematic Assessment |
|
| Thyroid disregulation | Endocrine disorders | Systematic Assessment |
|
| Increased intraocular pressure | Eye disorders | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lower respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper respiratory infection and joint pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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|
| Mean Difference (Final Values) |
| 3.0 |
| 2-Sided |
| 95 |
| 0.1 |
| 5.9 |
Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method. |
| Superiority |
| Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -3.2 | 2.7 | High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method. | Superiority |
| Mean Difference (Final Values) |
| 9.8 |
| 2-Sided |
| 95 |
| -3.7 |
| 23.3 |
Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method. |
| Superiority |
| Mean Difference (Final Values) | 5.8 | 2-Sided | 95 | -8.6 | 20.3 | High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method. | Superiority |
|
| PROMIS - Physical Function (baseline) |
|
| PROMIS - Physical Function (Day 14) |
|
| PROMIS - Fatigue (baseline) |
|
| PROMIS - Fatigue (Day 14) |
|
| PROMIS - Sleep Disturbance (baseline) |
|
| PROMIS - Sleep Disturbance (Day 14) |
|
| PROMIS - Anxiety (baseline) |
|
| PROMIS - Anxiety (Day 14) |
|
| PROMIS - Depression (baseline) |
|
| PROMIS - Depression (Day 14) |
|
| PROMIS - Satisfaction with Social Role (baseline) |
|
| PROMIS - Satisfaction with Social Role (Day 14) |
|
Pain Interference |
| Mean Difference (Net) |
| 1.5 |
| 2-Sided |
| 95 |
| -2.6 |
| 5.6 |
Pain Interference - Medium vs Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. |
| Superiority |
| Pain Interference | Mean Difference (Net) | -5.4 | 2-Sided | 95 | -9.8 | 1.0 | Pain Interference - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Physical Function | Mean Difference (Net) | 0.8 | 2-Sided | 95 | -2.2 | 3.8 | Physical Function - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Physical Funtion | Mean Difference (Net) | 0.1 | 2-Sided | 95 | -2.9 | 3.2 | Physical Function - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Physical Function | Mean Difference (Net) | 0.7 | 2-Sided | 95 | -2.4 | 3.7 | Physical Function- High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population | Superiority |
| Fatigue | Mean Difference (Net) | 5.8 | 2-Sided | 95 | 1.1 | 10.5 | Fatigue - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Fatigue | Median Difference (Net) | 3.3 | 2-Sided | 95 | -1.5 | 8.2 | Fatigue - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Fatigue | Mean Difference (Net) | 2.5 | 2-Sided | 95 | -2.3 | 7.3 | Fatigue - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Sleep Disturbance | Mean Difference (Net) | 1.3 | 2-Sided | 95 | -0.9 | 3.5 | Sleep Disturbance - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Sleep Disturbance | Mean Difference (Net) | -1.4 | 2-Sided | 95 | -3.6 | 0.9 | Sleep Disturbance - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Sleep Disturbance | Mean Difference (Net) | 2.7 | 2-Sided | 95 | 0.4 | 5.0 | Sleep Disturbance - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Anxiety | Mean Difference (Net) | -0.3 | 2-Sided | 95 | -4.5 | 3.9 | Anxiety - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Anxiety | Mean Difference (Net) | 1.1 | 2-Sided | 95 | -2.9 | 5.1 | Anxiety - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Anxiety | Mean Difference (Net) | -1.4 | 2-Sided | 95 | -5.7 | 2.9 | Anxiety - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Depression | Mean Difference (Net) | -2.8 | 2-Sided | 95 | -6.7 | 0.6 | Depression - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Depression | Mean Difference (Net) | -0.8 | 2-Sided | 95 | -4.1 | 2.6 | Depression - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Depression | Mean Difference (Net) | -2.0 | 2-Sided | 95 | -5.4 | 1.4 | Depression - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Satisfaction with Social Role | Mean Difference (Net) | 0.2 | 2-Sided | 95 | -4.5 | 4.9 | Satisfaction with Social Role - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Satisfaction with Social Role | Mean Difference (Net) | 3.0 | 2-Sided | 95 | -1.8 | 7.7 | Satisfaction with Social Role - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| Satisfaction with Social Role | Mean Difference (Net) | -2.8 | 2-Sided | 95 | -7.6 | 2.0 | Satisfaction with Social Role - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | Superiority |
| BL - Mean Lateral Bending |
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| BL - Mean Rotation |
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| Mean Change from BL to V5 - Flexion-Extension |
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| Mean Change from BL to V5 - Lateral Bending |
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| Mean Change from BL to V5 - Rotation |
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| Title | Measurements |
|---|---|
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| BL - Somewhat will not |
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| BL - Strongly will NOT |
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| BL - Don't know |
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| T1 - Strongly WILL |
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| T1 - Somewhat WILL |
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| T1 - Somewhat will not |
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| T1 - Strongly will NOT |
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| T1 - Don't know |
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| T5 - Strongly WILL |
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| T5 - Somewhat WILL |
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| T5 - Somewhat will not |
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| T5 - Strongly will NOT |
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| T5 - Don't know |
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| T5 - Missing |
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| Credibility Factor - Study Visit 5 |
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| Expectancy Factor - Baseline Visit 1 |
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| Expectancy Factor - Study Visit 1 |
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| Expectancy Factor - Study Visit 5 |
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| Visit 3 - (A) - RES |
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| Visit 3 - (A) - LTRPS |
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| Visit 3 - (A) - RTRPS |
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| Visit 3 - (A) - LSCM |
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| Visit 3 - (A) - RSCM |
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| Visit 3 - (B) - LES |
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| Visit 3 - (B) - RES |
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| Visit 3 - (B) - LTRPS |
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| Visit 3 - (B) - RTRPS |
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| Visit 3 - (B) - LSCM |
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| Visit 3 - (B) - RSCM |
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| Visit 3 - (C) - LES |
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| Visit 3 - (C) - RES |
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| Visit 3 - (C) - LTRPS |
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| Visit 3 - (C) - RTRPS |
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| Visit 3 - (C) - LSCM |
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| Visit 3 - (C) - RSCM |
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| Visit 3 - (D) - LES |
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| Visit 3 - (D) - RES |
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| Visit 3 - (D) - LTRPS |
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| Visit 3 - (D) - RTRPS |
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| Visit 3 - (D) - LSCM |
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| Visit 3 - (D) - RSCM |
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| Visit 4 - (A) - LES |
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| Visit 4 - (A) - RES |
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| Visit 4 - (A) - LTRPS |
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| Visit 4 - (A) - RTRPS |
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| Visit 4 - (A) - LSCM |
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| Visit 4 - (A) - RSCM |
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| Visit 4 - (B) - LES |
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| Visit 4 - (B) - RES |
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| Visit 4 - (B) - LTRPS |
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| Visit 4 - (B) - RTRPS |
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| Visit 4 - (B) - LSCM |
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| Visit 4 - (B) - RSCM |
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| Visit 4 - (C) - LES |
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| Visit 4 - (C) - RES |
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| Visit 4 - (C) - LTRPS |
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| Visit 4 - (C) - RTRPS |
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| Visit 4 - (C) - LSCM |
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| Visit 4 - (C) - RSCM |
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| Visit 4 - (D) - LES |
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| Visit 4 - (D) - RES |
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| Visit 4 - (D) - LTRPS |
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| Visit 4 - (D) - RTRPS |
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| Visit 4 - (D) - LSCM |
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| Visit 4 - (D) - RSCM |
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