Neck PainMCDNCT01765751
Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial
A study testing Manual Cervical Distraction in people with Neck Pain and Pain in Arm, Unspecified, run by Palmer College of Chiropractic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain, Pain in Arm, Unspecified
- What is being tested?
- Manual Cervical Distraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years (inclusive).
- Mechanical neck pain or neck-related upper extremity pain lasting at least 4 weeks duration.
- Mechanical neck pain or neck-related upper extremity pain classified as Quebec Task Force (QTF) 2-4.
- Naïve to flexion-distraction manual therapy procedures to cervical area.
- Average neck pain in the past 24 hours rated between 3 and 7 on a 0-10 Pain Numerical Rating Scale (NRS) at Phone Screen and Baseline 1 Interview.
- Signed Informed Consent Document.
Who cannot join
- Doctor of chiropractic or current or former chiropractic student.
- Average neck pain in past 24 hours rated 0-2 or 8-10 on a 0-10 Pain NRS at Phone Screen and Baseline 1 Interview.
- Neck pain from other than somatic tissues as determined by history and clinical examination.
- Surgery to cervical-thoracic area within the past 6 months.
- Recent fracture in the cervico-thoracic spine or ribs within the past 8 weeks.
- Injections for pain in neck, shoulders, arms or hands in the past 4 weeks.
Show all 25Show fewer
- Neck pain classified as QTF 1, 5-11.
- Unwillingness to postpone use of all types of manual treatment for neck pain, except those provided in the study for the duration of the study.
- Inability or unwillingness to comply with study protocols.
- Bone or joint pathologies representing a contraindication to study procedures.
- Any single or multisegmental fusion (surgical or congenital) of the 1st through the 7th cervical vertebrae.
- Other safety concerns as determined by the clinical evaluation/opinion at case review.
- Unable to tolerate study procedures.
- Uncontrolled hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
- Simultaneous clinical management for a health condition that compromises ability to deliver study treatment or assess health status.
- Inability to read or verbally comprehend English.
- Drug or alcohol abuse or dependence, suspected or confirmed through self-report questionnaires and clinical interview.
- Depression rated as ≥ 29 on the Beck Depression Inventory.
- Cognitive or memory impairment identified during eligibility exam.
- Pregnancy, under either of the following 2 circumstances: 1) Participant safety, if participant is unable to tolerate or undergo study procedures; or 2) Fetus safety, if x-rays are required for diagnosis.
- Weight greater than 300 lbs (table weight limit).
- Referral for evaluation, diagnosis, or management of other health conditions, or additional diagnostics required for neck pain diagnosis.
- Retention of legal advice or seeking a health-related insurance claim.
- Household member previously enrolled in MCD Clinical Trial.
- Compliance concerns identified during baseline eligibility process.
Trial locations and contacts
1 site in 1 country.
United States1 site
Palmer Center for Chiropractic Research
Davenport, Iowa, 52803
About this study
Official title: Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies
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.
Read the detailed description
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.
- Conditions
- Neck Pain, Pain in Arm, Unspecified
- Being tested
- Manual Cervical Distraction
- Keywords
- Cervical pain, Neck pain, Arm pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Cervical DistractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Manual Cervical Distraction |
| 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. Receives: Procedure: Manual Cervical Distraction |
| 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. Receives: Procedure: Manual Cervical Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, 4, 8, 11, 14 (Each Study Visit)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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:
- A score of 40 is one SD lower than the mean of the reference population (REF POP).
- A score of 60 is one SD higher than the mean of the REF POP.
- For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average REF POP. This could be a desirable or undesirable outcome, depending upon the concept being measured. For Physical Function and Satisfaction with Social Role, higher scores reflect a better outcome, while for the remaining concepts, higher scores reflect a worse outcome.
PROMIS - Pain Interference adjusted for baseline neck pain VAS.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palmer College of Chiropractic
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University
- Responsible party
- Sponsor
- Investigators
- Maruti R. Gudavalli, PhD, Principal investigator, Palmer College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765751
- Sponsor's protocol ID
- U19AT004663
- Acronym
- MCD
- Status last verified
- Jan 2018
- First submitted
- 30 May 2012
- Last updated
- 4 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Once the resulting manuscripts have been published, data sets will be provided for public access. Potential investigators can contact one of the Co-PIs to present their hypothesis, study design, instruments and/or data on which to focus, and resources required. Depending upon the needs and desires of the requesting party, the data that are shared may include analytic tables or de-identified or limited data sets that are transmitted to the requesting parties for additional analyses.
Publications
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.
PubMed 25237767Vining RD, Salsbury SA, Pohlman KA. Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. Trials. 2014 Oct 24;15:406. doi: 10.1186/1745-6215-15-406.
PubMed 25344427Gudavalli 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.
PubMed 24023587Gudavalli 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.
PubMed 25452013Gudavalli 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.
PubMed 26044576Gudavalli 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies
- ClinicalTrials.gov ID
- NCT01765751
- Acronym / sponsor ID
- MCD / U19AT004663
- Conditions
- Neck Pain, Pain in Arm, Unspecified
- Keywords
- Cervical pain, Neck pain, Arm pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Palmer College of ChiropracticUniversity, hospital or other
- Collaborators
- Loyola University
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 4 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Cervical Distraction High Force | Active comparator | Procedure: Manual Cervical DistractionManual 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 | Procedure: Manual Cervical DistractionManual 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 | Procedure: Manual Cervical DistractionManual 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 70 years (inclusive).
- Mechanical neck pain or neck-related upper extremity pain lasting at least 4 weeks duration.
- Mechanical neck pain or neck-related upper extremity pain classified as Quebec Task Force (QTF) 2-4.
- Naïve to flexion-distraction manual therapy procedures to cervical area.
- Average neck pain in the past 24 hours rated between 3 and 7 on a 0-10 Pain Numerical Rating Scale (NRS) at Phone Screen and Baseline 1 Interview.
Key exclusion criteria (25 listed)
- Doctor of chiropractic or current or former chiropractic student.
- Average neck pain in past 24 hours rated 0-2 or 8-10 on a 0-10 Pain NRS at Phone Screen and Baseline 1 Interview.
- Neck pain from other than somatic tissues as determined by history and clinical examination.
- Surgery to cervical-thoracic area within the past 6 months.
- Recent fracture in the cervico-thoracic spine or ribs within the past 8 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Cervical DistractionManual 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. | Procedure or surgery | Manual Cervical Distraction High Force, Manual Cervical Distraction Low Force, Manual Cervical Distraction Medium Force |
Primary outcome
Range of Traction Forces
Time frame: Day 1, 4, 8, 11, 14 (Each Study Visit)
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.
6 secondary outcomes
Neck Disability Index (NDI)
Time frame: Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5)
Neck Pain Visual Analogue Scale (VAS)
Time frame: 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)
Time frame: Change from Baseline to Day 14 (Study Visit 5)
Cervical Range of Motion (cROM).
Time frame: Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5)
Procedure Believability Questionnaire
Time frame: Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5)
Credibility and Expectancy Questionnaire (CEQ)
Time frame: Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25237767Gudavalli 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.
- Background: PubMed 25344427Vining RD, Salsbury SA, Pohlman KA. Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. Trials. 2014 Oct 24;15:406. doi: 10.1186/1745-6215-15-406.
- Background: PubMed 24023587Gudavalli 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.
- Results publication: PubMed 25452013Gudavalli 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.
- Results publication: PubMed 26044576Gudavalli 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.
- Results publicationGudavalli 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.
- Training and certification of doctors of chiropractic in delivering manual cervical traction forces: results of a longitudinal observational study.Link provided by the sponsor.
- Eligibility determination for clinical trials: development of a case review process at a chiropractic research center.Link provided by the sponsor.
- Intradiscal Pressure Changes during Manual Cervical Distraction: A Cadaveric Study.Link provided by the sponsor.
- Clinician proficiency in delivering manual treatment for neck pain within specified force ranges.Link provided by the sponsor.
- Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the resulting manuscripts have been published, data sets will be provided for public access. Potential investigators can contact one of the Co-PIs to present their hypothesis, study design, instruments and/or data on which to focus, and resources required. Depending upon the needs and desires of the requesting party, the data that are shared may include analytic tables or de-identified or limited data sets that are transmitted to the requesting parties for additional analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maruti R. Gudavalli, PhD principal investigator
Palmer College of Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Cervical Distraction in people with Neck Pain and Pain in Arm, Unspecified, run by Palmer College of Chiropractic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Traction Forces (time frame: Day 1, 4, 8, 11, 14 (Each Study Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01765751, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.