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Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial (MCD)

Primary Purpose

Neck Pain, Pain in Arm, Unspecified

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Manual Cervical Distraction

About this trial

This is an interventional supportive care trial for Neck Pain focused on measuring Cervical pain, Neck pain, Arm pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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.

Exclusion Criteria

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.
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.

Sites / Locations

Palmer Center for Chiropractic Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

Manual Cervical Distraction High Force

Manual Cervical Distraction Medium Force

Manual Cervical Distraction Low Force

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01765751

First Posted

May 30, 2012

Last Updated

January 3, 2018

Sponsor

Palmer College of Chiropractic

Collaborators

Loyola University

1. Study Identification

Unique Protocol Identification Number

NCT01765751

Brief Title

Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial

Acronym

MCD

Official Title

Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Palmer College of Chiropractic

Collaborators

Loyola University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain, Pain in Arm, Unspecified

Keywords

Cervical pain, Neck pain, Arm pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Manual Cervical Distraction High Force

Arm Type

Active Comparator

Arm Description

Arm Title

Manual Cervical Distraction Medium Force

Arm Type

Active Comparator

Arm Description

Arm Title

Manual Cervical Distraction Low Force

Arm Type

Sham Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Manual Cervical Distraction

Intervention Description

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.

Primary Outcome Measure Information:

Title

Range of Traction Forces

Description

Time Frame

Day 1, 4, 8, 11, 14 (Each Study Visit)

Secondary Outcome Measure Information:

Title

Neck Disability Index (NDI)

Description

Time Frame

Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5)

Title

Neck Pain Visual Analogue Scale (VAS)

Description

Time Frame

Change from Baseline, Day 1, 4, 8, 11, 14 (Pre- and Post-Study Visits 1, 2, 3, 4, 5)

Title

Patient Reported Outcomes Measurement Information System (PROMIS-43)

Description

Time Frame

Change from Baseline to Day 14 (Study Visit 5)

Title

Cervical Range of Motion (cROM).

Description

Time Frame

Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5)

Title

Procedure Believability Questionnaire

Description

Time Frame

Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5)

Title

Credibility and Expectancy Questionnaire (CEQ)

Description

Time Frame

Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5)

Other Pre-specified Outcome Measures:

Title

Cervical Muscle Electromyographic (EMG) Activity

Description

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: (A) Ratio of Root Mean square (RMS) EMG during Treatment at C5/RMS EMG during maximum voluntary contraction (MVC) (B) RMS EMG during Treatment at C5/RMS EMG during Prone Resting (C) RMS EMG during Treatment at Occiput (OCC)/RMS EMG during MVC (D) RMS EMG during Treatment at OCC/ RMS EMG during Prone Resting MUSCLES: LES-Left erector Spinae Muscle RES-Right Erector Spinae Muscle LTRPS- Left Trapezius muscle RTRPS- Right Trapezius Muscle LSCM- Left Sternocleido Mastoid muscle RSCM- Right Sternocleido Mastoid Muscle ACRONYM KEY: RMS-Root Mean Square Value MVC-Maximum Voluntary Contraction C5-Cervical vertebrae contact OCC-Occipital contact EMG-Electromyographic activity

Time Frame

Day 8 (Study Visit 3), Day 11 (Study Visit 4)

Title

Patient Satisfaction Questionnaire

Description

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.

Time Frame

Day 14 (Study Visit 5)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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. Exclusion Criteria 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maruti R. Gudavalli, PhD

Organizational Affiliation

Palmer College of Chiropractic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Palmer Center for Chiropractic Research

City

Davenport

State/Province

Iowa

ZIP/Postal Code

52803

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Once the resulting manuscripts have been published, data sets will be provided for public access. Potential investigators can contact one of the Co-PIs to present their hypothesis, study design, instruments and/or data on which to focus, and resources required. Depending upon the needs and desires of the requesting party, the data that are shared may include analytic tables or de-identified or limited data sets that are transmitted to the requesting parties for additional analyses.

Citations:

PubMed Identifier

25237767

Citation

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.

Results Reference

background

PubMed Identifier

25344427

Citation

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.

Results Reference

background

PubMed Identifier

24023587

Citation

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.

Results Reference

background

PubMed Identifier

25452013

Citation

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.

Results Reference

result

PubMed Identifier

26044576

Citation

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.

Results Reference

result

Citation

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.

Results Reference

result

Links:

URL

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4211585/

Description

Training and certification of doctors of chiropractic in delivering manual cervical traction forces: results of a longitudinal observational study.

URL

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221721/

Description

Eligibility determination for clinical trials: development of a case review process at a chiropractic research center.

URL

https://www.ncbi.nlm.nih.gov/pubmed/24023587

Description

Intradiscal Pressure Changes during Manual Cervical Distraction: A Cadaveric Study.

URL

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4375060/

Description

Clinician proficiency in delivering manual treatment for neck pain within specified force ranges.

URL

https://www.ncbi.nlm.nih.gov/pubmed/26044576

Description

Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

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Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial

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