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

This study has been completed.
Sponsor:
Collaborator:
Loyola University
Information provided by (Responsible Party):
Palmer College of Chiropractic
ClinicalTrials.gov Identifier:
NCT01765751
First received: May 30, 2012
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Neck Pain
Pain in Arm, Unspecified
Procedure: Manual Cervical Distraction
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies

Resource links provided by NLM:


Further study details as provided by Palmer College of Chiropractic:

Primary Outcome Measures:
  • Range of Traction Forces [ Time Frame: Each Study Visit ] [ Designated as safety issue: Yes ]
    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 will be measured at each study visit (visits 1, 2, 3, 4, 5) for 2 weeks.


Secondary Outcome Measures:
  • Neck Disability Index (NDI) [ Time Frame: Change from Baseline to Study Visit 1 and Study Visit 5 ] [ Designated as safety issue: No ]
    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.

  • Neck Pain Visual Analogue Scale (VAS) [ Time Frame: Change from Baseline, Pre- and Post-Study Visits 1, 2, 3, 4, 5 ] [ Designated as safety issue: Yes ]
    The VAS has excellent metric properties, is easy to administer and score, and is commonly used in pain research. Our anchors will be no pain to worst pain imaginable. We will ask participants to rate their current neck pain at baseline and pre-/post-treatment for all 5 study visits.

  • Patient Reported Outcomes Measurement Information System (PROMIS-43) [ Time Frame: Change from Baseline to Study Visit 5 ] [ Designated as safety issue: Yes ]
    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.

  • Cervical Range of Motion (cROM). [ Time Frame: Change from Study Visit 1 to Study Visit 5 ] [ Designated as safety issue: No ]
    Cervical ranges of motion are a measure of functional status and can be used to assess dysfunction in the cervical spine. CROM will be measured over a two-week time period.

  • Procedure Believability Questionnaire [ Time Frame: Baseline, Study Visit 1, Study Visit 5 ] [ Designated as safety issue: Yes ]
    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 evaluation will be completed based upon treatment description, and compared to assessments following study visit 1 and study visit 5 over a 2-week time period.

  • Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: Baseline, Study Visit 1, Study Visit 5 ] [ Designated as safety issue: No ]
    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.

  • Procedure Believability Qualitative Interview [ Time Frame: Study Visit 5 ] [ Designated as safety issue: Yes ]
    Believability regarding the efficacy and safety of the study treatments will be further assessed through qualitative interviews conducted at the end of Study Visit 5.


Other Outcome Measures:
  • Cervical Muscle Electromyographic (EMG) Activity [ Time Frame: Study Visit 3, Study Visit 4 ] [ Designated as safety issue: No ]
    We will describe electromyographic (EMG) activity of superficial neck muscles during delivery of the three manual interventions. EMG measurements are an exploratory outcome variable in this study.

  • Sociodemographics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline sociodemographic to be collected by patient self-report forms include: age, sex, ethnicity and race, education, occupation, income, and handedness.

  • Medication Use [ Time Frame: Change from Baseline to Study Visit 5 ] [ Designated as safety issue: No ]
    Current non-prescription and prescription medication use will be captured at baseline and at Study Visit 5 by participant self-report.

  • Beck Depression Inventory (BDI) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Depression will be assessed as an eligibility criterion at Baseline using the Beck Depression Inventory, a 21-question multiple-choice self-report instrument.

  • Substance Use Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Alcohol, illicit drugs and tobacco use will be assessed at the Baseline Visit.

  • Vital Signs [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Vital signs, including temperature, pulse, respiration and blood pressure, as well as height and weight (for calculation of Body Mass Index) will be collected at baseline using standard clinical procedures.

  • Neck Pain Numerical Rating Scale (NRS) [ Time Frame: Phone Screen, Baseline ] [ Designated as safety issue: Yes ]
    Neck pain will be rated on an 11-point NRS using the same anchors as the Pain VAS at the telephone screen and baseline to determine eligibility for this study.

  • Chiropractic Beliefs Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participants' beliefs about the chiropractic profession will be assessed with the Chiropractic Beliefs Questionnaire.

  • Patient Satisfaction Questionnaire [ Time Frame: Study Visit 5 ] [ Designated as safety issue: No ]
    Participants' satisfaction with study procedures and staff will be assessed at Study Visit 5 using standard questions.

  • Number of participants with adverse events [ Time Frame: From date of randomization until Study Visit 5 ] [ Designated as safety issue: Yes ]
    Adverse events from study interventions will be assessed for each participant at each Study Visit to assess safety of intervention.


Enrollment: 48
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Manual Cervical Distraction High Force
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.
Procedure: Manual Cervical Distraction
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.
Active Comparator: Manual Cervical Distraction Medium Force
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.
Procedure: Manual Cervical Distraction
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.
Sham Comparator: Manual Cervical Distraction Low Force
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.
Procedure: Manual Cervical Distraction
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765751

Locations
United States, Iowa
Palmer Center for Chiropractic Research
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Palmer College of Chiropractic
Loyola University
Investigators
Principal Investigator: Maruti R. Gudavalli, PhD Palmer College of Chiropractic
  More Information

No publications provided

Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT01765751     History of Changes
Other Study ID Numbers: 5 U19 AT004663-04
Study First Received: May 30, 2012
Last Updated: November 1, 2013
Health Authority: United States: Palmer College of Chiropractic Data and Safety Monitoring Committee

Keywords provided by Palmer College of Chiropractic:
Cervical pain
Neck pain
Arm pain

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014