Clinical trial NCT01765751: Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial
Official title: Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Pain in Arm, Unspecified
Keywords: Cervical pain
Neck pain
Arm pain
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
Collaborators: name: Loyola University
First posted: 2013-01-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Range of Traction Forces
timeFrame: Day 1, 4, 8, 11, 14 (Each Study Visit)
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5)
measure: Neck Pain Visual Analogue Scale (VAS)
timeFrame: Change from Baseline, Day 1, 4, 8, 11, 14 (Pre- and Post-Study Visits 1, 2, 3, 4, 5)
measure: Patient Reported Outcomes Measurement Information System (PROMIS-43)
timeFrame: Change from Baseline to Day 14 (Study Visit 5)
measure: Cervical Range of Motion (cROM).
timeFrame: Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5)
measure: Procedure Believability Questionnaire
timeFrame: Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5)
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5)
Other outcomes:
measure: Cervical Muscle Electromyographic (EMG) Activity
timeFrame: Day 8 (Study Visit 3), Day 11 (Study Visit 4)
measure: Patient Satisfaction Questionnaire
timeFrame: Day 14 (Study Visit 5)
Locations:
city: Davenport
country: United States
facility: Palmer Center for Chiropractic Research
state: Iowa
Study officials:
affiliation: Palmer College of Chiropractic
name: Maruti R. Gudavalli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.