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

NCT01765751 | Completed Results DMC

• 1 other identifier: U19AT004663
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Pain in Arm, Unspecified

Keywords

Cervical pain; Neck pain; Arm pain

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Neck Disability Index (NDI)

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

• Neck Pain Visual Analogue Scale (VAS)

  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)

  Change from Baseline to Day 14 (Study Visit 5)

• Cervical Range of Motion (cROM).

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

• Procedure Believability Questionnaire

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

Other Outcomes (2)

• Cervical Muscle Electromyographic (EMG) Activity

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

• Patient Satisfaction Questionnaire

  Day 14 (Study Visit 5)

Study Arms (3)

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.

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.

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.

Procedure: Manual Cervical Distraction

Interventions

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.

Manual Cervical Distraction High Force; Manual Cervical Distraction Low Force; Manual Cervical Distraction Medium Force

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• Loyola University: collaborator

Study Sites (1)

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

Location

Related Publications (6)

• 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.

  PMID: 25237767 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.

  PMID: 25344427 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.

  PMID: 24023587 BACKGROUND

• 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.

  PMID: 25452013 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.

  PMID: 26044576 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.

  RESULT

Related Links

• Training and certification of doctors of chiropractic in delivering manual cervical traction forces: results of a longitudinal observational study.
• Eligibility determination for clinical trials: development of a case review process at a chiropractic research center.
• Intradiscal Pressure Changes during Manual Cervical Distraction: A Cadaveric Study.
• Clinician proficiency in delivering manual treatment for neck pain within specified force ranges.
• Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Maruti R. Gudavalli, PhD
• Organization: Palmer College of Chiropractic

gudavalli_r@palmer.edu

563-884-5260

Study Officials

• Maruti R. Gudavalli, PhD

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: January 10, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 4, 2018
• Results First Posted: January 4, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)