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Joint Mobilization vs Massage for Chronic Mechanical Neck Pain: A Pilot Study to Assess Recruitment Strategies and Estimate Outcome Measure Variability

Abstract Objective The purpose of this study was to determine the feasibility of a trial comparing cervical spine mobilization and massage as adjuncts to usual physical therapy treatments (superficial heat and head and neck posture education) for chronic neck pain. Specific objectives were to assess...

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Published in:Journal of manipulative and physiological therapeutics 2010-11, Vol.33 (9), p.644-651
Main Authors: Madson, Timothy J., PT, MS, OCS, Cieslak, Kathryn R., PT, DSc, OCS, Gay, Ralph E., DC, MD
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creator Madson, Timothy J., PT, MS, OCS
Cieslak, Kathryn R., PT, DSc, OCS
Gay, Ralph E., DC, MD
description Abstract Objective The purpose of this study was to determine the feasibility of a trial comparing cervical spine mobilization and massage as adjuncts to usual physical therapy treatments (superficial heat and head and neck posture education) for chronic neck pain. Specific objectives were to assess procedures and recruitment strategies and estimate the variability of the Neck Disability Index (NDI) and visual analog scale (VAS) in a population of subjects with chronic nonspecific neck pain and calculate a sample size for a definitive trial. Methods Subjects with nonspecific chronic neck pain (≥3 months) were randomized to receive either sedative massage or cervical spine joint mobilization in addition to postural education and home exercises. Neck Disability Index (primary outcome) and pain VAS scores were recorded for pretreatment, posttreatment, and change scores within each group to estimate effect size. Recruitment and follow-up success rates were tracked. Results Sixty potential subjects were screened: 34 were eligible and 23 were enrolled. The primary reason for not participating was the unwillingness to commit to the treatment schedule. Twenty subjects completed all (12) treatments. Three subjects discontinued treatment because they become asymptomatic. Pre and post mean NDI and VAS scores for the group receiving joint mobilization were 13.54/5.64 and 40.91/16.54, respectively. Pre and post mean NDI and VAS for the group receiving massage were 12.75/8.08 and 29.42/20.91, respectively. Several problems were encountered, and possible solutions were identified. Recruitment difficulties required alteration of the recruitment strategy. Conclusion A full scale trial is feasible if appropriate changes are made in recruitment strategy including recruiting from a wider referral base, direct recruitment from the community, and/or expanding the study to multiple sites. A clinical trial will require 66 subjects per group to have a power of 80% to detect a 2-point difference in NDI score. This sample size will also provide more than 80% power to detect a 10-point difference in pain (VAS) between groups. Recruitment goals will be 76 per group to allow for dropouts.
doi_str_mv 10.1016/j.jmpt.2010.08.008
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Specific objectives were to assess procedures and recruitment strategies and estimate the variability of the Neck Disability Index (NDI) and visual analog scale (VAS) in a population of subjects with chronic nonspecific neck pain and calculate a sample size for a definitive trial. Methods Subjects with nonspecific chronic neck pain (≥3 months) were randomized to receive either sedative massage or cervical spine joint mobilization in addition to postural education and home exercises. Neck Disability Index (primary outcome) and pain VAS scores were recorded for pretreatment, posttreatment, and change scores within each group to estimate effect size. Recruitment and follow-up success rates were tracked. Results Sixty potential subjects were screened: 34 were eligible and 23 were enrolled. The primary reason for not participating was the unwillingness to commit to the treatment schedule. Twenty subjects completed all (12) treatments. Three subjects discontinued treatment because they become asymptomatic. Pre and post mean NDI and VAS scores for the group receiving joint mobilization were 13.54/5.64 and 40.91/16.54, respectively. Pre and post mean NDI and VAS for the group receiving massage were 12.75/8.08 and 29.42/20.91, respectively. Several problems were encountered, and possible solutions were identified. Recruitment difficulties required alteration of the recruitment strategy. Conclusion A full scale trial is feasible if appropriate changes are made in recruitment strategy including recruiting from a wider referral base, direct recruitment from the community, and/or expanding the study to multiple sites. A clinical trial will require 66 subjects per group to have a power of 80% to detect a 2-point difference in NDI score. This sample size will also provide more than 80% power to detect a 10-point difference in pain (VAS) between groups. Recruitment goals will be 76 per group to allow for dropouts.</description><identifier>ISSN: 0161-4754</identifier><identifier>EISSN: 1532-6586</identifier><identifier>DOI: 10.1016/j.jmpt.2010.08.008</identifier><identifier>PMID: 21109054</identifier><language>eng</language><publisher>United States: Mosby, Inc</publisher><subject>Chronic Disease ; Disability Evaluation ; Exercise Therapy ; Female ; Humans ; Male ; Manipulation, Orthopedic ; Massage ; Middle Aged ; Musculoskeletal Manipulations ; Neck Pain ; Neck Pain - therapy ; Pain Measurement ; Patient Selection ; Physical Medicine and Rehabilitation ; Pilot Projects ; Posture ; Randomized Controlled Trials as Topic - methods ; Treatment Outcome</subject><ispartof>Journal of manipulative and physiological therapeutics, 2010-11, Vol.33 (9), p.644-651</ispartof><rights>National University of Health Sciences</rights><rights>2010 National University of Health Sciences</rights><rights>Copyright © 2010 National University of Health Sciences. Published by Mosby, Inc. 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Specific objectives were to assess procedures and recruitment strategies and estimate the variability of the Neck Disability Index (NDI) and visual analog scale (VAS) in a population of subjects with chronic nonspecific neck pain and calculate a sample size for a definitive trial. Methods Subjects with nonspecific chronic neck pain (≥3 months) were randomized to receive either sedative massage or cervical spine joint mobilization in addition to postural education and home exercises. Neck Disability Index (primary outcome) and pain VAS scores were recorded for pretreatment, posttreatment, and change scores within each group to estimate effect size. Recruitment and follow-up success rates were tracked. Results Sixty potential subjects were screened: 34 were eligible and 23 were enrolled. The primary reason for not participating was the unwillingness to commit to the treatment schedule. Twenty subjects completed all (12) treatments. Three subjects discontinued treatment because they become asymptomatic. Pre and post mean NDI and VAS scores for the group receiving joint mobilization were 13.54/5.64 and 40.91/16.54, respectively. Pre and post mean NDI and VAS for the group receiving massage were 12.75/8.08 and 29.42/20.91, respectively. Several problems were encountered, and possible solutions were identified. Recruitment difficulties required alteration of the recruitment strategy. Conclusion A full scale trial is feasible if appropriate changes are made in recruitment strategy including recruiting from a wider referral base, direct recruitment from the community, and/or expanding the study to multiple sites. A clinical trial will require 66 subjects per group to have a power of 80% to detect a 2-point difference in NDI score. This sample size will also provide more than 80% power to detect a 10-point difference in pain (VAS) between groups. Recruitment goals will be 76 per group to allow for dropouts.</description><subject>Chronic Disease</subject><subject>Disability Evaluation</subject><subject>Exercise Therapy</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Manipulation, Orthopedic</subject><subject>Massage</subject><subject>Middle Aged</subject><subject>Musculoskeletal Manipulations</subject><subject>Neck Pain</subject><subject>Neck Pain - therapy</subject><subject>Pain Measurement</subject><subject>Patient Selection</subject><subject>Physical Medicine and Rehabilitation</subject><subject>Pilot Projects</subject><subject>Posture</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Treatment Outcome</subject><issn>0161-4754</issn><issn>1532-6586</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><recordid>eNp9Uk1vEzEUtBCIhsIf4IB847Tp8344DkJIUVQoqKEVBcTN8nrftk5318HPWyn8Ef4uXlI4cOBk63lm9MYzjD0XMBcg5Ml2vu13cZ5DGoCaA6gHbCaqIs9kpeRDNksgkZWLqjxiT4i2ALAsluoxO8qFgCVU5Yz9_ODdEPnG165zP0x0fuB3xDeGyFwjb33g65vgB2f5Bu2NSRfT8Y9ob_mlccMrvuKXrvORX8Wx2fPo-YoIifgntGF0scdhegsm4rVD4mZo-ClF16cBvxij9T0mZUNjQP7VBGemReL-KXvUmo7w2f15zL68Pf28PsvOL969X6_OM1sKiJmSRSkk1AsphKrKElSd_DZtLUEUhYUmz6VUi6URclHWdSWUkhJbUyOWra3a4pi9POjugv8-IkXdO7LYdWZAP5JWokqyUlUJmR-QNniigK3ehWQj7LUAPeWht3rKQ095aFA65ZFIL-7lx7rH5i_lTwAJ8PoAwGTyzmHQZB0OFhsX0EbdePd__Tf_0G3nfmd0i3ukrR_DkL5PC025Bn01NWIqhEhdyEF-K34BWniyGQ</recordid><startdate>20101101</startdate><enddate>20101101</enddate><creator>Madson, Timothy J., PT, MS, OCS</creator><creator>Cieslak, Kathryn R., PT, DSc, OCS</creator><creator>Gay, Ralph E., DC, MD</creator><general>Mosby, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20101101</creationdate><title>Joint Mobilization vs Massage for Chronic Mechanical Neck Pain: A Pilot Study to Assess Recruitment Strategies and Estimate Outcome Measure Variability</title><author>Madson, Timothy J., PT, MS, OCS ; Cieslak, Kathryn R., PT, DSc, OCS ; Gay, Ralph E., DC, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-8634160b7611854408b475dfb60133c0d2266879a1674bb518866efabee4fc5f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Chronic Disease</topic><topic>Disability Evaluation</topic><topic>Exercise Therapy</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Manipulation, Orthopedic</topic><topic>Massage</topic><topic>Middle Aged</topic><topic>Musculoskeletal Manipulations</topic><topic>Neck Pain</topic><topic>Neck Pain - therapy</topic><topic>Pain Measurement</topic><topic>Patient Selection</topic><topic>Physical Medicine and Rehabilitation</topic><topic>Pilot Projects</topic><topic>Posture</topic><topic>Randomized Controlled Trials as Topic - methods</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Madson, Timothy J., PT, MS, OCS</creatorcontrib><creatorcontrib>Cieslak, Kathryn R., PT, DSc, OCS</creatorcontrib><creatorcontrib>Gay, Ralph E., DC, MD</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of manipulative and physiological therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Madson, Timothy J., PT, MS, OCS</au><au>Cieslak, Kathryn R., PT, DSc, OCS</au><au>Gay, Ralph E., DC, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Joint Mobilization vs Massage for Chronic Mechanical Neck Pain: A Pilot Study to Assess Recruitment Strategies and Estimate Outcome Measure Variability</atitle><jtitle>Journal of manipulative and physiological therapeutics</jtitle><addtitle>J Manipulative Physiol Ther</addtitle><date>2010-11-01</date><risdate>2010</risdate><volume>33</volume><issue>9</issue><spage>644</spage><epage>651</epage><pages>644-651</pages><issn>0161-4754</issn><eissn>1532-6586</eissn><abstract>Abstract Objective The purpose of this study was to determine the feasibility of a trial comparing cervical spine mobilization and massage as adjuncts to usual physical therapy treatments (superficial heat and head and neck posture education) for chronic neck pain. Specific objectives were to assess procedures and recruitment strategies and estimate the variability of the Neck Disability Index (NDI) and visual analog scale (VAS) in a population of subjects with chronic nonspecific neck pain and calculate a sample size for a definitive trial. Methods Subjects with nonspecific chronic neck pain (≥3 months) were randomized to receive either sedative massage or cervical spine joint mobilization in addition to postural education and home exercises. Neck Disability Index (primary outcome) and pain VAS scores were recorded for pretreatment, posttreatment, and change scores within each group to estimate effect size. Recruitment and follow-up success rates were tracked. Results Sixty potential subjects were screened: 34 were eligible and 23 were enrolled. The primary reason for not participating was the unwillingness to commit to the treatment schedule. Twenty subjects completed all (12) treatments. Three subjects discontinued treatment because they become asymptomatic. Pre and post mean NDI and VAS scores for the group receiving joint mobilization were 13.54/5.64 and 40.91/16.54, respectively. Pre and post mean NDI and VAS for the group receiving massage were 12.75/8.08 and 29.42/20.91, respectively. Several problems were encountered, and possible solutions were identified. Recruitment difficulties required alteration of the recruitment strategy. Conclusion A full scale trial is feasible if appropriate changes are made in recruitment strategy including recruiting from a wider referral base, direct recruitment from the community, and/or expanding the study to multiple sites. A clinical trial will require 66 subjects per group to have a power of 80% to detect a 2-point difference in NDI score. This sample size will also provide more than 80% power to detect a 10-point difference in pain (VAS) between groups. 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subjects Chronic Disease
Disability Evaluation
Exercise Therapy
Female
Humans
Male
Manipulation, Orthopedic
Massage
Middle Aged
Musculoskeletal Manipulations
Neck Pain
Neck Pain - therapy
Pain Measurement
Patient Selection
Physical Medicine and Rehabilitation
Pilot Projects
Posture
Randomized Controlled Trials as Topic - methods
Treatment Outcome
title Joint Mobilization vs Massage for Chronic Mechanical Neck Pain: A Pilot Study to Assess Recruitment Strategies and Estimate Outcome Measure Variability
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