The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial

Jacek Cholewicki; John M. Popovich; N. Peter Reeves; Lisa A. DeStefano; Jacob J. Rowan; Timothy J. Francisco; Lawrence L. Prokop; Mathew A. Zatkin; Angela S. Lee; Alla Sikorskii; Pramod K. Pathak; Jongeun Choi; Clark J. Radcliffe; Ahmed Ramadan

doi:10.1002/pmrj.12732

The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial

Jacek Cholewicki, John M. Popovich, N. Peter Reeves, Lisa A. DeStefano, Jacob J. Rowan, Timothy J. Francisco, Lawrence L. Prokop, Mathew A. Zatkin, Angela S. Lee, Alla Sikorskii, Pramod K. Pathak, Jongeun Choi, Clark J. Radcliffe, Ahmed Ramadan

Department of Mechanical Engineering

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Background: Neck pain (NP) affects up to 70% of individuals at some point in their lives. Systematic reviews indicate that manual treatments can be moderately effective in the management of chronic, nonspecific NP. However, there is a paucity of studies specifically evaluating the efficacy of osteopathic manipulative treatment (OMT). Objective: To evaluate the efficacy of OMT in reducing pain and disability in patients with chronic NP. Design: Single-blinded, cross-over, randomized-controlled trial. Setting: University-based, osteopathic manipulative medicine outpatient clinic. Participants: Ninety-seven participants, 21 to 65 years of age, with chronic, nonspecific NP. Interventions: Participants were randomized to two trial arms: immediate OMT intervention or waiting period first. The intervention consisted of three to four OMT sessions over 4 to 6 weeks, after which the participants switched groups. Main Outcome Measures: Primary outcome measures were pain intensity (average and current) on the numerical rating scale and Neck Disability Index. Secondary outcomes included Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) health domains and Fear Avoidance Beliefs Questionnaire. Outcomes obtained prior to the cross-over allocation were evaluated using general linear models and after adjusting for baseline values. Results: A total of 38 and 37 participants were available for the analysis in the OMT and waiting period groups, respectively. The results showed significantly better primary outcomes in the immediate OMT group for reductions in average pain (−1.02, 95% confidence interval [CI] −1.72, −0.32; p =.005), current pain (−1.02, 95% CI −1.75, −0.30; p =.006), disability (−5.30%, 95% CI −9.2%, −1.3%; p =.010) and improved secondary outcomes (PROMIS) related to sleep (−3.25, 95% CI −6.95, −1.54; p =.003), fatigue (−3.26, 95% CI −6.04, −0.48; p =.022), and depression (−2.59, 95% CI −4.73, −0.45; p =.018). The effect sizes were in the clinically meaningful range between 0.5 and 1 standard deviation. No study-related serious adverse events were reported. Conclusions: OMT is relatively safe and effective in reducing pain and disability along with improving sleep, fatigue, and depression in patients with chronic NP immediately following treatment delivered over approximately 4 to 6 weeks.

Original language	English
Pages (from-to)	1417-1429
Number of pages	13
Journal	PM and R
Volume	14
Issue number	12
DOIs	https://doi.org/10.1002/pmrj.12732
Publication status	Published - 2022 Dec

Bibliographical note

Funding Information:
The authors would like to thank Cody Priess, PhD, for his significant role in the development of the head/neck motor control tests. We would also like to pay our gratitude and respects to our late colleague, Timothy Francisco, DO, whose dedication and contribution to the osteopathic profession also made this work possible. This publication was made possible by grant number U19AT006057 from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NCCIH.

Publisher Copyright:
© 2021 American Academy of Physical Medicine and Rehabilitation.

All Science Journal Classification (ASJC) codes

Physical Therapy, Sports Therapy and Rehabilitation
Rehabilitation
Neurology
Clinical Neurology

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10.1002/pmrj.12732

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Cholewicki, J., Popovich, J. M., Reeves, N. P., DeStefano, L. A., Rowan, J. J., Francisco, T. J., Prokop, L. L., Zatkin, M. A., Lee, A. S., Sikorskii, A., Pathak, P. K., Choi, J., Radcliffe, C. J., & Ramadan, A. (2022). The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial. PM and R, 14(12), 1417-1429. https://doi.org/10.1002/pmrj.12732

@article{8d94583ebbd94901a4c533861399382b,

title = "The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial",

abstract = "Background: Neck pain (NP) affects up to 70% of individuals at some point in their lives. Systematic reviews indicate that manual treatments can be moderately effective in the management of chronic, nonspecific NP. However, there is a paucity of studies specifically evaluating the efficacy of osteopathic manipulative treatment (OMT). Objective: To evaluate the efficacy of OMT in reducing pain and disability in patients with chronic NP. Design: Single-blinded, cross-over, randomized-controlled trial. Setting: University-based, osteopathic manipulative medicine outpatient clinic. Participants: Ninety-seven participants, 21 to 65 years of age, with chronic, nonspecific NP. Interventions: Participants were randomized to two trial arms: immediate OMT intervention or waiting period first. The intervention consisted of three to four OMT sessions over 4 to 6 weeks, after which the participants switched groups. Main Outcome Measures: Primary outcome measures were pain intensity (average and current) on the numerical rating scale and Neck Disability Index. Secondary outcomes included Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) health domains and Fear Avoidance Beliefs Questionnaire. Outcomes obtained prior to the cross-over allocation were evaluated using general linear models and after adjusting for baseline values. Results: A total of 38 and 37 participants were available for the analysis in the OMT and waiting period groups, respectively. The results showed significantly better primary outcomes in the immediate OMT group for reductions in average pain (−1.02, 95% confidence interval [CI] −1.72, −0.32; p =.005), current pain (−1.02, 95% CI −1.75, −0.30; p =.006), disability (−5.30%, 95% CI −9.2%, −1.3%; p =.010) and improved secondary outcomes (PROMIS) related to sleep (−3.25, 95% CI −6.95, −1.54; p =.003), fatigue (−3.26, 95% CI −6.04, −0.48; p =.022), and depression (−2.59, 95% CI −4.73, −0.45; p =.018). The effect sizes were in the clinically meaningful range between 0.5 and 1 standard deviation. No study-related serious adverse events were reported. Conclusions: OMT is relatively safe and effective in reducing pain and disability along with improving sleep, fatigue, and depression in patients with chronic NP immediately following treatment delivered over approximately 4 to 6 weeks.",

author = "Jacek Cholewicki and Popovich, {John M.} and Reeves, {N. Peter} and DeStefano, {Lisa A.} and Rowan, {Jacob J.} and Francisco, {Timothy J.} and Prokop, {Lawrence L.} and Zatkin, {Mathew A.} and Lee, {Angela S.} and Alla Sikorskii and Pathak, {Pramod K.} and Jongeun Choi and Radcliffe, {Clark J.} and Ahmed Ramadan",

note = "Funding Information: The authors would like to thank Cody Priess, PhD, for his significant role in the development of the head/neck motor control tests. We would also like to pay our gratitude and respects to our late colleague, Timothy Francisco, DO, whose dedication and contribution to the osteopathic profession also made this work possible. This publication was made possible by grant number U19AT006057 from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NCCIH. Publisher Copyright: {\textcopyright} 2021 American Academy of Physical Medicine and Rehabilitation.",

year = "2022",

month = dec,

doi = "10.1002/pmrj.12732",

language = "English",

volume = "14",

pages = "1417--1429",

journal = "PM and R",

issn = "1934-1482",

publisher = "Elsevier Inc.",

number = "12",

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Cholewicki, J, Popovich, JM, Reeves, NP, DeStefano, LA, Rowan, JJ, Francisco, TJ, Prokop, LL, Zatkin, MA, Lee, AS, Sikorskii, A, Pathak, PK, Choi, J, Radcliffe, CJ & Ramadan, A 2022, 'The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial', PM and R, vol. 14, no. 12, pp. 1417-1429. https://doi.org/10.1002/pmrj.12732

TY - JOUR

T1 - The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain

T2 - A single-blinded randomized controlled trial

AU - Cholewicki, Jacek

AU - Popovich, John M.

AU - Reeves, N. Peter

AU - DeStefano, Lisa A.

AU - Rowan, Jacob J.

AU - Francisco, Timothy J.

AU - Prokop, Lawrence L.

AU - Zatkin, Mathew A.

AU - Lee, Angela S.

AU - Sikorskii, Alla

AU - Pathak, Pramod K.

AU - Choi, Jongeun

AU - Radcliffe, Clark J.

AU - Ramadan, Ahmed

N1 - Funding Information: The authors would like to thank Cody Priess, PhD, for his significant role in the development of the head/neck motor control tests. We would also like to pay our gratitude and respects to our late colleague, Timothy Francisco, DO, whose dedication and contribution to the osteopathic profession also made this work possible. This publication was made possible by grant number U19AT006057 from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NCCIH. Publisher Copyright: © 2021 American Academy of Physical Medicine and Rehabilitation.

PY - 2022/12

Y1 - 2022/12

N2 - Background: Neck pain (NP) affects up to 70% of individuals at some point in their lives. Systematic reviews indicate that manual treatments can be moderately effective in the management of chronic, nonspecific NP. However, there is a paucity of studies specifically evaluating the efficacy of osteopathic manipulative treatment (OMT). Objective: To evaluate the efficacy of OMT in reducing pain and disability in patients with chronic NP. Design: Single-blinded, cross-over, randomized-controlled trial. Setting: University-based, osteopathic manipulative medicine outpatient clinic. Participants: Ninety-seven participants, 21 to 65 years of age, with chronic, nonspecific NP. Interventions: Participants were randomized to two trial arms: immediate OMT intervention or waiting period first. The intervention consisted of three to four OMT sessions over 4 to 6 weeks, after which the participants switched groups. Main Outcome Measures: Primary outcome measures were pain intensity (average and current) on the numerical rating scale and Neck Disability Index. Secondary outcomes included Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) health domains and Fear Avoidance Beliefs Questionnaire. Outcomes obtained prior to the cross-over allocation were evaluated using general linear models and after adjusting for baseline values. Results: A total of 38 and 37 participants were available for the analysis in the OMT and waiting period groups, respectively. The results showed significantly better primary outcomes in the immediate OMT group for reductions in average pain (−1.02, 95% confidence interval [CI] −1.72, −0.32; p =.005), current pain (−1.02, 95% CI −1.75, −0.30; p =.006), disability (−5.30%, 95% CI −9.2%, −1.3%; p =.010) and improved secondary outcomes (PROMIS) related to sleep (−3.25, 95% CI −6.95, −1.54; p =.003), fatigue (−3.26, 95% CI −6.04, −0.48; p =.022), and depression (−2.59, 95% CI −4.73, −0.45; p =.018). The effect sizes were in the clinically meaningful range between 0.5 and 1 standard deviation. No study-related serious adverse events were reported. Conclusions: OMT is relatively safe and effective in reducing pain and disability along with improving sleep, fatigue, and depression in patients with chronic NP immediately following treatment delivered over approximately 4 to 6 weeks.

AB - Background: Neck pain (NP) affects up to 70% of individuals at some point in their lives. Systematic reviews indicate that manual treatments can be moderately effective in the management of chronic, nonspecific NP. However, there is a paucity of studies specifically evaluating the efficacy of osteopathic manipulative treatment (OMT). Objective: To evaluate the efficacy of OMT in reducing pain and disability in patients with chronic NP. Design: Single-blinded, cross-over, randomized-controlled trial. Setting: University-based, osteopathic manipulative medicine outpatient clinic. Participants: Ninety-seven participants, 21 to 65 years of age, with chronic, nonspecific NP. Interventions: Participants were randomized to two trial arms: immediate OMT intervention or waiting period first. The intervention consisted of three to four OMT sessions over 4 to 6 weeks, after which the participants switched groups. Main Outcome Measures: Primary outcome measures were pain intensity (average and current) on the numerical rating scale and Neck Disability Index. Secondary outcomes included Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) health domains and Fear Avoidance Beliefs Questionnaire. Outcomes obtained prior to the cross-over allocation were evaluated using general linear models and after adjusting for baseline values. Results: A total of 38 and 37 participants were available for the analysis in the OMT and waiting period groups, respectively. The results showed significantly better primary outcomes in the immediate OMT group for reductions in average pain (−1.02, 95% confidence interval [CI] −1.72, −0.32; p =.005), current pain (−1.02, 95% CI −1.75, −0.30; p =.006), disability (−5.30%, 95% CI −9.2%, −1.3%; p =.010) and improved secondary outcomes (PROMIS) related to sleep (−3.25, 95% CI −6.95, −1.54; p =.003), fatigue (−3.26, 95% CI −6.04, −0.48; p =.022), and depression (−2.59, 95% CI −4.73, −0.45; p =.018). The effect sizes were in the clinically meaningful range between 0.5 and 1 standard deviation. No study-related serious adverse events were reported. Conclusions: OMT is relatively safe and effective in reducing pain and disability along with improving sleep, fatigue, and depression in patients with chronic NP immediately following treatment delivered over approximately 4 to 6 weeks.

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The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial

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