- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477145
Effect of Body Mind Exercises and Specific Neck Exercises in Chronic Mechanical Neck Pain (BME-SNE)
Study Overview
Status
Conditions
Detailed Description
Chronic mechanical neck pain is one of the most common musculoskeletal disorders affecting middle-aged and older adults and is associated with pain, reduced cervical mobility, functional disability, and decreased quality of life. Exercise therapy is widely recommended as a first-line conservative treatment for chronic neck pain. Previous studies have shown that both specific neck exercises and general physical activity can reduce pain and improve functional outcomes.
Body-mind exercises, which combine physical movement with focused attention and breathing control, may provide additional benefits by improving both physical and psychological aspects of chronic pain. However, the comparative effectiveness of body-mind exercises and specific neck exercises when combined with conventional physical therapy remains unclear.
The aim of this randomized controlled trial is to investigate the effect of body-mind exercises and specific neck exercises on pain intensity, functional disability, cervical range of motion, isometric neck muscle strength, and quality of life in individuals with chronic mechanical neck pain.
A total of 80 participants aged 50 to 65 years with chronic mechanical neck pain will be recruited and randomly allocated into four groups using a parallel-group design. Group A will receive conventional physical therapy alone. Group B will receive conventional physical therapy combined with body-mind exercises in the form of mindful aerobic treadmill walking. Group C will receive conventional physical therapy combined with specific cervical and scapular stabilization exercises. Group D will receive a combination of conventional physical therapy, body-mind exercises, and specific neck exercises.
All interventions will be performed over a treatment period of six weeks. Outcome measures will include pain intensity measured by the Numeric Pain Rating Scale (NPRS), functional disability assessed by the Neck Disability Index (NDI), cervical range of motion measured using a Cervical Range of Motion (CROM) device, isometric neck muscle strength measured using a handheld dynamometer, and quality of life assessed using the RAND-36 Health Survey. Measurements will be taken before the intervention and after completion of the six-week treatment period.
The results of this study will help determine the most effective exercise approach for improving clinical outcomes in patients with chronic mechanical neck pain and may provide evidence to guide physical therapy practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: RAMY I KOMIR, MSc
- Phone Number: +966553277511
- Email: rami33332@yahoo.com
Study Contact Backup
- Name: RAMY I KOMIR, MSc
- Phone Number: +966566060994
- Email: rami33332@yahoo.com
Study Locations
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Cairo, Egypt, 12613
- Faculity of Physical Therapy in Cairo University
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Contact:
- RAMY GNADY KOMIR, MSc
- Phone Number: +966553277511
- Email: rami33332@yahoo.com
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Contact:
- MOAAZ RAGAB EL SAKKA, PhD
- Phone Number: +201007210132
- Email: moaaz.elsakka@gmail.com
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Principal Investigator:
- RAMY I KOMIR, MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged between 50-65 years
- Diagnosis of chronic mechanical neck pain (pain duration ≥ 3 months)
- Pain intensity of at least 3/10 on the NPRS
Exclusion Criteria:
- History of cervical surgery
- Specific neck conditions (fractures, neoplasm, infection)
- Pregnancy
- Severe cardiopulmonary disease or other systemic illness affecting participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: Conventional physical therapy group (Control group)
Group A will receive conventional therapy which includes: heat therapy (infrared) for 10 minutes, massage therapy 10 min, stretching of neck (Scalene, SCM, UFT, Levator scapulae) and pectoral muscles 20 min.
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conventional therapy which includes: heat therapy (infrared) for 10 minutes, massage therapy 10 min, stretching of neck (Scalene, SCM, UFT, Levator scapulae) and pectoral muscles 20 min.
|
|
Experimental: Group B: Body mind exercises group (mindful aerobic exercises)
Group B will receive conventional physical therapy (infrared, massage, and neck stretching) in addition to Body mind exercises (mindful aerobic exercises).
The aerobic exercise will be performed at an intensity of at least 60% of maximal oxygen consumption (VO₂ max) to effectively improve cardiorespiratory fitness.
The program will include treadmill walking 30 minutes.
|
conventional therapy which includes: heat therapy (infrared) for 10 minutes, massage therapy 10 min, stretching of neck (Scalene, SCM, UFT, Levator scapulae) and pectoral muscles 20 min.
Group B will receive conventional physical therapy (infrared, massage, and neck stretching) in addition to Body mind exercises (mindful aerobic exercises).
The aerobic exercise will be performed at an intensity of at least 60% of maximal oxygen consumption (VO₂ max) to effectively improve cardiorespiratory fitness.
The program will include treadmill walking 30 minutes.
|
|
Experimental: Group C: specific neck exercise group
Group C will receive conventional therapy in addition to specific neck exercises.
Specific exercises will include: cervical and scapular stabilization exercises.
|
conventional therapy which includes: heat therapy (infrared) for 10 minutes, massage therapy 10 min, stretching of neck (Scalene, SCM, UFT, Levator scapulae) and pectoral muscles 20 min.
Group C will receive conventional therapy in addition to specific neck exercises.
Specific exercises will include: cervical and scapular stabilization exercises.
|
|
Experimental: Group D : Combined exercise group.
Group D will receive conventional therapy in addition to mindful aerobic exercises, cervical and scapular stabilization.
|
conventional therapy which includes: heat therapy (infrared) for 10 minutes, massage therapy 10 min, stretching of neck (Scalene, SCM, UFT, Levator scapulae) and pectoral muscles 20 min.
Group B will receive conventional physical therapy (infrared, massage, and neck stretching) in addition to Body mind exercises (mindful aerobic exercises).
The aerobic exercise will be performed at an intensity of at least 60% of maximal oxygen consumption (VO₂ max) to effectively improve cardiorespiratory fitness.
The program will include treadmill walking 30 minutes.
Group C will receive conventional therapy in addition to specific neck exercises.
Specific exercises will include: cervical and scapular stabilization exercises.
Group D will receive conventional therapy in addition to mindful aerobic exercises, cervical and scapular stabilization exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: (pre-intervention) and after 6 weeks (post-intervention).
|
Numeric Pain Rating Scale (NPRS, Arabic version) 0-10 scale; validated for Arabic-speaking populations (Alghadir et al., 2016)
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(pre-intervention) and after 6 weeks (post-intervention).
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Quality of Life Measured by RAND-36 Health Survey
Time Frame: (pre-intervention) and after 6 weeks (post-intervention).
|
Measures physical, emotional, and social functioning .
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(pre-intervention) and after 6 weeks (post-intervention).
|
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Functional Disability
Time Frame: (pre-intervention) and after 6 weeks (post-intervention).
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Neck Disability Index (NDI, Arabic version) 10-item questionnaire.
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(pre-intervention) and after 6 weeks (post-intervention).
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Cervical ROM
Time Frame: (pre-intervention) and after 6 weeks (post-intervention).
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CROM device.
Measures flexion, extension, lateral flexion, rotation; 3 repetitions per movement (Kiatkulanusorn et al., 2023).
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(pre-intervention) and after 6 weeks (post-intervention).
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Isometric Neck Strength
Time Frame: (pre-intervention) and after 6 weeks (post-intervention).
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Handheld dynamometer (HHD) Flexion (forehead), Extension (occiput), 3 maximal contractions of 5 sec each, average recorded (Ghamkhar et al., 2011)
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(pre-intervention) and after 6 weeks (post-intervention).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: RAMY I KOMIR, MSc, Cairo University
Publications and helpful links
General Publications
- Gross A, Kay TM, Paquin JP, Blanchette S, Lalonde P, Christie T, Dupont G, Graham N, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Hoving JL, Bronfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1(1):CD004250. doi: 10.1002/14651858.CD004250.pub5.
- Gross AR, Paquin JP, Dupont G, Blanchette S, Lalonde P, Cristie T, Graham N, Kay TM, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Santaguida PL, Yee AJ, Radisic GG, Hoving JL, Bronfort G; Cervical Overview Group. Exercises for mechanical neck disorders: A Cochrane review update. Man Ther. 2016 Aug;24:25-45. doi: 10.1016/j.math.2016.04.005. Epub 2016 Apr 20.
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- Lauche R, Stumpe C, Fehr J, Cramer H, Cheng YW, Wayne PM, Rampp T, Langhorst J, Dobos G. The Effects of Tai Chi and Neck Exercises in the Treatment of Chronic Nonspecific Neck Pain: A Randomized Controlled Trial. J Pain. 2016 Sep;17(9):1013-27. doi: 10.1016/j.jpain.2016.06.004. Epub 2016 Jun 23.
- Alaparthi GK, Augustine AJ, Anand R, Mahale A. Comparison of Diaphragmatic Breathing Exercise, Volume and Flow Incentive Spirometry, on Diaphragm Excursion and Pulmonary Function in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial. Minim Invasive Surg. 2016;2016:1967532. doi: 10.1155/2016/1967532. Epub 2016 Jul 21.
- Hoy DG, Protani M, De R, Buchbinder R. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):783-92. doi: 10.1016/j.berh.2011.01.019.
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- Alagingi NK. Chronic neck pain and postural rehabilitation: A literature review. J Bodyw Mov Ther. 2022 Oct;32:201-206. doi: 10.1016/j.jbmt.2022.04.017. Epub 2022 Apr 20.
- Kisner, C., & Colby, L. A. (2017). Therapeutic Exercise: Foundations and Techniques (7th ed.). F.A. Davis Company.
- IBRAHIM M. ELNAGGAR, Ph.D., H. S. E. M., & Sh. ABDELSALAM, Ph.D., M. (2022). Cervical Stabilization Exercises Versus Scapular Stabilization Exercises in Treatment of Chronic Mechanical Neck Pain. The Medical Journal of Cairo University, 90(9), 1729-1735. doi: 10.21608/mjcu.2022.272095
- Wewege MA, Jones MD. Exercise-Induced Hypoalgesia in Healthy Individuals and People With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. J Pain. 2021 Jan;22(1):21-31. doi: 10.1016/j.jpain.2020.04.003. Epub 2020 Jun 26.
- Rosa MABMV, Bastos RM, Vieira Rosa DK, Scola LFC, Albertini R, Yi LC. General exercises are not superior to specific exercises for pain and functional disability in individuals with chronic nonspecific neck pain. A systematic review and meta-analysis. J Bodyw Mov Ther. 2024 Oct;40:1957-1966. doi: 10.1016/j.jbmt.2024.10.013. Epub 2024 Oct 18.
- Valenza-Pena G, Martin-Nunez J, Heredia-Ciuro A, Navas-Otero A, Lopez-Lopez L, Valenza MC, Cabrera-Martos I. Effectiveness of Self-Care Education for Chronic Neck Pain: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2023 Dec 13;11(24):3161. doi: 10.3390/healthcare11243161.
- Yu LJ, Yan X, Kim TH. Effects of combined jaw and cervicoscapular exercises on mouth opening and muscle properties in cervical extension type. Sci Rep. 2025 May 30;15(1):19049. doi: 10.1038/s41598-025-03846-3.
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- Arsovski D. Effectiveness of Medical Massage in Reducing Neck Pain Among Multiple Occupational Groups: A Longitudinal Study. Int J Ther Massage Bodywork. 2024 Sep 12;17(3):23-30. doi: 10.3822/ijtmb.v17i3.993. eCollection 2024 Sep.
- Sakinepoor A, Cheragh ZA, Degens H, Mazidi M. Neck stabilization exercise and dynamic neuromuscular stabilization reduce pain intensity, forward head angle and muscle activity of employees with chronic non-specific neck pain: A retrospective study. J Exp Orthop. 2025 Feb 28;12(1):e70188. doi: 10.1002/jeo2.70188. eCollection 2025 Jan.
- Price J, Rushton A, Tyros I, Tyros V, Heneghan NR. Effectiveness and optimal dosage of exercise training for chronic non-specific neck pain: A systematic review with a narrative synthesis. PLoS One. 2020 Jun 10;15(6):e0234511. doi: 10.1371/journal.pone.0234511. eCollection 2020.
- Paraskevopoulos E, Koumantakis GA, Papandreou M. A Systematic Review of the Aerobic Exercise Program Variables for Patients with Non-Specific Neck Pain: Effectiveness and Clinical Applications. Healthcare (Basel). 2023 Jan 24;11(3):339. doi: 10.3390/healthcare11030339.
- Oz HE, Duran G, Bayraktar D, Kara M, Solmaz D, Akar S. Effect of cervical stabilization exercises on cervical position error in patients with axial spondyloarthritis: a randomized controlled pilot study. Z Rheumatol. 2024 Feb;83(Suppl 1):48-54. doi: 10.1007/s00393-022-01295-1. Epub 2022 Dec 2.
- Senarath ID, Weerasekara I, Humphries M, Chen KK, Farrell SF, de Zoete RMJ. Physical exercise therapy for chronic non-specific neck pain: protocol for a meta-analysis of individual participant data. Syst Rev. 2025 Feb 17;14(1):43. doi: 10.1186/s13643-025-02789-0.
- Misailidou V, Malliou P, Beneka A, Karagiannidis A, Godolias G. Assessment of patients with neck pain: a review of definitions, selection criteria, and measurement tools. J Chiropr Med. 2010 Jun;9(2):49-59. doi: 10.1016/j.jcm.2010.03.002.
- Granacher U, Bridenbaugh SA, Muehlbauer T, Wehrle A, Kressig RW. Age-related effects on postural control under multi-task conditions. Gerontology. 2011;57(3):247-55. doi: 10.1159/000322196. Epub 2010 Oct 27.
- Artus M, Campbell P, Mallen CD, Dunn KM, van der Windt DA. Generic prognostic factors for musculoskeletal pain in primary care: a systematic review. BMJ Open. 2017 Jan 17;7(1):e012901. doi: 10.1136/bmjopen-2016-012901.
- Korshoj M, Birk Jorgensen M, Lidegaard M, Mortensen OS, Krustrup P, Holtermann A, Sogaard K. Decrease in musculoskeletal pain after 4 and 12 months of an aerobic exercise intervention: a worksite RCT among cleaners. Scand J Public Health. 2018 Dec;46(8):846-853. doi: 10.1177/1403494817717833. Epub 2017 Jul 9.
- Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.
- Kiatkulanusorn S, Luangpon N, Srijunto W, Watechagit S, Pitchayadejanant K, Kuharat S, Beg OA, Suato BP. Analysis of the concurrent validity and reliability of five common clinical goniometric devices. Sci Rep. 2023 Nov 27;13(1):20931. doi: 10.1038/s41598-023-48344-6.
- Kang NY, Im SC, Kim K. Effects of a combination of scapular stabilization and thoracic extension exercises for office workers with forward head posture on the craniovertebral angle, respiration, pain, and disability: A randomized-controlled trial. Turk J Phys Med Rehabil. 2021 Sep 1;67(3):291-299. doi: 10.5606/tftrd.2021.6397. eCollection 2021 Sep.
- Saper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, Keosaian JE, Cerrada CJ, Lemaster CM, Faulkner C, Breuer M, Weinberg J. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.
- Miller J, Gross A, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manual therapy and exercise for neck pain: a systematic review. Man Ther. 2010 Aug;15(4):334-54.
- Alshehri SHS, Reddy RS, ALMohiza MA, Alshahrani MS, Alkhamis BA, Alnakhli HH, Koura GM, Gautam AP, Mukherjee D, Alqhtani RS, Al Adal SY, Alyami AM, Alyazedi FM. Influence of cervical muscle strength and pain severity on functional balance and limits of stability in elderly individuals with chronic nonspecific neck pain: a cross-sectional study. BMC Geriatr. 2025 Jan 9;25(1):18. doi: 10.1186/s12877-024-05670-2.
- Dong Y, Zhang X, Zhao R, Cao L, Kuang X, Yao J. The effects of mind-body exercise on anxiety and depression in older adults: a systematic review and network meta-analysis. Front Psychiatry. 2024 Feb 7;15:1305295. doi: 10.3389/fpsyt.2024.1305295. eCollection 2024.
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Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/006226.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Study Protocol
Information identifier: P.T.REC/012/006226Information comments: The full study protocol is available upon reasonable request from the Principal Investigator. Requests can be directed to the Faculty of Physical Therapy, Cairo University.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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