Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05321654
Other study ID # IRB-FY20-21-1073
Secondary ID UR2201
Status Completed
Phase N/A
First received
Last updated
Start date August 26, 2021
Est. completion date November 4, 2021

Study information

Verified date April 2022
Source Liberty University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized control trial examined the effects of postural education or corrective exercise intervention on the craniovertebral angle (CVA) in young adults with forward head posture (FHP). The objectives were 1: to investigate whether or not a corrective exercise program (CEP) consisting of self-myofascial release (SMR) + stretching; a CEP consisting of SMR + stretching + strengthening; or postural education (PE) had an effect on the CVA; 2. to determine which intervention yielded the greatest postural enhancement if a positive effect was observed in more than one intervention. *[note: SMR is a technique involving the self-application of pressure to fascia and muscle tissue for the purpose of enhancing flexibility, reducing muscle soreness, and influencing muscle relaxation]. It was hypothesized that 4 weeks after receiving either CEP intervention or PE there would be a significant change in the CVA compared to a control group; and that there would be an intervention more effective than the others for improving the CVA. The null hypotheses were: there would be no CVA change after intervention in any of the groups; and there will be no intervention more effective than another for improving the CVA.


Description:

A total of 94 participants responded to invitations to voluntarily participate and completed the Physical Activity Readiness Questionnaire (PAR-Q+), followed by a questionnaire to rate their current stage of change (SOC) from the Transtheoretical Model adapted to assess exercise/postural modification behavior change (this will be discussed further in eligibility section). On this questionnaire, participants also responded to a yes/no question regarding if they have had a recent injury to their head, shoulders, or spine; or have ever been diagnosed with a pathology related to their cervical/thoracic spine or extremities, as part of exclusion criteria for the study. Participants then underwent a head posture screening performed by the primary investigator who is a licensed physical therapist in the Liberty University Biomechanics & Motion Analysis Laboratory with the use of photogrammetry (use of a digital camera and software to measure posture) as described below. Participants were asked to arrive at the lab wearing either a tank top or t-shirt, as well as to have their hair tied back if necessary. Height and weight were measured using a digital scale (Health-o-meter Professional, model 500KL, McCook, IL). Participants were instructed to sit comfortably on a stool with hands resting approximately two-thirds down their thighs with palms supinated and feet flat on the ground with hips and knees at 90 degrees; and to look straight ahead at an opposite wall in the laboratory. A digital camera (Canon Powershot, model SX540, Tokyo, Japan) was mounted and leveled on a tripod (Manfrotto, model 055, Cassola, IT) and placed three meters away from the subject. Two photographs were taken of participant's posture. Immediately after data capture, image files were uploaded into Kinovea video analysis software (version 8.15) for CVA assessment. CVA assessment will be discussed further in outcome measures section. Seventy-nine participants met inclusion criteria (discussed in detail in future section) and were enrolled in the study. Randomization of participant group assignments was completed by the PI using a block randomization generator. Utilizing a sequence created by the block randomizer, the PI placed participants who met inclusion criteria into one of four groups: postural education (PE; n = 20), self-myofascial release + stretching (SMRS; n = 20), self-myofascial release + stretching + strengthening (SMRSS; n = 19), and control group (CG; n = 20). Details of these groups will be provided in future sections. A hard-copy of the sequence generator report was kept concealed in a manila folder and was only opened by the PI during group delegation. Intervention duration was 4 weeks. Two weeks into the study, participants in intervention groups completed a mid-study questionnaire to assess intervention compliance. At the end of the study (after the completion of 4 weeks) participants in intervention groups completed a post-study questionnaire to assess intervention compliance. All study participants were asked to return back to the Biomechanics laboratory after the completion of the 4 week intervention period to undergo follow-up posture screening, which followed the same posture assessment procedures as described above. Declarations of interest: This study was part of the requirements for completion of a Ph.D. dissertation (Concordia University Chicago) by David Titcomb, DPT. Conflicts of interest: none.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date November 4, 2021
Est. primary completion date November 4, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility Inclusion Criteria: - Completion of informed consent - Craniovertebral angle = 53 degrees - Self-rating of Transtheoretical Model stage of change stage = 3/5 Exclusion Criteria: - Any musculoskeletal injury to the head, shoulders, or spine within the last six months - Diagnosis of pathology related to the cervical spine, thoracic spine, or upper extremities - Non-clearance for physical activity based on results of the 2020 PAR-Q+ questionnaire

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Education for Behavior Modification
Please see arm description for a detailed description of the intervention
Corrective Exercise Program
Please see arm description for a detailed description of the intervention

Locations

Country Name City State
United States Liberty University Lynchburg Virginia

Sponsors (2)

Lead Sponsor Collaborator
Liberty University National Academy of Sports Medicine

Country where clinical trial is conducted

United States, 

References & Publications (22)

Abdelhameed AA, Abdel-Aziem AA. Exercise training and postural correction improve upper extremity symptoms among touchscreen smartphone users. Hong Kong Physiother J. 2016 Sep 7;35:37-44. doi: 10.1016/j.hkpj.2016.06.001. eCollection 2016 Dec. — View Citation

Bayattork M, Seidi F, Minoonejad H, McClure P, Mozafaripoor E. Intra-rater and inter-rater reliability and agreement of the scapular dyskinesis test in young men with forward head and round shoulder posture. J Rehabil. Sci. 2019 Dec 10;6(4):169-173. https://doi.org/10.30476/JRSR.2019.82944.1037

Carter SE, Draijer R, Holder SM, Brown L, Thijssen DHJ, Hopkins ND. Regular walking breaks prevent the decline in cerebral blood flow associated with prolonged sitting. J Appl Physiol (1985). 2018 Sep 1;125(3):790-798. doi: 10.1152/japplphysiol.00310.2018. Epub 2018 Jun 7. — View Citation

Cuéllar JM, Lanman TH. "Text neck": an epidemic of the modern era of cell phones? Spine J. 2017 Jun;17(6):901-902. doi: 10.1016/j.spinee.2017.03.009. Epub 2017 Mar 20. — View Citation

Engelmann C, Schneider M, Kirschbaum C, Grote G, Dingemann J, Schoof S, Ure BM. Effects of intraoperative breaks on mental and somatic operator fatigue: a randomized clinical trial. Surg Endosc. 2011 Apr;25(4):1245-50. doi: 10.1007/s00464-010-1350-1. Epub 2010 Sep 11. — View Citation

Fahmy R. NASM Essentials of corrective exercise training. 2nd ed. Burlington, Massachusetts: Jones & Bartlett Learning; 2022.

Gustafsson E. Ergonomic recommendations when texting on mobile phones. Work. 2012;41 Suppl 1:5705-6. doi: 10.3233/WOR-2012-0925-5705. — View Citation

Hansraj KK. Assessment of stresses in the cervical spine caused by posture and position of the head. Surg Technol Int. 2014 Nov;25:277-9. — View Citation

Kalichman L, Bulanov N, Friedman A. Effect of exams period on prevalence of Myofascial Trigger points and head posture in undergraduate students: Repeated measurements study. J Bodyw Mov Ther. 2017 Jan;21(1):11-18. doi: 10.1016/j.jbmt.2016.04.003. Epub 2016 Apr 7. — View Citation

Kar G, Hedge A. Effect of workstation configuration on musculoskeletal discomfort, productivity, postural risks, and perceived fatigue in a sit-stand-walk intervention for computer-based work. Appl Ergon. 2021 Jan;90:103211. doi: 10.1016/j.apergo.2020.103211. Epub 2020 Aug 17. — View Citation

Kim BB, Lee JH, Jeong HJ, Cynn HS. Effects of suboccipital release with craniocervical flexion exercise on craniocervical alignment and extrinsic cervical muscle activity in subjects with forward head posture. J Electromyogr Kinesiol. 2016 Oct;30:31-7. doi: 10.1016/j.jelekin.2016.05.007. Epub 2016 May 24. — View Citation

Kim SY, Koo SJ. Effect of duration of smartphone use on muscle fatigue and pain caused by forward head posture in adults. J Phys Ther Sci. 2016 Jun;28(6):1669-72. doi: 10.1589/jpts.28.1669. Epub 2016 Jun 28. — View Citation

Kuroda Y, Sato Y, Ishizaka Y, Yamakado M, Yamaguchi N. Exercise motivation, self-efficacy, and enjoyment as indicators of adult exercise behavior among the transtheoretical model stages. Glob Health Promot. 2012 Mar;19(1):14-22. doi: 10.1177/1757975911423073. Epub 2012 Feb 14. — View Citation

Lau KT, Cheung KY, Chan KB, Chan MH, Lo KY, Chiu TT. Relationships between sagittal postures of thoracic and cervical spine, presence of neck pain, neck pain severity and disability. Man Ther. 2010 Oct;15(5):457-62. doi: 10.1016/j.math.2010.03.009. — View Citation

Lee DY, Nam CW, Sung YB, Kim K, Lee HY. Changes in rounded shoulder posture and forward head posture according to exercise methods. J Phys Ther Sci. 2017 Oct;29(10):1824-1827. doi: 10.1589/jpts.29.1824. Epub 2017 Oct 21. — View Citation

Neupane S, Ali UI, Mathew A. Text neck syndrome-systematic review. Imp. J. Interdiscip. Res. 2017; 3(7): 141-148. http://www.onlinejournal.in

Richards KV, Beales DJ, Smith AJ, O'Sullivan PB, Straker LM. Neck Posture Clusters and Their Association With Biopsychosocial Factors and Neck Pain in Australian Adolescents. Phys Ther. 2016 Oct;96(10):1576-1587. Epub 2016 May 12. — View Citation

Ruivo RM, Pezarat-Correia P, Carita AI. Cervical and shoulder postural assessment of adolescents between 15 and 17 years old and association with upper quadrant pain. Braz J Phys Ther. 2014 Jul-Aug;18(4):364-71. Epub 2014 Jul 18. — View Citation

Sahu M, Sundari KG, David A. Recent ergonomic interventions and evaluations on laptop, smartphones and desktop computer users. In Arockiarajan A, Duraiselvam M, Raju R, editors. Advances in Industrial Automation and Smart Manufacturing. Singapore: Springer; 2021. p. 207-224. https://doi.org/10.1007/978-981-15-4739-3

Syamala KR, Ailneni RC, Kim JH, Hwang J. Armrests and back support reduced biomechanical loading in the neck and upper extremities during mobile phone use. Appl Ergon. 2018 Nov;73:48-54. doi: 10.1016/j.apergo.2018.06.003. Epub 2018 Jun 18. — View Citation

Vate-U-Lan P. Text neck epidemic: a growing problem for smart phone users in Thailand. Int J Comput. Internet Manage. 2015 Sept-Dec;23(3): 551-556.

Warburton DER, Jamnik VK, Bredin SSD, and Gledhill N. The physical activity readiness questionnaire for everyone (PAR-Q+) and electronic physical activity readiness medical examination (ePARmed-X+). Health Fit J of Canada. 2011; 4(2):3-23. https://doi.org/10.14288/hfjc.v4i2.103

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Craniovertebral Angle after 4 weeks The angle between the intersection of two lines drawn on the photograph: the first line drawn from the tragus of the ear to the spinous process of C7 vertebrae and the second line drawn horizontally through C7 spinous process. In this study, a second researcher directly observed the primary investigator performing each CVA assessment, as well as provided verbal agreement with the accuracy of angle measurement. For each participant, the CVA was derived by taking the mean of two CVA measurements that were assessed on the captured photographs. Baseline: On day 1 of study enrollment; Post-Intervention: Within 5 days after the end of the 4 week intervention period
Secondary Midpoint Intervention Compliance On a questionnaire, participants were asked to rate their compliance with their assigned intervention guidelines. Consistent. 75% adherence to guidelines; Moderately Consistent. 50 to 75% adherence to guidelines; Inconsistent. Less than 50% adherence to guidelines. Assessed at the start of week 3
Secondary Endpoint Intervention Compliance On a questionnaire, participants were asked to rate their compliance with their assigned intervention guidelines. Consistent. 75% adherence to guidelines; Moderately Consistent. 50 to 75% adherence to guidelines; Inconsistent. Less than 50% adherence to guidelines. Within 5 days after the end of the 4 week intervention period.
See also
  Status Clinical Trial Phase
Completed NCT05293847 - Postural Based Telerehabilitation in Mechanic Neck Pain N/A
Completed NCT04686123 - Efficacy of a Supervised Intervention Protocol on Rounded Shoulder Posture and Shoulder ROM Among Saudi Young Females N/A
Completed NCT05173129 - Posture Analysis for Patients With Haemophilia N/A
Completed NCT05599204 - Effect Of Schroth Method On Balance In Upper Crossed Syndrome N/A
Completed NCT05591729 - Effect of Pilates on Balance and Spinal Curvature In Upper Crossed Syndrome N/A
Completed NCT05474443 - Comparison of Instrument Assisted Soft Tissue Mobilization and Myofascial Gun in Upper Cross Syndrome N/A
Completed NCT05710939 - Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients N/A
Recruiting NCT06278623 - Focal Muscle Vibration in Parkinson's Disease
Not yet recruiting NCT06298994 - Determination of Body Awareness and the Functional Movement in Patients With COPD
Not yet recruiting NCT06306482 - Determination of Posture in Patients With Restrictive and Obstructive Lung Disease
Completed NCT04256031 - Effects of Smartphone Use on Posture, Pain, Function and QoL
Not yet recruiting NCT06297798 - Effects of Telerehabilitation-Based Interventions on the Musculoskeletal System in Drivers N/A
Recruiting NCT05746702 - Investigation of Arm Swings Characteristics in Patient With Chronic Obstructive Pulmonary Disease
Completed NCT04343599 - Hypopressive Effectiveness in Postural Control and Pelvic Floor. N/A
Completed NCT05021068 - Spinal Structure and Mobility in Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT04317131 - Body Posture and the Stomatognathic System of School-age Children
Completed NCT03191552 - The Effect of Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Cerebral Palsy N/A
Recruiting NCT04911738 - VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical N/A
Recruiting NCT05911867 - Muscle Energy Technique and Mulligan's Mobilization in Breast Cancer Surgery Patients N/A
Not yet recruiting NCT03532984 - Beam Walking Across the Lifespan for Falls Prediction