- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05261698
Effects of Home-Based Exercise Manual on Pain and Disability in Patients of Postural Neck Pain
Effects of Routine Physical Therapy With and Without Home-Based Exercise Manual on Pain and Disability in Patients of Postural Neck Pain: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After back pain, most commonly found musculoskeletal ailment is the neck pain. Due to the poor neck posture, postural neck pain appears. It is estimated that, about 60% of the neck pain patients' have the forward head posture. Many people visit hospitals or other medical centers at least once in their life due to this problem.
Those individuals with chronic neck pain who work in offices, industries or perform other computer-based tasks, that require sitting for longer period of time have altered postural behaviors. Persistent neck pain has the negative impact as it has the potential to change the biomechanics of cervical spine specifically in individuals who spend most of their time in sitting position in front of computer screens. Continuous postural neck pain may lead to the forward head posture that rises load on the posterior structures of the cervical spine such as ligaments, muscles, bones and joint capsules and brings changes in scapular kinetics and kinematics.
According to the previous researches, forward head posture causes tightening of the shoulder and anterior neck muscles, shortening of the posterior neck extensors, and affects the kinematics and position of the scapula. Proper posture of the body is believed to be the state in which there is a musculoskeletal balance and minimal amount of strain and stress on the body. However most of the people are not able to maintain that equilibrium in the musculoskeletal structures of the body.
An ideal posture is considered only when the external auditory meatus is lined up with the vertical postural line. As seen in in the lateral view, the vertical line passes through external auditory meatus, the shoulder joint, slightly behind the hip joint, through the center of the knee joint and slightly in front of the ankle joint. Postural neck pain is believed to be associated with the forward head posture and is one of the common types of poor head posture seen in patients with neck disorders.
Neck pain is the most commonly occurring clinical condition, and its associated social and economic costs related to disability and days off work are just about equal to the lumbar pain. Individuals with the postural neck pain have been reported with the change in muscular control such as increased activity of the superficial muscles of the cervical spine and upper trapezius. Although the exact association between posture and neck pain is unresolved. Cervical neck posture is believed to have impact on dorsal neck muscle activity during lifting or even at rest. Moreover, postural neck pain may lead to the forward head posture linked with the thoracic kyphosis which has indirect impact on the rotational range of motion and cervical flexion. Occupations with sustained computer use and prolong computer usage may lead to the functional kyphosis, that seems to affect posture of the neck and scapular positioning and activity of the upper trapezius. Modifications in the workplace environment and postural correction have been shown in reducing postural neck pain.
The main aim of the study is to compare the effects of routine physical therapy with and without home-based exercise manual on pain and disability in patients of postural neck pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54770
- Pakistan Society for Rehabilitation of the Disabled
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients with postural neck pain aged 18-60 years shall be included.
- Patients experiencing postural neck pain at least once a week.
- A symptom duration of greater than 3 months.
- Postural neck pain that is aggravated by the sustained postural loading, and relieved by postural modification.
- Patients who are able to read and write.
Exclusion Criteria:
- Neck pain due to specific causes i.e. disc protrusion, radicular syndrome
- Any accidental injury of spine
- Inflammatory rheumatic disease
- Congenital deformity of the spine
- Spinal canal stenosis
- Neoplasm
- Females who are pregnant
- Patients who had spinal surgery within the previous 12 months or any other invasive treatment of the spine within the previous 4 weeks.
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 |
|---|---|
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Active Comparator: Arms
Control group: in control group moist heating pads along with TENS shall be applied on neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed.
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In this group patients will receive routine physical therapy including hot pack for 10 minutes, stretching, strengthening exercise and TENS at the end of each session.
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Experimental: Assigned Interventions
Experimental group: in the experimental group we will provide moist heating pads along with TENS on the neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed.
Patients in the experimental group will also receive a home-based exercise manual.
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in the experimental group we will provide moist heating pads along with TENS on the neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed.
Patients in the experimental group will also receive a home-based exercise manual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numerical Pain Rating Scale (NPRS)
Time Frame: 2 weeks
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Pain will be measured by Numerical Pain Rating Scale (NPRS), in which patients are asked to circle the number between 0 and 10.
The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
The patient picks (verbal version) or draws a circle around.
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2 weeks
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Neck Disability Index (NDI)
Time Frame: 2 weeks
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The Neck Disability Index (NDI) is a self-report questionnaire which is used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain.
This questionnaire is used to gather the details about the intensity of neck pain among patients that has affected the capability to manage in daily routine.
Every single section of this questionnaire is scored on a 0 to 5 rating scale, in which 0 means "no pain" whereas 5 means "worst imaginable pain".
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2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Adil, MPHIL-MSK*, University of Lahore
Publications and helpful links
General Publications
- Im B, Kim Y, Chung Y, Hwang S. Effects of scapular stabilization exercise on neck posture and muscle activation in individuals with neck pain and forward head posture. J Phys Ther Sci. 2016 Mar;28(3):951-5. doi: 10.1589/jpts.28.951. Epub 2016 Mar 31.
- Gupta BD, Aggarwal S, Gupta B, Gupta M, Gupta N. Effect of Deep Cervical Flexor Training vs. Conventional Isometric Training on Forward Head Posture, Pain, Neck Disability Index In Dentists Suffering from Chronic Neck Pain. J Clin Diagn Res. 2013 Oct;7(10):2261-4. doi: 10.7860/JCDR/2013/6072.3487. Epub 2013 Oct 5.
- Mani S, Sharma S, Singh DK. Concurrent validity and reliability of telerehabilitation-based physiotherapy assessment of cervical spine in adults with non-specific neck pain. J Telemed Telecare. 2021 Feb;27(2):88-97. doi: 10.1177/1357633X19861802. Epub 2019 Jul 4.
- Wegner S, Jull G, O'Leary S, Johnston V. The effect of a scapular postural correction strategy on trapezius activity in patients with neck pain. Man Ther. 2010 Dec;15(6):562-6. doi: 10.1016/j.math.2010.06.006. Epub 2010 Jul 21.
- Pillastrini P, de Lima E Sa Resende F, Banchelli F, Burioli A, Di Ciaccio E, Guccione AA, Villafane JH, Vanti C. Effectiveness of Global Postural Re-education in Patients With Chronic Nonspecific Neck Pain: Randomized Controlled Trial. Phys Ther. 2016 Sep;96(9):1408-16. doi: 10.2522/ptj.20150501. Epub 2016 Mar 24.
- Argent R, Daly A, Caulfield B. Patient Involvement With Home-Based Exercise Programs: Can Connected Health Interventions Influence Adherence? JMIR Mhealth Uhealth. 2018 Mar 1;6(3):e47. doi: 10.2196/mhealth.8518.
- Cramer H, Lauche R, Hohmann C, Ludtke R, Haller H, Michalsen A, Langhorst J, Dobos G. Randomized-controlled trial comparing yoga and home-based exercise for chronic neck pain. Clin J Pain. 2013 Mar;29(3):216-23. doi: 10.1097/AJP.0b013e318251026c.
- Fakhry F, Spronk S, de Ridder M, den Hoed PT, Hunink MG. Long-term effects of structured home-based exercise program on functional capacity and quality of life in patients with intermittent claudication. Arch Phys Med Rehabil. 2011 Jul;92(7):1066-73. doi: 10.1016/j.apmr.2011.02.007.
- Baggetta R, D'Arrigo G, Torino C, ElHafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G; EXCITE Working group. Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial. BMC Geriatr. 2018 Oct 20;18(1):248. doi: 10.1186/s12877-018-0938-5.
- Damasceno GM, Ferreira AS, Nogueira LAC, Reis FJJ, Andrade ICS, Meziat-Filho N. Text neck and neck pain in 18-21-year-old young adults. Eur Spine J. 2018 Jun;27(6):1249-1254. doi: 10.1007/s00586-017-5444-5. Epub 2018 Jan 6.
- Korakakis V, O'Sullivan K, O'Sullivan PB, Evagelinou V, Sotiralis Y, Sideris A, Sakellariou K, Karanasios S, Giakas G. Physiotherapist perceptions of optimal sitting and standing posture. Musculoskelet Sci Pract. 2019 Feb;39:24-31. doi: 10.1016/j.msksp.2018.11.004. Epub 2018 Nov 17.
- Edmondston S, Bjornsdottir G, Palsson T, Solgard H, Ussing K, Allison G. Endurance and fatigue characteristics of the neck flexor and extensor muscles during isometric tests in patients with postural neck pain. Man Ther. 2011 Aug;16(4):332-8. doi: 10.1016/j.math.2010.12.005. Epub 2011 Jan 20.
- Nasir MF, Jawed R, Baig NN, Younus M, Arshad A, Tahir A. A study to observe the effects of physiotherapy with and without manual therapy in the management postural neck pain: A randomized control trial. J Pak Med Assoc. 2021 Jan;71(1(A)):8-11. doi: 10.47391/JPMA.186.
- 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. doi: 10.2522/ptj.20150660. Epub 2016 May 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULahore Muhammad Adil
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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