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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05865223
Other study ID # REC/RCR&AHS/23/0018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2023
Est. completion date August 30, 2023

Study information

Verified date September 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study will be a Randomized clinical trial to check comparison of mckenzie exercise program versus routine physical therapy management on pain, range of motion and function in patients with chronic neck pain so that we can devise a treatment protocol.Total fifty subjects will be included in this study .Out of total 25 will be randomly allocated via lottery method in group 1 and 25 will be allocated in group 2. Group 1 will receive mckenzie exercise program and routine physical therapy(Joint mobilization, hot pack for 15 minutes and home exercise program) while Group 2 will receive only routine physical therapy (Joint mobilization , hot pack for 15 min and home exercise program). All patients will be treated for 12 sessions, two sessions per week for 6 weeks. Neck pain and disability index consist of two parts, part one which assesses pain severity and part two which assesses functional disability. Study setting will be services hospital. Assesment will be done at 0 week, 4week, 8week and 12weeks. Data was analysed by using SPSS version 26.


Description:

Neck pain is a key public health issue that affects the human beings with reduction productivity and quality of life and produced significant socioeconomic burden on society.The purpose of this study to determine the effectiveness of Mckenzie exercise program and routine physical therapy management on pain range of motion and function in patient with chronic mechanical neck pain. Patients of both gender, neck pain for at least 3 months and age 25-55 years will be included. Patients having history of trauma, vertebral fracture, congenital disorder, ankylosing spondylitis, tumour, pott's disease and any bony or soft tissue systematic disease will be excluded. The main objective of this study is to evaluate pain level and effect of Mackenzie protocol for individuals suffering from chronic neck pain. The tools used will be Neck disability index score (NDI), Numeric Pain Rating Scale (NPRS) and Goniometer for outcome measure pain, range of motion and function. Study will be conducted into 2 groups, each group will have 12 patients and comparisons of two groups will be evaluated. One group will receive Mckenzie exercise program and Routine physical therapy (Joint Mobilization, Hot pack and home exercise program) for 12 weeks and 2 days a week for 40 min each session and other group will receive Routine physical therapy (Joint mobilization, Hot pack and home exercise plan) for 12 weeks and 2 days a week for 30 min each session. Assessment will be done at 0 weeks, 4 week, 8 week and 12 week.Both groups received hot packs for 15 minutes for warming up.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 30, 2023
Est. primary completion date August 20, 2023
Accepts healthy volunteers No
Gender All
Age group 25 Years to 55 Years
Eligibility Inclusion Criteria: - Both Gender - Neck pain for at least 3 months - Age 25-55 years old Exclusion Criteria: - • History of trauma - Vertebral Fracture - Congenital disorder - Ankylosing spondylitis - Tumour - Pott's Spine - Any bony or soft tissue systemic disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mckenzie exercise program
MacKenzie extension exercise program for cervical spine
Conventional Physical therapy
hot pack for 15 minutes will be given followed by joint mobilization,and home exercise program.

Locations

Country Name City State
Pakistan Services Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Abdel-Aziem AA, Mohamed RR, Draz AH, Azab AR, Hegazy FA, Diab RH. The effect of McKenzie protocol vs. deep neck flexor and scapulothoracic exercises in subjects with chronic neck pain - a randomized controlled study. Eur Rev Med Pharmacol Sci. 2022 May;26(9):3138-3150. doi: 10.26355/eurrev_202205_28731. — View Citation

Farooq MN, Mohseni-Bandpei MA, Gilani SA, Ashfaq M, Mahmood Q. The effects of neck mobilization in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2018 Jan;22(1):24-31. doi: 10.1016/j.jbmt.2017.03.007. Epub 2017 Mar 4. — View Citation

Guez M, Hildingsson C, Nilsson M, Toolanen G. The prevalence of neck pain: a population-based study from northern Sweden. Acta Orthop Scand. 2002 Aug;73(4):455-9. doi: 10.1080/00016470216329. — View Citation

Kjellman G, Oberg B. A randomized clinical trial comparing general exercise, McKenzie treatment and a control group in patients with neck pain. J Rehabil Med. 2002 Jul;34(4):183-90. doi: 10.1080/16501970213233. — View Citation

Letafatkar A, Rabiei P, Alamooti G, Bertozzi L, Farivar N, Afshari M. Effect of therapeutic exercise routine on pain, disability, posture, and health status in dentists with chronic neck pain: a randomized controlled trial. Int Arch Occup Environ Health. 2020 Apr;93(3):281-290. doi: 10.1007/s00420-019-01480-x. Epub 2019 Oct 25. — View Citation

Swenson RS. Therapeutic modalities in the management of nonspecific neck pain. Phys Med Rehabil Clin N Am. 2003 Aug;14(3):605-27. doi: 10.1016/s1047-9651(03)00038-x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical Rating Scale (NRS) Patients are asked to circle the number on a Numerical Rating Scale (NRS) that best describes their level of discomfort between 0 and 10, 0 and 20, or 0 and 100. The lower limit often denotes "the least amount of suffering ," whereas zero typically denotes "no pain at all." up to 12 weeks
Primary Universal Goniometer for range of motion measurement The most popular and reliable approach for determining shoulder range of motion (ROM) is by utilizing a goniometer. A goniometer is a straightforward instrument that has two arms joined at a hinge. The goniometer's second arm would be used to measure the joint angle while the physiotherapist placed one arm of the patient against the patient's body up to 12 weeks
Primary Neck disability index (NDI) The Neck Disability Index (modification of the oswestry low back pain disability index) scale scores range from 0 to 5 and the total score is the sum of the item scores possible range 0 no pain to 100 maximal pain up to 12 weeks
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