Clinical trial NCT05865223: Comparison Of Mackenzie Exercise Program Versus Routine Physical Therapy Management in Chronic Mechanical Neck Pain
Official title: Title Comparison Of Mackenzie Exercise Program Versus Routine Physical Therapy Management On Pain , Range Of Motion And Function in Patient With Chronic Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: up to 12 weeks
measure: Universal Goniometer for range of motion measurement
timeFrame: up to 12 weeks
measure: Neck disability index (NDI)
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Zanam Nasir, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.