NCT05865223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

April 18, 2023

Last Update Submit

September 15, 2023

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Mckenzie exercise program

EXPERIMENTAL

Group A Week 0 : Hot pack for 15 minutes, mackenzie extension exercise program for cervical regions and mobilization with movement at cervical regions for improving flexion, extension, side flexion and rotation. 3 sets of painless glides of 10 repetitions were given, with 1 minute rest between sets. * Week 2 \& 4: Hot pack for 15 minutes, mckenzie exercise program at cervical region with the progression in repetition and MWM at cervical regions and then we will add progression.5 sets of painless glides of 10 repetitions were given, with 3 minute rest between sets. * Week 3 \& 6: Hot pack for 15 minutes, mckenzie exercise program for cervical region and MWM at cervical region . 5 sets of painless glides for 10 repetitions were given. Progression can be introduced by increasing number of repetitions performed exercises for 3 weeks.

Other: Mckenzie exercise program

conventional physical therapy

ACTIVE COMPARATOR

A routine physical therapy(joint mobilization,hot pack and home exercise program) treatment and hot pack for 15 minutes.

Other: Conventional Physical therapy

Interventions

Mckenzie exercise programOTHER

MacKenzie extension exercise program for cervical spine

Mckenzie exercise program
Conventional Physical therapyOTHER

hot pack for 15 minutes will be given followed by joint mobilization,and home exercise program.

conventional physical therapy

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Gender
  • Neck pain for at least 3 months
  • Age 25-55 years old

You may not qualify if:

  • History of trauma
  • Vertebral Fracture
  • Congenital disorder
  • Ankylosing spondylitis
  • Tumour
  • Pott's Spine
  • Any bony or soft tissue systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital

Lahore, Punjab Province, 54700, Pakistan

Location

Related 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.

    PMID: 35587064BACKGROUND

  • 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.

    PMID: 12358121BACKGROUND

  • 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.

    PMID: 29332752BACKGROUND

  • 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.

    PMID: 31654125BACKGROUND

  • 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.

    PMID: 12948344BACKGROUND

  • 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.

    PMID: 12201614BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zanam Nasir, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 18, 2023

Study Start

April 15, 2023

Primary Completion

August 20, 2023

Study Completion

August 30, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)