NCT05856006

Brief Summary

A Randomized controlled trial will be conducted. Non-probability convnience sampling will be used to collect the data. Sample size of 42 subjects with age group between 18 to 40 years will be taken. Data will be collected by using tools Numeric Pain Rate Scale (NPRS) for pain, Neck Disability Index (NDI) for disability and SF-36 for Quality of life. An informed consent will be taken. A total of 20 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both groups will come thrice per week for a total of 4 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 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 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

May 4, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rate Scale (NPRS)

    Patient level of pain will be assessed using this scale. This scale ranges from 0to10."0"indicates "no pain" and "10" indicates "worst pain".

    up to 4 weeks

  • Neck Disability Index

    NDI is a 10-item questionnaire that measures a patient's self-reported neck pain related disability

    up to 4 weeks

  • SF-36 for Quality of life

    The SF-36 is a 36-item scale constructed to survey health status and quality. The SF-36 assesses eight health concepts: limitations in Quality of lifephysical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The standard form of the instruments asks for participants to reply to questions according to how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 pointsmotions

    up to 4 weeks

Study Arms (2)

Stretching Group

ACTIVE COMPARATOR

upper trapezius stretching plus neck isometrics

Other: upper trapezius stretching plus neck isometrics

Stretching plus strengthening Group

EXPERIMENTAL

upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometrics

Other: upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometrics

Interventions

upper trapezius stretching plus neck isometrics

Stretching Group

Mid-Lower Trapezius strengthening exercise includes: 1. Latissimus pull down 2. Prone V- raise 3. Modified Prone Cobra

Stretching plus strengthening Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females between the age range of 18-40 years
  • Examination-Symptoms provoked by neck movement and palpation of Trapezius musculature.
  • Positive Trapezius Strength Test

You may not qualify if:

  • Participants who present with dizziness and vertigo
  • Infection or febrile state at the time of performing the test;
  • Anxiety or extreme emotional tension;
  • pharmacological treatment (analgesics, muscle relaxants, anxiolytics, antidepressants)
  • Disc lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria International Hospital

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (8)

  • Wang YZ, Wang AN, Gao XS, Du Y, Li L, Zhao JJ. [Effect of the small needle knife through the Zusanli(ST 36) on behavior and hippocampal expression of NLRP3 and IL-1beta in myalgia comorbid depressed rats]. Zhongguo Gu Shang. 2019 Dec 25;32(12):1151-1155. doi: 10.3969/j.issn.1003-0034.2019.12.017. Chinese.

    PMID: 31870077BACKGROUND
  • Kamper SJ, Henschke N, Hestbaek L, Dunn KM, Williams CM. Musculoskeletal pain in children and adolescents. Braz J Phys Ther. 2016 Feb 16;20(3):275-84. doi: 10.1590/bjpt-rbf.2014.0149.

    PMID: 27437719BACKGROUND
  • Lee KW, Kim WH. Effect of thoracic manipulation and deep craniocervical flexor training on pain, mobility, strength, and disability of the neck of patients with chronic nonspecific neck pain: a randomized clinical trial. J Phys Ther Sci. 2016 Jan;28(1):175-80. doi: 10.1589/jpts.28.175. Epub 2016 Jan 30.

    PMID: 26957752BACKGROUND
  • Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.

    PMID: 34900443BACKGROUND
  • Cote P, Cassidy JD, Carroll L. The Saskatchewan Health and Back Pain Survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine (Phila Pa 1976). 1998 Aug 1;23(15):1689-98. doi: 10.1097/00007632-199808010-00015.

    PMID: 9704377BACKGROUND
  • Suvarnnato T, Puntumetakul R, Kaber D, Boucaut R, Boonphakob Y, Arayawichanon P, Chatchawan U. The effects of thoracic manipulation versus mobilization for chronic neck pain: a randomized controlled trial pilot study. J Phys Ther Sci. 2013 Jul;25(7):865-71. doi: 10.1589/jpts.25.865. Epub 2013 Aug 20.

    PMID: 24259872BACKGROUND
  • Chansirinukor W, Wilson D, Grimmer K, Dansie B. Effects of backpacks on students: measurement of cervical and shoulder posture. Aust J Physiother. 2001;47(2):110-6. doi: 10.1016/s0004-9514(14)60302-0.

    PMID: 11552866BACKGROUND
  • Lee KS, Lee JH. Effect of maitland mobilization in cervical and thoracic spine and therapeutic exercise on functional impairment in individuals with chronic neck pain. J Phys Ther Sci. 2017 Mar;29(3):531-535. doi: 10.1589/jpts.29.531. Epub 2017 Mar 22.

    PMID: 28356648BACKGROUND

Study Officials

  • Maryam Azam, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 12, 2023

Study Start

April 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 15, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations