NCT05865951

Brief Summary

Study will be a Randomized clinical trial to check the effects of isometric and isotonic strength training exercises on patients with chronic neck pain. The data will be collected in a hospital setting where patients of chronic mechanical neck pain will be screened out for the fulfillment of eligibility criteria of this study. After being eligible for this study their baseline outcome measures will be measured using Numeric pain rating scale, neck disability index, goniometer, dynamometer and short form 36 survey. Then they will be divided into two groups namely group A receiving isometric exercises with conventional treatment and group B receiving isotonic exercises with conventional treatment. Here conventional treatment includes thermotherapy, manual mobilisation of cervical and thoracic and trigger point therapy which will be a common treatment for both groups. The outcome measures will be measured later at 4th,8th and 12th week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

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 19, 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

April 18, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Numeric Pain Rating Scale (NPRS):

    It is a unidimensional outcome measure that is used for measuring intensity of chronic pain. It is a verbally administered scale rating from 0 to 10 where 10 quantifies worse pain intensity and 5 as a moderate intensity. The simplicity in pain scoring makes it a reliable scale with reliability 0.96 in literate and 0.95 in illiterate patients whereas validity ranges from 0.86 to 0.95.

    up to 12 weeks

  • Universal GONIOMETER for Range of Motion

    It is the device used for measuring range of motion of joints. One of the type of goniometer to be used in this study is universal goniometer with two arms, one arm is maintained at neutral position whereby the other arm moves with the moving part of body. The inter-observer reliability remains at 0.99 whereas validity being 0.97

    up to 12 weeks

  • Hand-Held DYNAMOMETER for muscle strength measurement

    Dynamometer is a hand-held device used to measure thestrength of muscles. It is to be placed as a resistance in the movement to quantify the muscle strength into force unit. It has reliability from 0.94 to 0.97.

    up to 12 weeks

  • NECK DISABILITY INDEX (NDI):

    It is a function specific questionnaire designed to measure thelevel of disability and restriction in activities of daily living. It comprises of 10 questions about daily living while the score is converted to percentage where 0% indicates no limitation in function while 50-100% indicates complete activity limitation. It has moderate test re-test reliability where ICC varies between 0.50 and 0.98, while it constructs a good validity.

    up to 12 weeks

Secondary Outcomes (1)

  • 36-Item Short Form Survey (SF-36) for quality of life

    up to 12 weeks

Study Arms (2)

chronic neck pain and isometric exercises group:

EXPERIMENTAL

Group A performed exercises for 12 weeks. Participants performed isometric exercises along with conventional physical therapy treatment ( thermotherapy, manual mobilisation of cervical spine and trigger point therapy). All exercises were performed for 3 sessions per week for a period of 12 weeks.

Other: Isometric Exercises

chronic neck pain and isotonic group

ACTIVE COMPARATOR

Group B performed exercises for 12 weeks. Participants performed isotonic exercises along with conventional physical therapy treatment ( thermotherapy, manual mobilisation of cervical spine and trigger point therapy). All exercises were performed for 3 sessions per week for a period of 12 weeks.

Other: Isotonic Exercises

Interventions

Isometric (same length) strengthening exercises of the neck muscles will be performed.

chronic neck pain and isometric exercises group:

Isotonic strengthening exercises for the neck muscles will be performed.

chronic neck pain and isotonic group

Eligibility Criteria

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

You may qualify if:

  • No discrimination against gender
  • Age group 25-55 years
  • Complain of chronic mechanical neck pain for more than 3 months

You may not qualify if:

  • Spinal cord injury
  • Malignancy
  • Cervical fracture
  • Any bony or soft tissue systemic disease
  • Ankylosis spondylitis
  • Craniovertebral disorders
  • Any cervical deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noor Fatima Hospital

Dinga, Punjab Province, 54700, Pakistan

Location

Related Publications (10)

  • Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.

    PMID: 28602744BACKGROUND
  • Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1.

    PMID: 18758050BACKGROUND
  • Berg HE, Berggren G, Tesch PA. Dynamic neck strength training effect on pain and function. Arch Phys Med Rehabil. 1994 Jun;75(6):661-5. doi: 10.1016/0003-9993(94)90189-9.

    PMID: 8002765BACKGROUND
  • Hrysomallis C. Neck Muscular Strength, Training, Performance and Sport Injury Risk: A Review. Sports Med. 2016 Aug;46(8):1111-24. doi: 10.1007/s40279-016-0490-4.

    PMID: 26861960BACKGROUND
  • Lin IH, Chang KH, Liou TH, Tsou CM, Huang YC. Progressive shoulder-neck exercise on cervical muscle functions in middle-aged and senior patients with chronic neck pain. Eur J Phys Rehabil Med. 2018 Feb;54(1):13-21. doi: 10.23736/S1973-9087.17.04658-5. Epub 2017 Jul 17.

    PMID: 28714658BACKGROUND
  • Conley MS, Stone MH, Nimmons M, Dudley GA. Specificity of resistance training responses in neck muscle size and strength. Eur J Appl Physiol Occup Physiol. 1997;75(5):443-8. doi: 10.1007/s004210050186.

    PMID: 9189733BACKGROUND
  • Salo PK, Hakkinen AH, Kautiainen H, Ylinen JJ. Effect of neck strength training on health-related quality of life in females with chronic neck pain: a randomized controlled 1-year follow-up study. Health Qual Life Outcomes. 2010 May 14;8:48. doi: 10.1186/1477-7525-8-48.

    PMID: 20465854BACKGROUND
  • Hakkinen A, Kautiainen H, Hannonen P, Ylinen J. Strength training and stretching versus stretching only in the treatment of patients with chronic neck pain: a randomized one-year follow-up study. Clin Rehabil. 2008 Jul;22(7):592-600. doi: 10.1177/0269215507087486.

    PMID: 18586810BACKGROUND
  • Gallego-Sendarrubias GM, Rodriguez-Sanz D, Calvo-Lobo C, Martin JL. Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Acupunct Med. 2020 Aug;38(4):244-254. doi: 10.1136/acupmed-2018-011682. Epub 2020 Mar 23.

    PMID: 32202124BACKGROUND
  • Amjad M, Ur Rehman SS, Fatima G, Ikram M, Ghafoor S. Comparative effects of isometric and isotonic global neck muscles strengthening exercise programme on pain, range of motion, strength, function and quality of life in patients with chronic mechanical neck pain. J Pak Med Assoc. 2024 Oct;74(10):1843-1846. doi: 10.47391/JPMA.11378.

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Misha Butt, 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

April 18, 2023

First Posted

May 19, 2023

Study Start

April 15, 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