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Comparison of Isometric and Isotonic Strengthening Exercises in Chronic Neck Pain Patients.

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Isometric Exercises
Isotonic Exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: No discrimination against gender Age group 25-55 years Complain of chronic mechanical neck pain for more than 3 months Exclusion Criteria: Spinal cord injury Malignancy Cervical fracture Any bony or soft tissue systemic disease Ankylosis spondylitis Craniovertebral disorders Any cervical deformity

Sites / Locations

  • Noor Fatima HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

chronic neck pain and isometric exercises group:

chronic neck pain and isotonic group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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.
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.

Secondary Outcome Measures

36-Item Short Form Survey (SF-36) for quality of life
This survey quantifies the quality of life. It comprises of 36questions related to health, physical activity and psychology. It has shown to be reliable and a valid questionnaire.Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high quality of life.SF-36 scores range from 0 (worst) to 100 (best).

Full Information

First Posted
April 18, 2023
Last Updated
June 6, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05865951
Brief Title
Comparison of Isometric and Isotonic Strengthening Exercises in Chronic Neck Pain Patients.
Official Title
Long-term Comparative Effects of Isometric and Isotonic Global Neck Muscles Strengthening Exercise Program on Pain, Range of Motion, Strength, Function, and Quality of Life in Patients With Chronic Mechanical Neck Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Chronic neck pain is a burden to health globally and is the major reason behind years of disability. This is due to the higher prevalence, persistence and recurrence.It is a frequent reason for visit to physical therapist or a physician. It is the major health concern for society these days with highest recurrence rate combined with its chronicity. The overall worldwide prevalence for it is 16.7% to 75.1%. There is scarce knowledge of use of isotonic neck muscles strengthening in clinical trials. Moreover the literature has not satisfied the long term effects of isometric and isotonic strength training exercises of cervical muscles on improving the health related quality of life and restoring the normal function of cervical spine. The findings of current study will help to establish long term effects of isometric and isotonic strengthening exercises on pain, strength, function and quality of life in chronic mechanical neck pain patients. Neck strength training exercises have shown to reduce neck muscle injuries in sports.Neck strength training has also proved beneficial in reducing neck pain as part of training. The static muscle contractions of neck muscles of patient being seated with the resistance of palm of physiotherapist being standing will be performed in six cervical movements i.e. flexion, extension, right lateralflexion, left lateral flexion, right rotation, left rotation. The dynamic muscle contractions of neck muscles will be performed using thera-band for resistance tied on the wall for all six movements of cervical spine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chronic neck pain and isometric exercises group:
Arm Type
Experimental
Arm Description
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.
Arm Title
chronic neck pain and isotonic group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Isometric Exercises
Intervention Description
Isometric (same length) strengthening exercises of the neck muscles will be performed.
Intervention Type
Other
Intervention Name(s)
Isotonic Exercises
Intervention Description
Isotonic strengthening exercises for the neck muscles will be performed.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS):
Description
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.
Time Frame
up to 12 weeks
Title
Universal GONIOMETER for Range of Motion
Description
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
Time Frame
up to 12 weeks
Title
Hand-Held DYNAMOMETER for muscle strength measurement
Description
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.
Time Frame
up to 12 weeks
Title
NECK DISABILITY INDEX (NDI):
Description
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.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
36-Item Short Form Survey (SF-36) for quality of life
Description
This survey quantifies the quality of life. It comprises of 36questions related to health, physical activity and psychology. It has shown to be reliable and a valid questionnaire.Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high quality of life.SF-36 scores range from 0 (worst) to 100 (best).
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: No discrimination against gender Age group 25-55 years Complain of chronic mechanical neck pain for more than 3 months Exclusion Criteria: Spinal cord injury Malignancy Cervical fracture Any bony or soft tissue systemic disease Ankylosis spondylitis Craniovertebral disorders Any cervical deformity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misha Butt, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noor Fatima Hospital
City
Dinga
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28602744
Citation
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Results Reference
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PubMed Identifier
18758050
Citation
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. Erratum In: J Orthop Sports Phys Ther. 2009 Apr;39(4):297.
Results Reference
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PubMed Identifier
8002765
Citation
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.
Results Reference
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PubMed Identifier
26861960
Citation
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.
Results Reference
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PubMed Identifier
28714658
Citation
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.
Results Reference
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PubMed Identifier
9189733
Citation
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.
Results Reference
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PubMed Identifier
20465854
Citation
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.
Results Reference
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PubMed Identifier
18586810
Citation
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.
Results Reference
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PubMed Identifier
32202124
Citation
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.
Results Reference
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Comparison of Isometric and Isotonic Strengthening Exercises in Chronic Neck Pain Patients.

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