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Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
baseline physical therapy treatment
Cervical Stabilization 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 focused on measuring NDI, NPRS, CVA, SBC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with chronic neck pain for more than 3 months.
  • Mild neck disability (NDI score 5-15)

Exclusion Criteria:

  • Neck pain secondary to trauma
  • Deformities of thoracic region or vertebral column
  • History of any thoracic or vertebral column surgery.
  • History of smoking
  • Patients with any other serious pathology/red flags

Sites / Locations

  • Jinnah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

baseline physical therapy treatment

Cervical Stabilization exercises

Arm Description

baseline physical therapy treatment ,Control group- Group A

baseline physical therapy treatment along with Cervical Stabilization exercises- Experimental Group- Group B

Outcomes

Primary Outcome Measures

Numeric Pain rating scale
The NPRS is the segmented numeric version of visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The common format is a horizontal bar or line. Similar to VAS, the NPRS is anchored by terms describing pain severity extremes.

Secondary Outcome Measures

Neck disability Index
Methods of assessment for such disability, especially those targeted at activities of daily living which are most affected by neck pain, questionnaire 10-item scaled entitled the Neck Disability Index (NDI)

Full Information

First Posted
December 16, 2020
Last Updated
March 4, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04674891
Brief Title
Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain
Official Title
Effects of Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain Patients With Forward Head Posture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
January 30, 2021 (Actual)

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
Yes

5. Study Description

Brief Summary
This project was a Randomized control trial conducted to check the effects of Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain Patients with Forward Head Posture, duration of study was of 6 months, convenient sampling was done, subject following eligibility criteria from Jinnah Hospital Lahore, were randomly allocated in two groups via lottery method, baseline assessment was done, Group A participants were given baseline treatment protocol for 4 weeks which included 3 sessions per week. Heating Pad applied for 15 min and TENS (Transcutaneous Electric Nerve Stimulation) for 10 min. After that Cervical isometric exercises performed in sitting (10sec hold, 10 to 15 reps). Group B was experimental group and participants were given baseline treatment in addition to Cervical Stabilization exercises for 4 weeks which included 3 sessions per week. The baseline measurement was taken on day one for Numeric Pain Rating Scale (NRPS) and Neck Disability Index (NDI). Forward head posture assessed by measuring Cranio Vertebral Angle (CVA). Respiratory muscle strengths measured by Spirometer and SBC (single breath count). All the measurements repeated at the end of fourth week. Data was analyzed by using SPSS version 20.
Detailed Description
Extensive usage of electronic gadgets in today's life leads to the musculoskeletal problems among which neck pain is the most common problem reported to physicians, orthopedics and physical therapists. Even before reporting to clinics there is long history of using over the counter pain killers. Pain avoidance behaviors let the cervical spine stiff so much that a clinician help is sought. There is huge literature regarding the management of chronic neck pain and yet after the decades of research there are gaps in treatment options. In modern age of health care, it is common goal of every healthcare to make patient self-sufficient as early as possible. The self-care models have tremendous advantages. The current study has compared the effects of cervical stabilization exercises and isometric exercises. The current study was novel in a way that there is limited literature about treating Chronic Neck Pain Patients with effects of physiotherapy on respiratory strength in improving forward head posture. All the methods were employed to see if they improve ranges along with accompanying pain and disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
NDI, NPRS, CVA, SBC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
baseline physical therapy treatment
Arm Type
Active Comparator
Arm Description
baseline physical therapy treatment ,Control group- Group A
Arm Title
Cervical Stabilization exercises
Arm Type
Experimental
Arm Description
baseline physical therapy treatment along with Cervical Stabilization exercises- Experimental Group- Group B
Intervention Type
Other
Intervention Name(s)
baseline physical therapy treatment
Intervention Description
Group A was control group and the patients received Conventional treatment protocol for 4 weeks which included 3 sessions per week. Patients received hot pack for 15 min and TENS (Transcutaneous Electric Nerve Stimulation) for 10 min. After that Cervical isometric exercises will be performed in sitting (10sec hold,10 to 15 reps)
Intervention Type
Other
Intervention Name(s)
Cervical Stabilization exercises
Intervention Description
Group B was experimental group and received baseline physiotherapy treatment in addition to Cervical Stabilization exercises. Pillow was placed beneath cervical spine in supine position and guided patients to nod head as though they said 'yes' and asked them to hold for 10 seconds. 10 repetitions were done before progressing to the next target level. 4 weeks (3 sessions per week) Hot pack: 10 min TENS: 10 min Cervical isometric exercises in sitting (10sec hold,10 to 15 reps) Cervical Stabilization exercises (10 sec hold, 10 reps) On eligible participants baseline assessment was taken on day 1, post intervention assessment was taken at the end of 4th week.
Primary Outcome Measure Information:
Title
Numeric Pain rating scale
Description
The NPRS is the segmented numeric version of visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The common format is a horizontal bar or line. Similar to VAS, the NPRS is anchored by terms describing pain severity extremes.
Time Frame
4th week
Secondary Outcome Measure Information:
Title
Neck disability Index
Description
Methods of assessment for such disability, especially those targeted at activities of daily living which are most affected by neck pain, questionnaire 10-item scaled entitled the Neck Disability Index (NDI)
Time Frame
4th Week
Other Pre-specified Outcome Measures:
Title
Spirometer
Description
A spirometer is an apparatus for measuring the volume of air inspired and expired by the lungs. A spirometer measures ventilation, the movement of air into and out of the lungs. The spirogram will identify two different types of abnormal ventilation patterns, obstructive and restrictive
Time Frame
4th Week
Title
Single Breath Count( SBC)
Description
To perform, ask patient to count out loud after maximal inspiration. Ability to reach 50 indicates normal respiratory function. Single breath count of less than 15 typically correlates with low forced vital capacity (FVC) and respiratory muscle weakness
Time Frame
4th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with chronic neck pain for more than 3 months. Mild neck disability (NDI score 5-15) Exclusion Criteria: Neck pain secondary to trauma Deformities of thoracic region or vertebral column History of any thoracic or vertebral column surgery. History of smoking Patients with any other serious pathology/red flags
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil Ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31771837
Citation
Miranda IF, Wagner Neto ES, Dhein W, Brodt GA, Loss JF. Individuals With Chronic Neck Pain Have Lower Neck Strength Than Healthy Controls: A Systematic Review With Meta-Analysis. J Manipulative Physiol Ther. 2019 Oct;42(8):608-622. doi: 10.1016/j.jmpt.2018.12.008. Epub 2019 Nov 23.
Results Reference
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Citation
Migliarese S, White E. Review of Forward-Head Posture and Vestibular Deficits in Older Adults. Current Geriatrics Reports. 2019;8(3):194-201.
Results Reference
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Citation
Gurudut P, Welling A, Chodankar A. Effect of self-care exercises in forward head posture on craniovertebral angle and craniocervical flexion endurance: A pilot study. Indian Journal of Physical Therapy and Research. 2020;2(1):25.
Results Reference
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Citation
Son K-k, Cynn H-S, Lee J-H, Park D-H, Kim B-B. Effects of Deep Cervical Flexor Exercise with Visual Guide on Muscle Activity and Craniovertebral Angle in Subjects with Forward Head Posture. Korean Society of Physical Medicine. 2019;14(2):53-61.
Results Reference
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PubMed Identifier
30774207
Citation
Koseki T, Kakizaki F, Hayashi S, Nishida N, Itoh M. Effect of forward head posture on thoracic shape and respiratory function. J Phys Ther Sci. 2019 Jan;31(1):63-68. doi: 10.1589/jpts.31.63. Epub 2019 Jan 10.
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Mathur H, Khan SA, Siddiqui ZA. Effect of forward head posture on swallowing: Review of Literature. 2019
Results Reference
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PubMed Identifier
31985500
Citation
Herman PM, Vernon H, Hurwitz EL, Shekelle PG, Whitley MD, Coulter ID. Clinical Scenarios for Which Cervical Mobilization and Manipulation Are Considered by an Expert Panel to Be Appropriate (and Inappropriate) for Patients With Chronic Neck Pain. Clin J Pain. 2020 Apr;36(4):273-280. doi: 10.1097/AJP.0000000000000800.
Results Reference
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PubMed Identifier
31809920
Citation
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Results Reference
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PubMed Identifier
30896250
Citation
Storto CJ, Garcez AS, Suzuki H, Cusmanich KG, Elkenawy I, Moon W, Suzuki SS. Assessment of respiratory muscle strength and airflow before and after microimplant-assisted rapid palatal expansion. Angle Orthod. 2019 Sep;89(5):713-720. doi: 10.2319/070518-504.1. Epub 2019 Mar 21.
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PubMed Identifier
31982274
Citation
Kalita J, Kumar M, Misra UK. Serial single breath count is a reliable tool for monitoring respiratory functions in Guillain-Barre Syndrome. J Clin Neurosci. 2020 Feb;72:50-56. doi: 10.1016/j.jocn.2020.01.032. Epub 2020 Jan 22.
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PubMed Identifier
30475751
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Citation
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Citation
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Results Reference
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Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain

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