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Effects of Home-Based Exercise Manual on Pain and Disability in Patients of Postural Neck Pain

Primary Purpose

Postural Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Home-based Exercise Manual
Conventional PT
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural Neck Pain focused on measuring Postural Neck Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with postural neck pain aged 18-60 years shall be included.
  • Patients experiencing postural neck pain at least once a week.
  • A symptom duration of greater than 3 months.
  • Postural neck pain that is aggravated by the sustained postural loading, and relieved by postural modification.
  • Patients who are able to read and write.

Exclusion Criteria:

  • Neck pain due to specific causes i.e. disc protrusion, radicular syndrome
  • Any accidental injury of spine
  • Inflammatory rheumatic disease
  • Congenital deformity of the spine
  • Spinal canal stenosis
  • Neoplasm
  • Females who are pregnant
  • Patients who had spinal surgery within the previous 12 months or any other invasive treatment of the spine within the previous 4 weeks.

Sites / Locations

  • Pakistan Society for Rehabilitation of the Disabled

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arms

Assigned Interventions

Arm Description

Control group: in control group moist heating pads along with TENS shall be applied on neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed.

Experimental group: in the experimental group we will provide moist heating pads along with TENS on the neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed. Patients in the experimental group will also receive a home-based exercise manual.

Outcomes

Primary Outcome Measures

Numerical Pain Rating Scale (NPRS)
Pain will be measured by Numerical Pain Rating Scale (NPRS), in which patients are asked to circle the number between 0 and 10. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." The patient picks (verbal version) or draws a circle around.
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a self-report questionnaire which is used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. This questionnaire is used to gather the details about the intensity of neck pain among patients that has affected the capability to manage in daily routine. Every single section of this questionnaire is scored on a 0 to 5 rating scale, in which 0 means "no pain" whereas 5 means "worst imaginable pain".

Secondary Outcome Measures

Full Information

First Posted
February 19, 2022
Last Updated
May 7, 2022
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05261698
Brief Title
Effects of Home-Based Exercise Manual on Pain and Disability in Patients of Postural Neck Pain
Official Title
Effects of Routine Physical Therapy With and Without Home-Based Exercise Manual on Pain and Disability in Patients of Postural Neck Pain: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
May 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

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
The main aim of this study is to determine the effects of routine physical therapy with and without home-based exercise manual on pain and disability in patients of postural neck pain. To exceptional time, the effects and outcomes of home-based exercise manual for the patients with postural neck pain have not yet been explored. Due to the current Covid-19 pandemic and social isolation, most of the individuals with office based occupations are performing their duties from their homes, which has some negative impact on their neck biomechanics and leads to the postural neck pain, this study will not only enlighten the beneficial effects of home-based exercise manual for the patients of postural neck pain, to reduce the risk of disability and improve their quality of life, but it will also be cost effective for them.
Detailed Description
After back pain, most commonly found musculoskeletal ailment is the neck pain. Due to the poor neck posture, postural neck pain appears. It is estimated that, about 60% of the neck pain patients' have the forward head posture. Many people visit hospitals or other medical centers at least once in their life due to this problem. Those individuals with chronic neck pain who work in offices, industries or perform other computer-based tasks, that require sitting for longer period of time have altered postural behaviors. Persistent neck pain has the negative impact as it has the potential to change the biomechanics of cervical spine specifically in individuals who spend most of their time in sitting position in front of computer screens. Continuous postural neck pain may lead to the forward head posture that rises load on the posterior structures of the cervical spine such as ligaments, muscles, bones and joint capsules and brings changes in scapular kinetics and kinematics. According to the previous researches, forward head posture causes tightening of the shoulder and anterior neck muscles, shortening of the posterior neck extensors, and affects the kinematics and position of the scapula. Proper posture of the body is believed to be the state in which there is a musculoskeletal balance and minimal amount of strain and stress on the body. However most of the people are not able to maintain that equilibrium in the musculoskeletal structures of the body. An ideal posture is considered only when the external auditory meatus is lined up with the vertical postural line. As seen in in the lateral view, the vertical line passes through external auditory meatus, the shoulder joint, slightly behind the hip joint, through the center of the knee joint and slightly in front of the ankle joint. Postural neck pain is believed to be associated with the forward head posture and is one of the common types of poor head posture seen in patients with neck disorders. Neck pain is the most commonly occurring clinical condition, and its associated social and economic costs related to disability and days off work are just about equal to the lumbar pain. Individuals with the postural neck pain have been reported with the change in muscular control such as increased activity of the superficial muscles of the cervical spine and upper trapezius. Although the exact association between posture and neck pain is unresolved. Cervical neck posture is believed to have impact on dorsal neck muscle activity during lifting or even at rest. Moreover, postural neck pain may lead to the forward head posture linked with the thoracic kyphosis which has indirect impact on the rotational range of motion and cervical flexion. Occupations with sustained computer use and prolong computer usage may lead to the functional kyphosis, that seems to affect posture of the neck and scapular positioning and activity of the upper trapezius. Modifications in the workplace environment and postural correction have been shown in reducing postural neck pain. The main aim of the study is to compare the effects of routine physical therapy with and without home-based exercise manual on pain and disability in patients of postural neck pain.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arms
Arm Type
Active Comparator
Arm Description
Control group: in control group moist heating pads along with TENS shall be applied on neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed.
Arm Title
Assigned Interventions
Arm Type
Experimental
Arm Description
Experimental group: in the experimental group we will provide moist heating pads along with TENS on the neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed. Patients in the experimental group will also receive a home-based exercise manual.
Intervention Type
Other
Intervention Name(s)
Home-based Exercise Manual
Intervention Description
in the experimental group we will provide moist heating pads along with TENS on the neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed. Patients in the experimental group will also receive a home-based exercise manual.
Intervention Type
Other
Intervention Name(s)
Conventional PT
Intervention Description
In this group patients will receive routine physical therapy including hot pack for 10 minutes, stretching, strengthening exercise and TENS at the end of each session.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NPRS)
Description
Pain will be measured by Numerical Pain Rating Scale (NPRS), in which patients are asked to circle the number between 0 and 10. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." The patient picks (verbal version) or draws a circle around.
Time Frame
2 weeks
Title
Neck Disability Index (NDI)
Description
The Neck Disability Index (NDI) is a self-report questionnaire which is used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. This questionnaire is used to gather the details about the intensity of neck pain among patients that has affected the capability to manage in daily routine. Every single section of this questionnaire is scored on a 0 to 5 rating scale, in which 0 means "no pain" whereas 5 means "worst imaginable pain".
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with postural neck pain aged 18-60 years shall be included. Patients experiencing postural neck pain at least once a week. A symptom duration of greater than 3 months. Postural neck pain that is aggravated by the sustained postural loading, and relieved by postural modification. Patients who are able to read and write. Exclusion Criteria: Neck pain due to specific causes i.e. disc protrusion, radicular syndrome Any accidental injury of spine Inflammatory rheumatic disease Congenital deformity of the spine Spinal canal stenosis Neoplasm Females who are pregnant Patients who had spinal surgery within the previous 12 months or any other invasive treatment of the spine within the previous 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Adil, MPHIL-MSK*
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Society for Rehabilitation of the Disabled
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54770
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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24298492
Citation
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Effects of Home-Based Exercise Manual on Pain and Disability in Patients of Postural Neck Pain

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