Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
Primary Purpose
Cervical Spondylosis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Diaphragmatic and pursed lip breathing
Routine Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spondylosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosed patients with cervical spondylosis
- Both male and female
- Age from 40-60 years
Exclusion Criteria:
- Any deformity of spine
- Any surgery of spine
- Tumor
- Trauma & Fracture
- Cervical radiculopathy
- Respiratory diseases
Sites / Locations
- University of Lahore Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Routine Physical Therapy
Breathing Exercises along with routine physical therapy
Arm Description
This group received only routine physical therapy. This includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions (3 sessions per week)
This group received routine physical therapy along with breathing exercises. This includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions (3 sessions per week).
Outcomes
Primary Outcome Measures
Change in Visual Analogue Scale score
Visual analogue scale was used to assess neck pain. Score ranges from 0-10. 0 shows least pain and 10 shows worst pain
Change in Universal Goniometer readings
Universal Goniometer was used to assess cervical range of motion.
Change in Neck Disability Index score
Neck Disability Index was used to assess neck disability. Score ranges from 0-50. 0 shows minimum disability and 50 shows maximum disability.
Secondary Outcome Measures
Change in SF-36 Questionnaire score
SF-36 Questionnaire was used to assess quality of life. Scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Full Information
NCT ID
NCT05086367
First Posted
September 11, 2021
Last Updated
October 7, 2021
Sponsor
University of Lahore
1. Study Identification
Unique Protocol Identification Number
NCT05086367
Brief Title
Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
Official Title
Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
August 7, 2021 (Actual)
Study Completion Date
September 7, 2021 (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
Yes
5. Study Description
Brief Summary
A randomized controlled trial was conducted on 72 diagnosed patients with cervical spondylosis at University of Lahore Teaching hospital. The study was completed within 9 months after the approval of synopsis. Patients who fulfill the inclusion criteria were identified by individual physiotherapist and were enrolled for particular study. Informed written consent was be taken by the patients and were randomly allocated into two groups. The total numbers of sessions were 12 (3 sessions per week). The study was single blinded. The assessor was unaware of the treatment given to both groups.
Control group received only routine physical therapy. This includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions and three times per week.
Experimental group received routine physical therapy along with breathing exercises. This includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions and three times per week.
Baseline data was collected before first treatment then after 4th, 8th and 12th session.
The outcome measures were neck pain, ROM, neck disability and quality of life and were analyzed by using SPSS 26 and then results and conclusion were drawn.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine Physical Therapy
Arm Type
Active Comparator
Arm Description
This group received only routine physical therapy. This includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions (3 sessions per week)
Arm Title
Breathing Exercises along with routine physical therapy
Arm Type
Experimental
Arm Description
This group received routine physical therapy along with breathing exercises. This includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions (3 sessions per week).
Intervention Type
Other
Intervention Name(s)
Diaphragmatic and pursed lip breathing
Intervention Description
Breathing exercises were performed. Two breathing techniques were applied to the participants. Diaphragmatic and pursed lip breathing were intervened along with routine physical therapy.
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Intervention Description
Routine physical therapy exercises were performed in which neck isometrics and neck range of motion exercises were performed
Primary Outcome Measure Information:
Title
Change in Visual Analogue Scale score
Description
Visual analogue scale was used to assess neck pain. Score ranges from 0-10. 0 shows least pain and 10 shows worst pain
Time Frame
Change from pre-intervention to 4 weeks
Title
Change in Universal Goniometer readings
Description
Universal Goniometer was used to assess cervical range of motion.
Time Frame
Change from pre-intervention to 4 weeks
Title
Change in Neck Disability Index score
Description
Neck Disability Index was used to assess neck disability. Score ranges from 0-50. 0 shows minimum disability and 50 shows maximum disability.
Time Frame
Change from pre-intervention to 4 weeks
Secondary Outcome Measure Information:
Title
Change in SF-36 Questionnaire score
Description
SF-36 Questionnaire was used to assess quality of life. Scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time Frame
Change from pre-intervention to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed patients with cervical spondylosis
Both male and female
Age from 40-60 years
Exclusion Criteria:
Any deformity of spine
Any surgery of spine
Tumor
Trauma & Fracture
Cervical radiculopathy
Respiratory diseases
Facility Information:
Facility Name
University of Lahore Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
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