- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05086367
Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- University of Lahore Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Routine Physical Therapy
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)
|
Routine physical therapy exercises were performed in which neck isometrics and neck range of motion exercises were performed
|
|
Experimental: Breathing Exercises along with routine physical therapy
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).
|
Breathing exercises were performed.
Two breathing techniques were applied to the participants.
Diaphragmatic and pursed lip breathing were intervened along with routine physical therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Visual Analogue Scale score
Time Frame: Change from pre-intervention to 4 weeks
|
Visual analogue scale was used to assess neck pain.
Score ranges from 0-10.
0 shows least pain and 10 shows worst pain
|
Change from pre-intervention to 4 weeks
|
|
Change in Universal Goniometer readings
Time Frame: Change from pre-intervention to 4 weeks
|
Universal Goniometer was used to assess cervical range of motion.
|
Change from pre-intervention to 4 weeks
|
|
Change in Neck Disability Index score
Time Frame: Change from pre-intervention to 4 weeks
|
Neck Disability Index was used to assess neck disability.
Score ranges from 0-50.
0 shows minimum disability and 50 shows maximum disability.
|
Change from pre-intervention to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in SF-36 Questionnaire score
Time Frame: Change from pre-intervention to 4 weeks
|
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.
|
Change from pre-intervention to 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-UOL-FAHS/770-1/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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