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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05086367
Other study ID # IRB-UOL-FAHS/770-1/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 13, 2020
Est. completion date September 7, 2021

Study information

Verified date September 2021
Source University of Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 7, 2021
Est. primary completion date August 7, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Diaphragmatic and pursed lip breathing
Breathing exercises were performed. Two breathing techniques were applied to the participants. Diaphragmatic and pursed lip breathing were intervened along with routine physical therapy.
Routine Physical Therapy
Routine physical therapy exercises were performed in which neck isometrics and neck range of motion exercises were performed

Locations

Country Name City State
Pakistan University of Lahore Teaching Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 from pre-intervention to 4 weeks
Primary Change in Universal Goniometer readings Universal Goniometer was used to assess cervical range of motion. Change from pre-intervention to 4 weeks
Primary 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. Change from pre-intervention to 4 weeks
Secondary 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. Change from pre-intervention to 4 weeks
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