Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis

• Sponsor: University of Lahore (Other)
• Overall Status: Completed
• CT.gov ID: NCT05086367
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.8
• Patients Per Site Per Month: 7.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Spondylosis	Other: Diaphragmatic and pursed lip breathing; Other: Routine Physical Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Controlled TrialRandomized Controlled Trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
• Actual Study Start Date: Nov 13, 2020
• Actual Primary Completion Date: Aug 7, 2021
• Actual Study Completion Date: Sep 7, 2021

Arms and Interventions

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)	Other: Routine Physical Therapy; 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).	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.

Outcome Measures

Primary Outcome Measures

1. Change in Visual Analogue Scale score [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

2. Change in Universal Goniometer readings [Change from pre-intervention to 4 weeks]

   Universal Goniometer was used to assess cervical range of motion.

3. Change in Neck Disability Index score [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.

Secondary Outcome Measures

1. Change in SF-36 Questionnaire score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Lahore Teaching Hospital	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

• University of Lahore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Lahore
• ClinicalTrials.gov Identifier: NCT05086367
• Other Study ID Numbers: IRB-UOL-FAHS/770-1/2020
• First Posted: Oct 20, 2021
• Last Update Posted: Oct 20, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spondylosis

Study Results

No Results Posted as of Oct 20, 2021