NCT05086367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
Last Updated

October 20, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

September 11, 2021

Last Update Submit

October 7, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • Change in Universal Goniometer readings

    Universal Goniometer was used to assess cervical range of motion.

    Change from pre-intervention to 4 weeks

  • 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 Outcomes (1)

  • Change in SF-36 Questionnaire score

    Change from pre-intervention to 4 weeks

Study Arms (2)

Routine Physical Therapy

ACTIVE COMPARATOR

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

Breathing Exercises along with routine physical therapy

EXPERIMENTAL

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

Interventions

Breathing exercises were performed. Two breathing techniques were applied to the participants. Diaphragmatic and pursed lip breathing were intervened along with routine physical therapy.

Breathing Exercises along with routine physical therapy

Routine physical therapy exercises were performed in which neck isometrics and neck range of motion exercises were performed

Routine Physical Therapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed patients with cervical spondylosis
  • Both male and female
  • Age from 40-60 years

You may not qualify if:

  • Any deformity of spine
  • Any surgery of spine
  • Tumor
  • Trauma \& Fracture
  • Cervical radiculopathy
  • Respiratory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Spondylosis

Interventions

Contraceptive Devices, Female

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Contraceptive DevicesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2021

First Posted

October 20, 2021

Study Start

November 13, 2020

Primary Completion

August 7, 2021

Study Completion

September 7, 2021

Last Updated

October 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations