Cervical SpondylosisNCT05086367
Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
A study testing Diaphragmatic and pursed lip breathing and Routine Physical Therapy in people with Cervical Spondylosis, run by University of Lahore at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Diaphragmatic and pursed lip breathing and Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Nov 2020to 7 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed patients with cervical spondylosis
- Both male and female
- Age from 40-60 years
Who cannot join
- Any deformity of spine
- Any surgery of spine
- Tumor
- Trauma \& Fracture
- Cervical radiculopathy
- Respiratory diseases
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 54000
About this study
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.
Read more
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.
- Conditions
- Cervical Spondylosis
- Being tested
- Diaphragmatic and pursed lip breathing, Routine Physical Therapy
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic and pursed lip breathingOther
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 TherapyOther
Routine physical therapy exercises were performed in which neck isometrics and neck range of motion exercises were performed
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Other: Diaphragmatic and pursed lip breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from pre-intervention to 4 weeks
Change in Universal Goniometer readings
Universal Goniometer was used to assess cervical range of motion.
Measured: 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.
Measured: Change from pre-intervention to 4 weeks
Secondary outcomes (1)
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.
Measured: Change from pre-intervention to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start13 Nov 2020
- Primary completion7 Aug 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086367
- Sponsor's protocol ID
- IRB-UOL-FAHS/770-1/2020
- Status last verified
- Sep 2021
- First submitted
- 11 Sep 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT05086367
- Acronym / sponsor ID
- IRB-UOL-FAHS/770-1/2020
- Conditions
- Cervical Spondylosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 7 Aug 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Routine Physical Therapy | Active comparator | Other: Routine Physical TherapyThis 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) |
| Breathing Exercises along with routine physical therapy | Experimental | Other: Diaphragmatic and pursed lip breathingThis 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). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed patients with cervical spondylosis
- Both male and female
- Age from 40-60 years
Key exclusion criteria (6 listed)
- Any deformity of spine
- Any surgery of spine
- Tumor
- Trauma \& Fracture
- Cervical radiculopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic and pursed lip breathingBreathing exercises were performed. Two breathing techniques were applied to the participants. Diaphragmatic and pursed lip breathing were intervened along with routine physical therapy. | Other | Breathing Exercises along with routine physical therapy |
| Routine Physical TherapyRoutine physical therapy exercises were performed in which neck isometrics and neck range of motion exercises were performed | Other | Routine Physical Therapy |
Primary outcome
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 in Universal Goniometer readings
Time frame: Change from pre-intervention to 4 weeks
Universal Goniometer was used to assess cervical range of motion.
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.
1 secondary outcome
Change in SF-36 Questionnaire score
Time frame: Change from pre-intervention to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic and pursed lip breathing and Routine Physical Therapy in people with Cervical Spondylosis, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogue Scale score (time frame: Change from pre-intervention to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.