Cervical SpondylosisNCT06351254
Kinesthetic Exercises and Sine Sound Waves in Cervical Spondylosis
A study testing Sine sound waves, Kinesthetic exercises and Sine sound waves plus kinesthetic exercises in people with Cervical Spondylosis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this Randomized control trial is to determine the Effect of kinesthetic exercises and sound waves on pain, ROM, shoulder alignment and disability in cervical spondylosis. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Sine sound waves, Kinesthetic exercises and Sine sound waves plus kinesthetic exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2023to 1 Jun 2024
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- neck pain
- age 45-60 years
- radiography showed degenerative changes
Who cannot join
- cervical myelopathy
- whiplash injury
- infection involving the c-spine
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Kinesthetic Exercises and Sine Sound Waves on Pain, Range of Motion, Disability and Alignment in Cervical Spondylosis
The goal of this Randomized control trial is to determine the Effect of kinesthetic exercises and sound waves on pain, ROM, shoulder alignment and disability in cervical spondylosis. The main question it aims to answer is:
Weather sine sound and kinesthetic exercise are effective in management of pain, rom, alignment, and disability in patients that are suffering from cervical spondylosis
Read the detailed description
Cervical spondylosis is a progressive disease defined by degenerative changes affecting the vertebrae, intervertebral disks, facets, and associated ligaments. Symptoms of cervical spondylosis manifest as neck pain and neck stiffness and can be accompanied by radicular symptoms when there is compression of neural structures. The degenerative changes are intervertebral disc degeneration, osteophyte formation, and ligamentum flavum and facet hypertrophy. The sine sound waves approach aims to provide orthopaedic spinal treatment through focused vibroacoustic treatment (fVAT) and manage the biomechanical aspect of back pain. Vibroacoustic therapy has been indicated for patients with a range of musculoskeletal, neurological, and haemodynamic problems demonstrating positive changes in pain, spasticity, movement control, and specifically fatigue and anxiety in those with spinalcord or brain injuries. For neck pain syndromes, the kinesthetic rehabilitation exercises (i. e.,eye-follow exercises, head relocation exercises, eye-head coordination, and gaze stability exercises) are developed to improve or restore somatosensory and sensorimotor function by enhancing tactile afferents cues. Kinaesthetic exercises have an added advantage over the conventional exercise programs as it uses an unconscious component of proprioceptive signals for the automatic control of cervical muscle tone and posture.
The research include 3 intervention groups Group A will be give sine sound waves treatment 6 sessions 3 times a week followed by 6 sessions 2 times a week. Group B will be given kinesthetic exercise for 6 weeks. And group C will be given combination of both group A and group B treatments. Outcomes, encompassing pain levels, range of motion (ROM), and Neck Disability Index (NDI) scores, will be evaluated using the Numeric Pain Rating Scale, Goniometer, and Crom device. Data analysis will employ SPSS version 26. Data will be collected at baseline, immediately post-intervention, and at follow-up intervals. Statistical analyses will be conducted to assess and compare the effects of the interventions on the primary and secondary outcomes, thereby addressing the research question regarding their relative efficacy.
- Conditions
- Cervical Spondylosis
- Being tested
- Sine sound waves, Kinesthetic exercises, Sine sound waves plus kinesthetic exercises
- Keywords
- Alignment, Cervical Spondylosis.
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sine sound wavesProcedure or surgery
Also called Vibro-percussive waves
Group A 8 participants will be given sine sound waves treatment with the frequency of 80 pulses on C1 vertebrae. Treatment session will be 6 session 3 times a week followed by 6 sessions 2 times a week.
Kinesthetic exercisesProcedure or surgery
Kinesthetic exercises was conducted for GROUP 2 8 patients for 6 weeks. Before and after assessment was taken to track patient progress. Cervicocephalic kinesthetic sensibility tests were performed. The first test was Head-to-Neutral Head Position(NHP) repositioning test. In the second repositioning test is Head-toTarget repositioning tests.
Sine sound waves plus kinesthetic exercisesProcedure or surgery
Group C 8 was given combine treatment of sine sound waves and kinesthetic exercises before and after measurement was taken.
| Study group | Role | What they receive |
|---|---|---|
| Sine sound waves treatment | Experimental | sine sound waves Receives: Procedure: Sine sound waves |
| Kinesthetic exercises | Experimental | Head to neutral head position test and head to target repositioning test Receives: Procedure: Kinesthetic exercises |
| Sine sound waves plus kinesthetic exercises | Experimental | Combination of sine sound waves and kinesthetic exercises Receives: Procedure: Sine sound waves plus kinesthetic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 6 weeks
Inclinometer
An inclinometer (or clinometer), is an instrument used for measuring the angles of slope/tilt and elevation/depression of an object with respect to gravity. The resulting measurement is either given an angular measurement (degrees, minutes, seconds etc.) or as a percentage with reference to a level zero plane.
Measured: 6 weeks
Goniometer
A goniometer is the most common instrument used to measure range of motion. If a patient has altered range of motion in a particular joint, the therapist can use a goniometer to assess what the range of motion is at the initial assessment, and then make sure the intervention is working by using the goniometer in subsequent sessions to assess the effectiveness of the intervention.
Measured: 6 weeks
NDI
Patient neck disability index is assessed through this index
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start20 Nov 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
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 Riphah International UniversityThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, Ms, Principal investigator, Riphah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351254
- Sponsor's protocol ID
- REC/RCR & AHS/23/01101nayab
- Status last verified
- Sep 2024
- First submitted
- 2 Apr 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesthetic Exercises and Sine Sound Waves on Pain, Range of Motion, Disability and Alignment in Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT06351254
- Acronym / sponsor ID
- REC/RCR & AHS/23/01101nayab
- Conditions
- Cervical Spondylosis
- Keywords
- Alignment, Cervical Spondylosis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 8 Apr 2024 (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.
The goal of this Randomized control trial is to determine the Effect of kinesthetic exercises and sound waves on pain, ROM, shoulder alignment and disability in cervical spondylosis. The main question it aims to answer is:
Weather sine sound and kinesthetic exercise are effective in management of pain, rom, alignment, and disability in patients that are suffering from cervical spondylosis
Detailed description
Cervical spondylosis is a progressive disease defined by degenerative changes affecting the vertebrae, intervertebral disks, facets, and associated ligaments. Symptoms of cervical spondylosis manifest as neck pain and neck stiffness and can be accompanied by radicular symptoms when there is compression of neural structures. The degenerative changes are intervertebral disc degeneration, osteophyte formation, and ligamentum flavum and facet hypertrophy. The sine sound waves approach aims to provide orthopaedic spinal treatment through focused vibroacoustic treatment (fVAT) and manage the biomechanical aspect of back pain. Vibroacoustic therapy has been indicated for patients with a range of musculoskeletal, neurological, and haemodynamic problems demonstrating positive changes in pain, spasticity, movement control, and specifically fatigue and anxiety in those with spinalcord or brain injuries. For neck pain syndromes, the kinesthetic rehabilitation exercises (i. e.,eye-follow exercises, head relocation exercises, eye-head coordination, and gaze stability exercises) are developed to improve or restore somatosensory and sensorimotor function by enhancing tactile afferents cues. Kinaesthetic exercises have an added advantage over the conventional exercise programs as it uses an unconscious component of proprioceptive signals for the automatic control of cervical muscle tone and posture.
The research include 3 intervention groups Group A will be give sine sound waves treatment 6 sessions 3 times a week followed by 6 sessions 2 times a week. Group B will be given kinesthetic exercise for 6 weeks. And group C will be given combination of both group A and group B treatments. Outcomes, encompassing pain levels, range of motion (ROM), and Neck Disability Index (NDI) scores, will be evaluated using the Numeric Pain Rating Scale, Goniometer, and Crom device. Data analysis will employ SPSS version 26. Data will be collected at baseline, immediately post-intervention, and at follow-up intervals. Statistical analyses will be conducted to assess and compare the effects of the interventions on the primary and secondary outcomes, thereby addressing the research question regarding their relative efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sine sound waves treatment | Experimental | Procedure: Sine sound wavessine sound waves |
| Kinesthetic exercises | Experimental | Procedure: Kinesthetic exercisesHead to neutral head position test and head to target repositioning test |
| Sine sound waves plus kinesthetic exercises | Experimental | Procedure: Sine sound waves plus kinesthetic exercisesCombination of sine sound waves and kinesthetic exercises |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- neck pain
- age 45-60 years
- radiography showed degenerative changes
Key exclusion criteria (3 listed)
- cervical myelopathy
- whiplash injury
- infection involving the c-spine
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 |
|---|---|---|
| Sine sound wavesAlso: Vibro-percussive wavesGroup A 8 participants will be given sine sound waves treatment with the frequency of 80 pulses on C1 vertebrae. Treatment session will be 6 session 3 times a week followed by 6 sessions 2 times a week. | Procedure or surgery | Sine sound waves treatment |
| Kinesthetic exercisesKinesthetic exercises was conducted for GROUP 2 8 patients for 6 weeks. Before and after assessment was taken to track patient progress. Cervicocephalic kinesthetic sensibility tests were performed. The first test was Head-to-Neutral Head Position(NHP) repositioning test. In the second repositioning test is Head-toTarget repositioning tests. | Procedure or surgery | Kinesthetic exercises |
| Sine sound waves plus kinesthetic exercisesGroup C 8 was given combine treatment of sine sound waves and kinesthetic exercises before and after measurement was taken. | Procedure or surgery | Sine sound waves plus kinesthetic exercises |
Primary outcome
NPRS
Time frame: 6 weeks
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Inclinometer
Time frame: 6 weeks
An inclinometer (or clinometer), is an instrument used for measuring the angles of slope/tilt and elevation/depression of an object with respect to gravity. The resulting measurement is either given an angular measurement (degrees, minutes, seconds etc.) or as a percentage with reference to a level zero plane.
Goniometer
Time frame: 6 weeks
A goniometer is the most common instrument used to measure range of motion. If a patient has altered range of motion in a particular joint, the therapist can use a goniometer to assess what the range of motion is at the initial assessment, and then make sure the intervention is working by using the goniometer in subsequent sessions to assess the effectiveness of the intervention.
NDI
Time frame: 6 weeks
Patient neck disability index is assessed through this index
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 4 Sep 2024.
- 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.
Muhammad Sanaullah, Ms principal investigator
Riphah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sine sound waves, Kinesthetic exercises and Sine sound waves plus kinesthetic exercises in people with Cervical Spondylosis, run by Riphah International University 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 3 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 4 Sep 2024. 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?
NPRS (time frame: 6 weeks). The study lists 4 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 4 Sep 2024.