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NCT Number: NCT06351254

Kinesthetic Exercises and Sine Sound Waves 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

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Key information

Conditions

Cervical Spondylosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylosis

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah international university

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • neck pain
  • age 45-60 years
  • radiography showed degenerative changes

Exclusion criteria

  • cervical myelopathy
  • whiplash injury
  • infection involving the c-spine

Treatment and study plan

Sine sound waves

Procedure

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.

Other names: Vibro-percussive waves

Kinesthetic exercises

Procedure

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 exercises

Procedure

Group C 8 was given combine treatment of sine sound waves and kinesthetic exercises before and after measurement was taken.

Primary outcomes

  1. 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").

  2. 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.

  3. 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.

  4. NDI

    Time frame: 6 weeks

    Patient neck disability index is assessed through this index

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Kinesthetic Exercises and Sine Sound Waves on Pain, Range of Motion, Disability and Alignment in Cervical Spondylosis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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