NCT06351254

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

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 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

April 2, 2024

Last Update Submit

September 3, 2024

Conditions

Cervical Spondylosis

Keywords

Alignment, Cervical Spondylosis.

Outcome Measures

Primary Outcomes (4)

  • 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").

    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.

    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.

    6 weeks

  • NDI

    Patient neck disability index is assessed through this index

    6 weeks

Study Arms (3)

Sine sound waves treatment

EXPERIMENTAL

sine sound waves

Procedure: Sine sound waves

Kinesthetic exercises

EXPERIMENTAL

Head to neutral head position test and head to target repositioning test

Procedure: Kinesthetic exercises

Sine sound waves plus kinesthetic exercises

EXPERIMENTAL

Combination of sine sound waves and kinesthetic exercises

Procedure: Sine sound waves plus kinesthetic exercises

Interventions

Sine sound wavesPROCEDURE

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.

Also known as: Vibro-percussive waves
Sine sound waves treatment
Kinesthetic exercisesPROCEDURE

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.

Kinesthetic exercises
Sine sound waves plus kinesthetic exercisesPROCEDURE

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

Sine sound waves plus kinesthetic exercises

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Muhammad Sanaullah, Ms

    Riphah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 8, 2024

Study Start

November 20, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

September 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)