1. Home
  2. Approved trials
  3. » فارسی

Investigating the effects of adding kinesio taping to Mulligan'S mobilization on pain, range of motion, pain pressure thershold, joint proprioception and disability in patients with chronic nonspecific cervical pain

Protocol summary

Study aim
Assessing the effects of adding kinesio taping to Mulligan' mobilization on pain, range of motion, pressure pain threshold, proprioception, and disability in patients with non-specific chronic neck pain
Design
The study is a clinical trial with a single-blind (patient) design. Thirty patients with non-specific chronic neck pain are divided into two groups by simple randomization using a sealed envelope
Settings and conduct
A common issue of patients with neck pain is the disturbance in proprioception and the chronicity of symptoms, so this study aimed to investigate the effect of the of Mulligan's mobilization with kinesio tape on patients referring to the physiotherapy clinic of Tehran University, especially on proprioception.
Participants/Inclusion and exclusion criteria
Patients with non-specific chronic neck pain (aged 20 to 55, with a history of pain: at least six months, pain intensity: at least 30 on the VAS, and a minimum disability score of 10 on the NDI) are included. Patients with a history of vertebral fractures, dislocations, malignancies, infections, osteoporosis, ankylosing spondylitis, vascular neck disorders, dizziness, headaches, vestibular disorders, spinal malalignment, and those with referred pain to the hands are excluded from the study. Additionally, individuals who have received manual therapy within the past three months or those with sensitivity to Kinesio taping are excluded.
Intervention groups
Both groups initially receive conventional PT, including TENS, hot packs, and ultrasound. Subsequently, Mulligan's mobilization is applied to the C3 to C7 vertebrae. In the experimental group, in addition to these modalities, Kinesio tape is also applied. Furthermore, the patients are instructed in performing isometric neck exercises in six directions.
Main outcome variables
Pain intensity, active ROM, PPT, joint proprioception, disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220910055927N1
Registration date: 2023-09-13, 1402/06/22
Registration timing: registered_while_recruiting

Last update: 2023-09-13, 1402/06/22
Update count: 0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Fateme Dokhaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5505 0791
Email address
f-dokhaei@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of adding kinesio taping to Mulligan'S mobilization on pain, range of motion, pain pressure thershold, joint proprioception and disability in patients with chronic nonspecific cervical pain
Public title
The effects of manual therapy and taping in neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20 to 55 years with neck pain who have no specific anatomical or pathological cause for their pain have experienced neck pain for a minimum of 6 months The severity of patients' pain before intervention should be at least 30 on the visual analog scale. Their disability level, according to the neck disability index, should be a minimum of 10
Exclusion criteria:
Individuals with a history of trauma, fractures, or spinal and thoracic surgeries A history of vertebral dislocation or instability History of malignancy or infection Patients with osteoporosis People with rheumatoid arthritis or ankylosing spondylitis Presence of neck vascular disorders The radiation of pain from the neck to the arm, forearm, or hand Bad posture and deformity of Spinal column, dizziness, headache and vestibular disorders Individuals who have received any form of manual therapy for neck vertebrae within the past three months Individuals who are sensitive to kinesio tape
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
After initial assessments, patients are randomly assigned to one of the two groups of intervention and control (method: simple randomization - unit: individual). One envelope containing blue paper and one envelope containing red paper (randomization tool: sealed envelope) are given to the patients, if the patient choose the envelope containing blue paper, will be in the intervention group and if he chose the envelope containing red paper will be in the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding in this study will be single-blind, and in fact, participants will not know which study group they are in
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-11-13, 1401/08/22
Ethics committee reference number
IR.TUMS.FNM.REC.1401.105

Health conditions studied

1

Description of health condition studied
non specific chronic cervical pain
ICD-10 code
M50.9
ICD-10 code description
Cervical disc disorder, unspecified

Primary outcomes

1

Description
Pain Intensity
Timepoint
Before the intervention, immediately after the first intervention session and after 6th intervention session (last session)
Method of measurement
Visual Analogue Scale

2

Description
Active range of motion
Timepoint
Before the intervention, immediately after the first intervention session and after 6th intervention session (last session)
Method of measurement
Clinometer

3

Description
Pressure pain threshold
Timepoint
Before the intervention, immediately after the first intervention session and after 6th intervention session (last session)
Method of measurement
Algometer

4

Description
Joint proprioception
Timepoint
Before the intervention, immediately after the first intervention session and after 6th intervention session (last session)
Method of measurement
Joint repositioning tests

5

Description
Disability
Timepoint
Before the intervention, immediately after the first intervention session and after 6th intervention session (last session)
Method of measurement
Neck disability index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group 1 (n=15) received Mulligan mobilization of the third to seventh cervical vertebrae along with conventional PT (TENS, hot pack, ultrasound and neck isometric exercise), three times a week for two weeks.
Category
Rehabilitation

2

Description
Control group: Group 2 (n=15 ) after Mulligan's mobilization of third to seventh neck vertebrae and conventional PT (TENS, hot pack and ultrasound and neck isometric exercise), kinesio tape for neck extensor muscles is attached. The interventions is performed three times a week for two weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Fateme Dokhaei
Street address
Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 7752 8468
Email
f-dokhaei@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Dokhaei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche- Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
f-dokhaei@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche- Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
Shadmehr@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Dokhaei
Position
MSc. student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche- Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
f-dokhaei@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data potentially becomes shareable after anonymization of individuals
When the data will become available and for how long
The access period begins three months after the publication of the articles
To whom data/document is available
For researchers employed in academic, scientific, and hospital institutions
Under which criteria data/document could be used
Researchers working in the field of musculoskeletal physiotherapy and manual therapy.
From where data/document is obtainable
Applicants seeking documentation can contact Mrs. Fateme Dokhaei via email. f-dokhaei@razi.tums.ac.ir
What processes are involved for a request to access data/document
Once the necessary conditions are met, the information will be available to them within one month.
Comments
Loading...