- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05552313
Effects of Kinesio Taping With Thoracic Manipulation in Mechanical Neck Pain Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As young population and office workers are inclined towards computer work, so they tend to develop forward head posture or other muscular imbalance leading towards mechanical neck pain, so this population is considered in this study. substantial amount of evidence is available on the persisting treatment options and also on thoracic manipulation and kinesio taping, but none of them evaluated combined effects of both interventions. so this study aims at evaluating combined effects of kinesio taping and thoracic manipulation on pain, functional disability and cervical ROM in mechanical neck pain patients. if there are improved results by combining these interventions then clinicians can use them in combination for better results on their patients. moreover patients can also benefit from this study as they can get back to work early and lead towards better quality of life.
This randomized controlled trial will be conducted in Rehab OPD of fauji foundation hospital and foundation university institute of rehabilitation sciences using non probability purposive sampling. Sample size has been calculated as 30 using open epi sample size calculator. Patients with primary complaint of mechanical neck pain referred to rehab opd of FFH and patients of mechanical neck pain from fuirs will be recruited according to eligibility criteria. Participants will be briefed regarding the study objectives, study procedures, risks and benefits of treatment, voluntary participation and a right to withdraw. After taking informed consent, demographic data and baseline measurements, participants will be randomly allocateditno one of two groups using coin toss method.Control group will recieve sham kinesio taping along with thoracic manipulatio and conventional physiotherapy treatment whereas experimental group will reieve cervical kinesio taping along with thoracic manipulation and conventional physiotherapy treatment.
Group 1 (experimental group): Upper thoracic manipulation using screw thrust technique. conventional treatment would include moist heat pad for 10 minutes,Tens for 10 minutes, stretching and strenghtning of sternocliedomastoid, scalnes, deep neck flexors, suboccipitals and upper and middle fibres of trapezius. kinesio taping: kinesio tape in a Y shape is applied from C1 to T1 with 15% to 20% stretch. Another I strip is applied horizontly from C1 to C4 with 15% to 20% stretch.
Group 2 (control group): upper thoracic manipulation using screw thrust technique. conventional treatment would include moist heat pad for 10 minutes, Tens for 10 minutes, stretching and strenghtning of sternocliedomastoid, scalenes, deep neck flexors, suboccipitals and upper and middle fibres of trapezius. kinesio taping: sham kinesio tape is applied.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Foundation University College of Physical Therapy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- individuals aged 18-35 years, unilateral or bilateral pain in posterior neck, shoulder or cervical region when moving or on palpations.
- individuals with thoracic hypomobility.
- symptoms of duration more than 3 months.
- NPRS scoring of equal to or greater than 4 points.
- neck disability index score of 20% or above.
Exclusion criteria:
- history of neurologic signs or symptoms suggestive of nerve root involvement.
- prior cervical or thoracic spine fractures, dislocation or surgeries, spinal osteoporosis or infection, or whiplash.
- pregnancy
- any contraindication to manipulation or any tape allergy.
- hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: kinesio taping with thoracic manipulation and conventional treatment
experimental group will be given kinesio taping with thoracic manipulation and conventional treatment
|
kinesio tape will be applied while patient is in sitting position.
Y strip will be applied along C1 till T1.while patient's cervical spine is in contalateral side bending and rotation.
same will be performed on the other side.
on top of it, an I strip will be applied horizontly along C1 to C4.
Both strips will be applied with 15% to 20% stretch.
Thoracic manipulation along with conventional including Tens, stretching and strengthening exercises of entire neck musculature
|
|
SHAM_COMPARATOR: sham kinesio taping with thoracic manipulation and conventional treatment
control group will be given sham kinesio taping with thoracic manipulation and conventional treatment
|
kinesio tape will be applied while patient is in sitting position.
Y strip will be applied along C1 till T1.while patient's cervical spine is in contalateral side bending and rotation.
same will be performed on the other side.
on top of it, an I strip will be applied horizontly along C1 to C4.
Both strips will be applied with 15% to 20% stretch.
Thoracic manipulation along with conventional including Tens, stretching and strengthening exercises of entire neck musculature
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in pain
Time Frame: 4 weeks
|
pain will be measured using numeric pain rating scale.
nprs is a 10 item scale.
higher result shows more pain and low results show less pain.
|
4 weeks
|
|
Change in Cervical ROM:
Time Frame: 4 weeks.
|
Cervical ROM will be measured using cervical ROM device.
Cervical flexion, cervical extension, cervical right and left side bending, cervical right and left rotation.
During evaluation, patient would be asked to perform all movements.
Three repetitions will be recorded and the final mean error calculated between angles.
|
4 weeks.
|
|
Change in Functional disability:
Time Frame: 4 weeks
|
Functional disability will be measured using neck disability index questionnaire and it is used to assess self-rated disability in neck pain patients.
It has 10 items and response to every item is rated on a 6 point scale from 0, indicating no disability and 5, indicating complete disability.
The responses for every item are added for a total score that ranges between 0 and 50.
Higher scores represent increased level of disability
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Deep neck flexor endurance:
Time Frame: 4 weeks
|
It will be measured using deep neck flexor endurance test.
Patient would be supine or hook lying and will be asked to perform chin tuck in and hold his head 1 inch off the table.
The mean deep neck flexor endurance hold time will be recorded.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2022/12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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