Neck PainNCT05552313
Effects of Kinesio Taping With Thoracic Manipulation in Mechanical Neck Pain Patients.
A study testing kinesio tape and standard therapy in people with Neck Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Neck pain is considered one of the very common cause of musculoskeletal pain. It is 4th leading cause of disability with a prevalence ranges between 30% and 50% among general population. cervical pain is among 5 most contributing factors in causing years lived with disability. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- kinesio tape and standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 1 Feb 2023
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
Neck pain is considered one of the very common cause of musculoskeletal pain. It is 4th leading cause of disability with a prevalence ranges between 30% and 50% among general population. cervical pain is among 5 most contributing factors in causing years lived with disability. Mechanical neck pain is identified by neck pain that gets evoked by sustained neck postures, neck mobility and by the palpation of cervical muscles. diagnosis is made through history and physical examination and can be helpful in differentiating from other causes of neck pain. functional impairments suffered by mechanical neck pain patients include weakness of deep cervical flexors, because of activation of superficial cervical muscles, reduced mobility of cervical spine, development of forward head posture, altered proprioception and disturbed balance leading to functional disability and decline in health related quality of life. there are different treatment approaches that include pharmacotherapy, manual therapy, active exercises, stretching, traction and electrotherapy. physiotherapy is often the first line treatment approach for individuals with mechanical, idiopathic and insidious neck pain but manual therapy is preferred through its biomechanical and neurophysiological responses that eventually leads to reduction in pain and improved function in clinical practice.thoracic manipulation and kinesio taping has proved to be very effective in treating mechanical neck pain patients according to several studies despite of their certain limitations. this study aims at evaluating effects of kinesio taping combined with thoracic manipulation in mechanical neck pain patients.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- kinesio tape, standard therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio tapeProcedure or surgery
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.
standard therapyProcedure or surgery
Thoracic manipulation along with conventional including Tens, stretching and strengthening exercises of entire neck musculature
| Study group | Role | What they receive |
|---|---|---|
| kinesio taping with thoracic manipulation and conventional treatment | Experimental | experimental group will be given kinesio taping with thoracic manipulation and conventional treatment Receives: Procedure: kinesio tape; Procedure: standard therapy |
| sham kinesio taping with thoracic manipulation and conventional treatment | Sham comparator | control group will be given sham kinesio taping with thoracic manipulation and conventional treatment Receives: Procedure: kinesio tape; Procedure: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain
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.
Measured: 4 weeks
Change in Cervical ROM:
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.
Measured: 4 weeks.
Change in Functional disability:
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
Measured: 4 weeks
Secondary outcomes (1)
Change in Deep neck flexor endurance:
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Mar 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Model description
- This study is a randomized controlled trial which will consist of 2 groups. Experimental group will be given kinesio taping along with thoracic manipulation and conventional treatment whereas control group will be given sham kinesio taping along with thoracic manipulation and conventional treatment. Both groups will be recruited concurrently.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552313
- Sponsor's protocol ID
- FUI/CTR/2022/12
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio Taping With Thoracic Manipulation in Mechanical Neck Pain Patients.
- ClinicalTrials.gov ID
- NCT05552313
- Acronym / sponsor ID
- FUI/CTR/2022/12
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 23 Sep 2022 (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.
Neck pain is considered one of the very common cause of musculoskeletal pain. It is 4th leading cause of disability with a prevalence ranges between 30% and 50% among general population. cervical pain is among 5 most contributing factors in causing years lived with disability. Mechanical neck pain is identified by neck pain that gets evoked by sustained neck postures, neck mobility and by the palpation of cervical muscles. diagnosis is made through history and physical examination and can be helpful in differentiating from other causes of neck pain. functional impairments suffered by mechanical neck pain patients include weakness of deep cervical flexors, because of activation of superficial cervical muscles, reduced mobility of cervical spine, development of forward head posture, altered proprioception and disturbed balance leading to functional disability and decline in health related quality of life. there are different treatment approaches that include pharmacotherapy, manual therapy, active exercises, stretching, traction and electrotherapy. physiotherapy is often the first line treatment approach for individuals with mechanical, idiopathic and insidious neck pain but manual therapy is preferred through its biomechanical and neurophysiological responses that eventually leads to reduction in pain and improved function in clinical practice.thoracic manipulation and kinesio taping has proved to be very effective in treating mechanical neck pain patients according to several studies despite of their certain limitations. this study aims at evaluating effects of kinesio taping combined with thoracic manipulation in mechanical neck pain patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial which will consist of 2 groups. Experimental group will be given kinesio taping along with thoracic manipulation and conventional treatment whereas control group will be given sham kinesio taping along with thoracic manipulation and conventional treatment. Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| kinesio taping with thoracic manipulation and conventional treatment | Experimental | Procedure: kinesio tape, Procedure: standard therapyexperimental group will be given kinesio taping with thoracic manipulation and conventional treatment |
| sham kinesio taping with thoracic manipulation and conventional treatment | Sham comparator | Procedure: kinesio tape, Procedure: standard therapycontrol group will be given sham kinesio taping with thoracic manipulation and conventional treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| kinesio tapekinesio 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. | Procedure or surgery | kinesio taping with thoracic manipulation and conventional treatment, sham kinesio taping with thoracic manipulation and conventional treatment |
| standard therapyThoracic manipulation along with conventional including Tens, stretching and strengthening exercises of entire neck musculature | Procedure or surgery | kinesio taping with thoracic manipulation and conventional treatment, sham kinesio taping with thoracic manipulation and conventional treatment |
Primary outcome
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.
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.
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
1 secondary outcome
Change in Deep neck flexor endurance:
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesio tape and standard therapy in people with Neck Pain, run by Foundation University Islamabad 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
change in pain (time frame: 4 weeks). The study lists 3 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 23 Sep 2022.