Cervical PainNCT05191043
Effects of Kinesio Taping in Addition to Routine Physical Therapy on Pain, Range of Motion and Functional Disability in Patients With Upper Cross Syndrome
A study testing Kinesio Taping Technique and Routine Physical Therapy in people with Cervical Pain, run by University of Lahore at 1 site in Pakistan.
Trial summary
Objective of the study is to compare the effects of kinesio taping and routine physical therapy on pain, range of motion and functional disability in patients with upper cross syndrome.It is a single blinded randomized controlled trial using non probability purposive sampling technique. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Kinesio Taping Technique and Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Nov 2021to 5 Feb 2022
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender
- Participants with an age between 18 to 40
- Participants diagnosed with chronic upper cross syndrome by orthopedic department for physical therapy treatment
Who cannot join
- Trauma, Tumor and Fracture of upper limb and shoulder
- Congenital deformities of upper limb
- History of any systemic disease
- History of any neurological disease (epilepsy \&seizure, Parkinson's disease)
- History of recent surgery of spine or shoulder
Trial locations and contacts
1 site in 1 country.
About this study
Objective of the study is to compare the effects of kinesio taping and routine physical therapy on pain, range of motion and functional disability in patients with upper cross syndrome.It is a single blinded randomized controlled trial using non probability purposive sampling technique.
ALTERNATIVE HYPOTHESIS:
Read more
There is a significant difference in the effects of routine physical therapy with and without kinesio taping on pain, range of motion and functional disability in patients with upper cross syndrome.
NULL HYPOTHESIS:
There is no significant difference in the effects of routine physical therapy with and without kinesio taping on pain, range of motion and functional disability in patients with upper cross syndrome.
Read the detailed description
It will be a prospectively registered ,parallel designed, randomized controlled trial with concealed allocation. Subjects will be selected from the outpatient Department of Physical Therapy, The University of Lahore Teaching Hospital,Lahore, Pakistan. Patients who met eligibility criteria will be informed about the aim of study.all the eligible participants who will agree to participate will sign a consent form. After baseline assessment selected participants will be divided into 2 groups by random allocation method.Subjects will be randomized into two groups using computer generated random numbers.The outcome assessor will be unaware of treatment given to both groups.The calculated sample size using Numeric pain rating scale as outcome measure is 28 in each group, but after adding 20% dropout, the sample size will be 28+6=34 in each group, allowing statistical power of 80%and alpha level of 5%.
- Conditions
- Cervical Pain
- Being tested
- Kinesio Taping Technique, Routine Physical Therapy
- Keywords
- Upper Cross Syndrome, kinesio taping, Neck disability index, goniometer, pain
- Medical subject headings
- Neck Pain, Oculocerebral hypopigmentation syndrome type Preus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio Taping TechniqueOther
Kinesio taping is a thin, stretchy, elastic cotton strip with an acrylic adhesive that is approximately the same thickness as the epidermis of the skin. When the taping method is followed correctly, the tape effects on the muscle by facilitating a weakened muscle or relaxing an over-used muscle,decreasing pain, fatigue and increasing tissue recovery. Kinesio Taping facilitation technique will be used with fifty percent stretch on rhomboids bilaterally.
Routine Physical TherapyOther
routine physical therapy includes thermotherapy and Transcutaneous electrical nerve stimulation (TENS), the strengthening exercises of lower and middle trapezius, rhomboids and deep neck flexors. Stretching exercises of upper trapezius, pectoralis major and minor. Mobilization of cervicothoracic junction and postural education.
Thermotherapy and transcutaneous electrical nerve stimulation will be used for 10 minutes in each session. Each exercise will be performed in 3 sets of 10 repetitions. Treatment session will have a duration of 30-45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group A/ kinesio taping group | Experimental | Routine physical therapy along with Kinesio Taping Receives: Other: Kinesio Taping Technique; Other: Routine Physical Therapy |
| Group B/ routine physical therapy | Active comparator | routine physical therapy Receives: Other: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale( assessing change in pain at between baseline, at 1st week, 2nd week and at the end of 4th week of treatment)
This is 11 points scale ranges from 0-10, where 0 means no pain and 10 is the worst pain. The values ranges from 1-3 means mild pain; 4-6 is considered moderate pain; 7-10 is severe pain. the average of three readings is considered as pain value.
Measured: baseline, 1st week ,2nd week and 4th week
Universal Goniometer (to assess change in range of motion at baseline,1st,2nd and 4th week.)
A universal goniometer is a device that measures an angle or permits rotation of an object to a definite position. It is designed like a protractor and may form a full or a half-circle from 0 to 180 degrees or 180 to 0 degrees for half circle models or 0 to 360 degrees on full circle.Normal range of motion of flexion 0-45 ₒ extension, 0-45 ₒ, side flexion 0-45 ₒ , rotation 0-80.
Measured: baseline, 1st week ,2nd week and 4th week
Neck disability Index ( assessing change in neck functional activities at baseline, 1st,2nd and 4th week)
This is the Patient-completed, condition-specific functional status questionnaire with 10 items for measuring disability in patients with neck pain.It contains 10 pain-related questions scored from 0 (no pain) to 5 (most severe pain).
Measured: baseline, 1st,2nd and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start24 Nov 2021
- Primary completion5 Feb 2022
- Study completion5 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sobia Ghafoor, MSPT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191043
- Sponsor's protocol ID
- IRB-UOL-FAHS/998/2021
- Status last verified
- Feb 2022
- First submitted
- 29 Dec 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio Taping in Addition to Routine Physical Therapy on Pain, Range of Motion and Functional Disability in Patients With Upper Cross Syndrome
- ClinicalTrials.gov ID
- NCT05191043
- Acronym / sponsor ID
- IRB-UOL-FAHS/998/2021
- Conditions
- Cervical Pain
- Keywords
- Upper Cross Syndrome, kinesio taping, Neck disability index, goniometer, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 5 Feb 2022 (actual)
- Study completion
- 5 Feb 2022 (actual)
- First posted
- 13 Jan 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.
Objective of the study is to compare the effects of kinesio taping and routine physical therapy on pain, range of motion and functional disability in patients with upper cross syndrome.It is a single blinded randomized controlled trial using non probability purposive sampling technique.
ALTERNATIVE HYPOTHESIS:
There is a significant difference in the effects of routine physical therapy with and without kinesio taping on pain, range of motion and functional disability in patients with upper cross syndrome.
NULL HYPOTHESIS:
There is no significant difference in the effects of routine physical therapy with and without kinesio taping on pain, range of motion and functional disability in patients with upper cross syndrome.
Detailed description
It will be a prospectively registered ,parallel designed, randomized controlled trial with concealed allocation. Subjects will be selected from the outpatient Department of Physical Therapy, The University of Lahore Teaching Hospital,Lahore, Pakistan. Patients who met eligibility criteria will be informed about the aim of study.all the eligible participants who will agree to participate will sign a consent form. After baseline assessment selected participants will be divided into 2 groups by random allocation method.Subjects will be randomized into two groups using computer generated random numbers.The outcome assessor will be unaware of treatment given to both groups.The calculated sample size using Numeric pain rating scale as outcome measure is 28 in each group, but after adding 20% dropout, the sample size will be 28+6=34 in each group, allowing statistical power of 80%and alpha level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A/ kinesio taping group | Experimental | Other: Kinesio Taping Technique, Other: Routine Physical TherapyRoutine physical therapy along with Kinesio Taping |
| Group B/ routine physical therapy | Active comparator | Other: Routine Physical Therapyroutine physical therapy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both gender
- Participants with an age between 18 to 40
- Participants diagnosed with chronic upper cross syndrome by orthopedic department for physical therapy treatment
Key exclusion criteria (5 listed)
- Trauma, Tumor and Fracture of upper limb and shoulder
- Congenital deformities of upper limb
- History of any systemic disease
- History of any neurological disease (epilepsy \&seizure, Parkinson's disease)
- History of recent surgery of spine or shoulder
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 Taping TechniqueKinesio taping is a thin, stretchy, elastic cotton strip with an acrylic adhesive that is approximately the same thickness as the epidermis of the skin. When the taping method is followed correctly, the tape effects on the muscle by facilitating a weakened muscle or relaxing an over-used muscle,decreasing pain, fatigue and increasing tissue recovery. Kinesio Taping facilitation technique will be used with fifty percent stretch on rhomboids bilaterally. | Other | Group A/ kinesio taping group |
| Routine Physical Therapyroutine physical therapy includes thermotherapy and Transcutaneous electrical nerve stimulation (TENS), the strengthening exercises of lower and middle trapezius, rhomboids and deep neck flexors. Stretching exercises of upper trapezius, pectoralis major and minor. Mobilization of cervicothoracic junction and postural education. Thermotherapy and transcutaneous electrical nerve stimulation will be used for 10 minutes in each session. Each exercise will be performed in 3 sets of 10 repetitions. Treatment session will have a duration of 30-45 minutes. | Other | Group A/ kinesio taping group, Group B/ routine physical therapy |
Primary outcome
Numeric pain rating scale( assessing change in pain at between baseline, at 1st week, 2nd week and at the end of 4th week of treatment)
Time frame: baseline, 1st week ,2nd week and 4th week
This is 11 points scale ranges from 0-10, where 0 means no pain and 10 is the worst pain. The values ranges from 1-3 means mild pain; 4-6 is considered moderate pain; 7-10 is severe pain. the average of three readings is considered as pain value.
Universal Goniometer (to assess change in range of motion at baseline,1st,2nd and 4th week.)
Time frame: baseline, 1st week ,2nd week and 4th week
A universal goniometer is a device that measures an angle or permits rotation of an object to a definite position. It is designed like a protractor and may form a full or a half-circle from 0 to 180 degrees or 180 to 0 degrees for half circle models or 0 to 360 degrees on full circle.Normal range of motion of flexion 0-45 ₒ extension, 0-45 ₒ, side flexion 0-45 ₒ , rotation 0-80.
Neck disability Index ( assessing change in neck functional activities at baseline, 1st,2nd and 4th week)
Time frame: baseline, 1st,2nd and 4th week
This is the Patient-completed, condition-specific functional status questionnaire with 10 items for measuring disability in patients with neck pain.It contains 10 pain-related questions scored from 0 (no pain) to 5 (most severe pain).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Sobia Ghafoor, MSPT principal investigator
University of Lahore
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 Taping Technique and Routine Physical Therapy in people with Cervical Pain, run by University of Lahore 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 3 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: finished, as of the sponsor's last update on 8 Feb 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numeric pain rating scale( assessing change in pain at between baseline, at 1st week, 2nd week and at the end of 4th week of treatment) (time frame: baseline, 1st week ,2nd week and 4th week). 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 8 Feb 2022.