HeadacheNCT05474612
Comparison of Kinesiology Taping and Instrument Assisted Soft Tissue Mobilization in Cervicogenic Headache
A study testing kinesiology taping with conventional therapy and Instrument assisted soft tissue mobilization with conventional therapy in people with Headache and Cervical Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of kinesiology taping and Instrument Assisted Soft Tissue Mobilization in cervicogenic headache Read more about this study
- Who is it for?
- Ages 30 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Cervical Pain
- What is being tested?
- kinesiology taping with conventional therapy and Instrument assisted soft tissue mobilization with conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Nov 2021to 15 Jul 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 30 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically diagnosed cervicogenic headache patients.
- Headache with neck stiffness and pain
- Positive flexion rotation test with restriction 6-10 degree.
- Unilateral headache with referred pattern
- Age between 30-44 years
- Both males and females
Who cannot join
- Head and neck surgery
- Congenital deformity
- Erosive bone diseases
- Obese
- Disc pathologies
- Malignancy and infection of neck region
Show all 9Show fewer
- Osteoarthritis
- Rheumatoid arthritis
- Dislocation of vertebraes
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 46010
About this study
To compare the effects of kinesiology taping and Instrument Assisted Soft Tissue Mobilization in cervicogenic headache
Read the detailed description
Cervicogenic headache (CGH) is a clinical syndrome characterized by primarily unilateral pain that originates in the neck, typically provoked by neck movement or pressure over tender points in the neck, with reduced range of movement of the cervical spine . It is characterized by unilateral headache with signs and symptoms of neck involvement, such as, pain by movement, by external pressure over the upper cervical, and/or sustained awkward head positions . Functional impairments (diminished strength and endurance) in the cervical muscles and poorer muscle control of the deep cervical flexors have been shown in patients with cervicogenic headache . The International Headache Society (IHS) has declared CGH as a secondary type of headache.The main cause of CGH is dysfunction in the upper cervical spine, and the mechanism of headache involves nociceptive structures such as the disks, upper cervical spinal nerves, facet joints, ganglia, muscles, and ligaments , pain most commonly arises from the second and third cervical spine (C2/3) facet joints, followed by C5/6 facet joints This sign and symptoms are described as the pain being unilateral or bilateral, affecting the head or face but has most commonly affected the occipital region, frontal region, or retro-orbital region, commonly associated with suboccipital neck pain, but can also be associated with ipsilateral arm discomfort. Other symptoms associated with CGH include dizziness, nausea, lightheadedness, inability to concentrate, retro-ocular pain, and visual disturbances.
- Conditions
- Headache, Cervical Pain
- Being tested
- kinesiology taping with conventional therapy, Instrument assisted soft tissue mobilization with conventional therapy
- Keywords
- Cervicogenic Headache, Instrument Assisted Soft Tissue Mobilization, Kinesiology taping, Cervical range of motion, Neck disability index, Numeric pain rating scale
- Medical subject headings
- Headache, Neck Pain, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiology taping with conventional therapyOther
Two pieces of the tape cutted in a Y-shape. Applied on deep cervical extensors and upper fibers of trapezius. Length of the tape may vary from person to person. Patient is instructed to keep the tape for at-least 2 days.
Instrument assisted soft tissue mobilization with conventional therapyOther
IASTM using tools over the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes. Participants are in a comfortable position during treatment.
| Study group | Role | What they receive |
|---|---|---|
| kinesiology taping with conventional therapy | Experimental | Patients in group A is treated with conventional treatment (include stretching exercises of SCM, Scaleni and upper fibers of trapezius followed by strengthening (isometrics) of Neck flexors (SCM, rectus capitis, anterior and longus capitis) and then with kinesiology taping.
Two pieces of the tape cutted in a Y-shape. Applied on deep cervical extensors and upper fibers of trapezius. Receives: Other: kinesiology taping with conventional therapy |
| Instrument Assisted Soft Tissue Mobilization with Conventional therapy | Active comparator | Patients in group B is treated with conventional treatment (stretching exercises of SCM, Scaleni and upper fibers of trapezius followed by strengthening (isometrics) of Neck flexors (SCM, rectus capitis, anterior and longus capitis) and then with Instrument Assisted soft tissue mobilization technique.
IASTM using tools over the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes. Receives: Other: Instrument assisted soft tissue mobilization with conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Changes from baseline Numeric pain Rating Scale is used to objectively assess musculoskeletal pain as marked by the patient. It is a 10 point scale from 0 to 10. 0 depicts no pain at all and 10 shows worst pain ever felt. It is measured at baseline and after 4 weeks of the intervention
Measured: 4th week
Secondary outcomes (1)
Neck disability index
Changes from baseline NDI is the most widely used instrument for assessing self-rated disability in patients with neck pain. The NDI is a self-report questionnaire with 10-items. The response to each item is rated on a 6-point scale from 0 (no disability) to 5 (complete disability). The numeric responses for each item are summed for a total score ranging between 0 and 50. Most of the subjects did not know how to drive so their total score is taken from 45. The questionnaire is filled by the subjects at basline and after 4 weeks of the intervention
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start25 Nov 2021
- Primary completion5 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- 36 participants were recruited in study and divided into two groups. Group A is given intervention with kinesiology taping and group B is given Instrument Assisted Soft Tissue Mobilization treatment.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474612
- Sponsor's protocol ID
- Riphah/RCRS/REC/01218
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Kinesiology Taping and Instrument Assisted Soft Tissue Mobilization in Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05474612
- Acronym / sponsor ID
- Riphah/RCRS/REC/01218
- Conditions
- Headache, Cervical Pain
- Keywords
- Cervicogenic Headache, Instrument Assisted Soft Tissue Mobilization, Kinesiology taping, Cervical range of motion, Neck disability index, Numeric pain rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 26 Jul 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.
To compare the effects of kinesiology taping and Instrument Assisted Soft Tissue Mobilization in cervicogenic headache
Detailed description
Cervicogenic headache (CGH) is a clinical syndrome characterized by primarily unilateral pain that originates in the neck, typically provoked by neck movement or pressure over tender points in the neck, with reduced range of movement of the cervical spine . It is characterized by unilateral headache with signs and symptoms of neck involvement, such as, pain by movement, by external pressure over the upper cervical, and/or sustained awkward head positions . Functional impairments (diminished strength and endurance) in the cervical muscles and poorer muscle control of the deep cervical flexors have been shown in patients with cervicogenic headache . The International Headache Society (IHS) has declared CGH as a secondary type of headache.The main cause of CGH is dysfunction in the upper cervical spine, and the mechanism of headache involves nociceptive structures such as the disks, upper cervical spinal nerves, facet joints, ganglia, muscles, and ligaments , pain most commonly arises from the second and third cervical spine (C2/3) facet joints, followed by C5/6 facet joints This sign and symptoms are described as the pain being unilateral or bilateral, affecting the head or face but has most commonly affected the occipital region, frontal region, or retro-orbital region, commonly associated with suboccipital neck pain, but can also be associated with ipsilateral arm discomfort. Other symptoms associated with CGH include dizziness, nausea, lightheadedness, inability to concentrate, retro-ocular pain, and visual disturbances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 36 participants were recruited in study and divided into two groups. Group A is given intervention with kinesiology taping and group B is given Instrument Assisted Soft Tissue Mobilization treatment.
| Arm | Type | Receives |
|---|---|---|
| kinesiology taping with conventional therapy | Experimental | Other: kinesiology taping with conventional therapyPatients in group A is treated with conventional treatment (include stretching exercises of SCM, Scaleni and upper fibers of trapezius followed by strengthening (isometrics) of Neck flexors (SCM, rectus capitis, anterior and longus capitis) and then with kinesiology taping. Two pieces of the tape cutted in a Y-shape. Applied on deep cervical extensors and upper fibers of trapezius. |
| Instrument Assisted Soft Tissue Mobilization with Conventional therapy | Active comparator | Other: Instrument assisted soft tissue mobilization with conventional therapyPatients in group B is treated with conventional treatment (stretching exercises of SCM, Scaleni and upper fibers of trapezius followed by strengthening (isometrics) of Neck flexors (SCM, rectus capitis, anterior and longus capitis) and then with Instrument Assisted soft tissue mobilization technique. IASTM using tools over the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes. |
Who may qualify
- Ages
- 30 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinically diagnosed cervicogenic headache patients.
- Headache with neck stiffness and pain
- Positive flexion rotation test with restriction 6-10 degree.
- Unilateral headache with referred pattern
- Age between 30-44 years
Key exclusion criteria (9 listed)
- Head and neck surgery
- Congenital deformity
- Erosive bone diseases
- Obese
- Disc pathologies
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 |
|---|---|---|
| kinesiology taping with conventional therapyTwo pieces of the tape cutted in a Y-shape. Applied on deep cervical extensors and upper fibers of trapezius. Length of the tape may vary from person to person. Patient is instructed to keep the tape for at-least 2 days. | Other | kinesiology taping with conventional therapy |
| Instrument assisted soft tissue mobilization with conventional therapyIASTM using tools over the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes. Participants are in a comfortable position during treatment. | Other | Instrument Assisted Soft Tissue Mobilization with Conventional therapy |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4th week
Changes from baseline Numeric pain Rating Scale is used to objectively assess musculoskeletal pain as marked by the patient. It is a 10 point scale from 0 to 10. 0 depicts no pain at all and 10 shows worst pain ever felt. It is measured at baseline and after 4 weeks of the intervention
1 secondary outcome
Neck disability index
Time frame: 4th week
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 26 Jul 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.
Muhammad Affan Iqbal, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesiology taping with conventional therapy and Instrument assisted soft tissue mobilization with conventional therapy in people with Headache and Cervical Pain, run by Riphah International University 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 6 inclusion and 9 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 26 Jul 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 (time frame: 4th week). 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 26 Jul 2022.