Post Neck Dissection SurgeryNCT06598826
Graston Technique Versus Kinesio Taping on Myofascial Pain Syndrome After Neck Dissection Surgery
A study testing Graston technique (IASTM) and Kinesio taping in people with Post Neck Dissection Surgery, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to investigate the effect of Graston technique versus Kinesiotaping on myofascial pain syndrome after neck dissection surgery. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Post Neck Dissection Surgery
- What is being tested?
- Graston technique (IASTM) and Kinesio taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2024to 31 Jul 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subjects were selected according to the following criteria:
- The patient's ages ranged from 30 to 50 years participated in this study. Both genders participated in this study. All patients had a history of MPS at UTM from 3 to 5 months. All patients had moderate to severe pain (VAS score >4). Informed consent was obtained from every patient enrolled in the trial. All patients had myofascial pain syndrome after unilateral modified radical neck dissection surgery.
Who cannot join
- The potential participants were excluded if they meet one of the following criteria:
- A wound in the affected area A cervical disk lesion Myelopathy or radiculopathy Cervical spine fracture or spondylolisthesis Rheumatoid arthritis Epilepsy or any psychological disorders Contraindications to IASTM. Contraindications to Kinesiotaping. Coagulopathy. Hemophilia or other clotting disorders.
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to investigate the effect of Graston technique versus Kinesiotaping on myofascial pain syndrome after neck dissection surgery.
Read the detailed description
Fifty two patients from both genders who had cervical Myofascial pain syndrome following a neck dissection surgery participated in this Study. Their ages ranged from 30 to 50 years. They had been selected from the National Cancer Institute, Cairo University. They were assigned randomly into two groups (A) and (B), equal in number. Group (A) received Graston technique (IASTM), in addition to traditional treatment (range of motion exercises, stretching exercises and strengthening exercises) for 12 Sessions performed in a period of 4 weeks (three times weekly). While Group (B) Received kinesiotaping, in addition to traditional treatment (range of motion exercises, stretching exercises and strengthening exercises) for 8 sessions performed in a period of 4 weeks (twice weekly). Pressure pain threshold, visual analogue scale and cervical lateral flexion and rotation were measured pre and post 4 weeks of treatment.
- Conditions
- Post Neck Dissection Surgery
- Being tested
- Graston technique (IASTM), Kinesio taping
- Keywords
- Graston technique (IASTM), Kinesiotape, Myofascial pain syndrome
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graston technique (IASTM)Device
Also called Traditional treatment (ROM exercise, strengthening exercise, and stretching exercises)
Group A includes 26 patients post ND who received Graston technique (IASTM) , in additional to traditional treatment (ROM exercise, strengthening exercise, and stretching exercise) for 1 month
Kinesio tapingOther
Also called Traditional treatment (ROM exercise, strengthening exercise, and stretching exercises)
Group B includes 26 patients who received Kinesiotaping, in addition to traditional treatment (ROM exercise, strengthening exercise, and stretching exercises) for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Graston technique | Active comparator | This group received Graston technique (IASTM) , in additional to traditional treatment (ROM exercise, strengthening exercise, and stretching exercise) 3 times per week for 1 month Receives: Device: Graston technique (IASTM) |
| Kinesio taping | Active comparator | Group B includes 26 patients who received Kinesiotaping, in addition to traditional treatment (ROM exercise, strengthening exercise, and stretching exercises) 2 times per week for 1 month Receives: Other: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion (ROM) (cervicallateralflexion)
Universal Goniometer is a reliable instrument used to evaluate Range of motion in degrees
Measured: Pretreatment, post treatment ( after 4 weeks of treatment)
Range of motion (ROM) (cervical rotation)
Universal Goniometer is a reliable instrument used to evaluate Range of motion in degrees
Measured: Pretreatment, post treatment ( after 4 weeks of treatment)
Pressure pain threshold
Pressure Algometer with a spring is used. They maintain a peak force or pressure (KP (kilopond) = 10 N, Newton = 100 kPa (kilopascal)) until tared
Measured: Pretreatment, post treatment ( after 4 weeks of treatment)
Assessment of pain
Vasual Analogue Scale(VAS) is used technique for assessing pain intensity , a continuous scale with a vertical or horizontal line of 100 mm, from 0 to10, whose extremes are designated "no pain" and "worst imaginable pain" (0= no pain; 10= most painful imaginable pain).
Measured: Pretreatment, post treatment ( after 4 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 May 2024
- Primary completion12 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Neck Dissection SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Abd-Elfatah Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598826
- Sponsor's protocol ID
- 4648
- Status last verified
- Jul 2023
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graston Technique Versus Kinesio Taping on Myofascial Pain Syndrome After Neck Dissection Surgery
- ClinicalTrials.gov ID
- NCT06598826
- Acronym / sponsor ID
- 4648
- Conditions
- Post Neck Dissection Surgery
- Keywords
- Graston technique (IASTM), Kinesiotape, Myofascial pain syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 19 Sep 2024 (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.
This study was conducted to investigate the effect of Graston technique versus Kinesiotaping on myofascial pain syndrome after neck dissection surgery.
Detailed description
Fifty two patients from both genders who had cervical Myofascial pain syndrome following a neck dissection surgery participated in this Study. Their ages ranged from 30 to 50 years. They had been selected from the National Cancer Institute, Cairo University. They were assigned randomly into two groups (A) and (B), equal in number. Group (A) received Graston technique (IASTM), in addition to traditional treatment (range of motion exercises, stretching exercises and strengthening exercises) for 12 Sessions performed in a period of 4 weeks (three times weekly). While Group (B) Received kinesiotaping, in addition to traditional treatment (range of motion exercises, stretching exercises and strengthening exercises) for 8 sessions performed in a period of 4 weeks (twice weekly). Pressure pain threshold, visual analogue scale and cervical lateral flexion and rotation were measured pre and post 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graston technique | Active comparator | Device: Graston technique (IASTM)This group received Graston technique (IASTM) , in additional to traditional treatment (ROM exercise, strengthening exercise, and stretching exercise) 3 times per week for 1 month |
| Kinesio taping | Active comparator | Other: Kinesio tapingGroup B includes 26 patients who received Kinesiotaping, in addition to traditional treatment (ROM exercise, strengthening exercise, and stretching exercises) 2 times per week for 1 month |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The subjects were selected according to the following criteria:
- The patient's ages ranged from 30 to 50 years participated in this study. Both genders participated in this study. All patients had a history of MPS at UTM from 3 to 5 months. All patients had moderate to severe pain (VAS score >4). Informed consent was obtained from every patient enrolled in the trial. All patients had myofascial pain syndrome after unilateral modified radical neck dissection surgery.
Key exclusion criteria (2 listed)
- The potential participants were excluded if they meet one of the following criteria:
- A wound in the affected area A cervical disk lesion Myelopathy or radiculopathy Cervical spine fracture or spondylolisthesis Rheumatoid arthritis Epilepsy or any psychological disorders Contraindications to IASTM. Contraindications to Kinesiotaping. Coagulopathy. Hemophilia or other clotting disorders.
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 |
|---|---|---|
| Graston technique (IASTM)Also: Traditional treatment (ROM exercise, strengthening exercise, and stretching exercises)Group A includes 26 patients post ND who received Graston technique (IASTM) , in additional to traditional treatment (ROM exercise, strengthening exercise, and stretching exercise) for 1 month | Device | Graston technique |
| Kinesio tapingAlso: Traditional treatment (ROM exercise, strengthening exercise, and stretching exercises)Group B includes 26 patients who received Kinesiotaping, in addition to traditional treatment (ROM exercise, strengthening exercise, and stretching exercises) for 1 month | Other | Kinesio taping |
Primary outcome
Range of motion (ROM) (cervicallateralflexion)
Time frame: Pretreatment, post treatment ( after 4 weeks of treatment)
Universal Goniometer is a reliable instrument used to evaluate Range of motion in degrees
Range of motion (ROM) (cervical rotation)
Time frame: Pretreatment, post treatment ( after 4 weeks of treatment)
Universal Goniometer is a reliable instrument used to evaluate Range of motion in degrees
Pressure pain threshold
Time frame: Pretreatment, post treatment ( after 4 weeks of treatment)
Pressure Algometer with a spring is used. They maintain a peak force or pressure (KP (kilopond) = 10 N, Newton = 100 kPa (kilopascal)) until tared
Assessment of pain
Time frame: Pretreatment, post treatment ( after 4 weeks of treatment)
Vasual Analogue Scale(VAS) is used technique for assessing pain intensity , a continuous scale with a vertical or horizontal line of 100 mm, from 0 to10, whose extremes are designated "no pain" and "worst imaginable pain" (0= no pain; 10= most painful imaginable 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 19 Sep 2024.
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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 Graston technique (IASTM) and Kinesio taping in people with Post Neck Dissection Surgery, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 2 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 19 Sep 2024. 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 Egypt. 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?
Range of motion (ROM) (cervicallateralflexion) (time frame: Pretreatment, post treatment ( after 4 weeks of treatment)). The study lists 4 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 19 Sep 2024.