Neck PainNCT04184024
A Comparison of the Effectiveness of Massage and Kinesio Taping in Neck Pain
A study testing Massage, Kinesio tape and Neck stabilization exercise in people with Neck Pain, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the effectiveness of massage and Kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Massage, Kinesio tape and Neck stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 20 Mar 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age,
- having generalized neck pain for more than 3 months,
- being volunteer
Who cannot join
- pregnancy,
- inflammatory rheumatologic diseases,
- malignity,
- structural deformity,
- previous surgery related to the cervical spine,
- cervical spinal stenosis,
Show all 9Show fewer
- being allergic to Kinesio tape
- severe psychological disorder,
- any intervention that included exercise or physical therapy in the last 3 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yildirim Beyazit University
Ankara, 06760
Seyda Toprak Çelenay
About this study
Official title: A Comparison of the Effectiveness of Massage and Kinesio Taping on Pain, Range of Motion, Disability and Quality of Life in Patients With Chronic Neck Pain
This study aimed to compare the effectiveness of massage and Kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain.
Read the detailed description
Neck pain is a common condition, affecting 30% to 50% of the general population, and is most prevalent in middle age.33 It is usually accompanied by a substantial effect on daily life, resulting in an extensive use of health care resources.
Several physical therapy applications such as massage therapy, kinesio taping, thermal and electrophysiological agents, hydrotherapy/spa therapy, and therapeutic exercises especially neck stabilization exercise are used to manage FM. Both massage therapy and kinesio taping have a favorable effect on clinical symptoms. However, it is not clear which method is more effective. Therefore, this study aimed to compare the effectiveness of massage and Kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain.
- Conditions
- Neck Pain
- Being tested
- Massage, Kinesio tape, Neck stabilization exercise
- Keywords
- neck pain, massage, kinesio tape,
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
Soft tissue massage known as "Swedish massage" technique was applied to the neck area for 20 minutes. This massage was carried out 3 days a week for 4 weeks (12 sessions) by the supervisor physiotherapist.
Kinesio tapeOther
Patients were taped according to the Kenzo Kase's Kinesio Taping Method by an experienced physical therapist. The application was carried out in a relaxed sitting position. Y banding with extensor muscles on the back of the neck with muscle technique, I banding with the upper trapezius with muscle technique and I banding with ligament technique to the middle region of the neck were performed.
Neck stabilization exerciseOther
Neck stabilization exercise was performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program started with postural training and then the cervical bracing technique with the activation of deep neck flexors for NSE was performed. The patients were asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises were increased weekly. It was carried out 3 days a week for 4 weeks (12 sessions) by the supervisor physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Massage group | Active comparator | Patients in this group were applied to massage plus neck stabilization exercise. Receives: Other: Massage; Other: Neck stabilization exercise |
| Kinesio taping group | Active comparator | Patients in this group were applied to Kinesio taping plus neck stabilization exercise. Receives: Other: Kinesio tape; Other: Neck stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level (Visual Analog Scale)
The pain level was assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants are asked to mark the intensity of their pain level.
Measured: change from baseline at 4 weeks
Secondary outcomes (3)
Turkish of the Short Form-36
The quality of life was assessed with the Turkish of the Short Form-36 (SF-36). The SF-36 consists of 36 questions: physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), social functioning (2 items), vitality (4 items), role limitations due to emotional health (3 items), mental health (5 items), general health perceptions (5 items) and changes in health over time (1 item, not included in the final score). The SF-36 score ranges from 0 (the worst score) to 100 (the best score). Thus, higher scores indicate better health. The participants are asked to fulfill the questionnaire.
Measured: change from baseline at 4 weeks
Turkish version of Neck Disability Index
The disability level was measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients were asked to select the most appropriate option for each section.
Measured: change from baseline at 4 weeks
Range of Motion
The range of motion of the neck joints of the patients was measured with a clinical goniometer (Baseline Evaluation Tools, USA) for flexion, extension, lateral flexion and rotation movements while sitting upright on the stool.
Measured: change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Nov 2018
- Primary completion1 Mar 2020 (estimated)
- Study completion20 Mar 2020 (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.
- 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- seyda toprak celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184024
- Sponsor's protocol ID
- 2017/10/03
- Status last verified
- Nov 2019
- First submitted
- 30 Nov 2019
- Last updated
- 3 Dec 2019
- 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 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of Massage and Kinesio Taping on Pain, Range of Motion, Disability and Quality of Life in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04184024
- Acronym / sponsor ID
- 2017/10/03
- Conditions
- Neck Pain
- Keywords
- neck pain, massage, kinesio tape,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 20 Mar 2020 (estimated)
- First posted
- 3 Dec 2019 (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 aimed to compare the effectiveness of massage and Kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain.
Detailed description
Neck pain is a common condition, affecting 30% to 50% of the general population, and is most prevalent in middle age.33 It is usually accompanied by a substantial effect on daily life, resulting in an extensive use of health care resources.
Several physical therapy applications such as massage therapy, kinesio taping, thermal and electrophysiological agents, hydrotherapy/spa therapy, and therapeutic exercises especially neck stabilization exercise are used to manage FM. Both massage therapy and kinesio taping have a favorable effect on clinical symptoms. However, it is not clear which method is more effective. Therefore, this study aimed to compare the effectiveness of massage and Kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage group | Active comparator | Other: Massage, Other: Neck stabilization exercisePatients in this group were applied to massage plus neck stabilization exercise. |
| Kinesio taping group | Active comparator | Other: Kinesio tape, Other: Neck stabilization exercisePatients in this group were applied to Kinesio taping plus neck stabilization exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years of age,
- having generalized neck pain for more than 3 months,
- being volunteer
Key exclusion criteria (9 listed)
- pregnancy,
- inflammatory rheumatologic diseases,
- malignity,
- structural deformity,
- previous surgery related to the cervical spine,
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 |
|---|---|---|
| MassageSoft tissue massage known as "Swedish massage" technique was applied to the neck area for 20 minutes. This massage was carried out 3 days a week for 4 weeks (12 sessions) by the supervisor physiotherapist. | Other | Massage group |
| Kinesio tapePatients were taped according to the Kenzo Kase's Kinesio Taping Method by an experienced physical therapist. The application was carried out in a relaxed sitting position. Y banding with extensor muscles on the back of the neck with muscle technique, I banding with the upper trapezius with muscle technique and I banding with ligament technique to the middle region of the neck were performed. | Other | Kinesio taping group |
| Neck stabilization exerciseNeck stabilization exercise was performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program started with postural training and then the cervical bracing technique with the activation of deep neck flexors for NSE was performed. The patients were asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises were increased weekly. It was carried out 3 days a week for 4 weeks (12 sessions) by the supervisor physiotherapist. | Other | Kinesio taping group, Massage group |
Primary outcome
Pain Level (Visual Analog Scale)
Time frame: change from baseline at 4 weeks
The pain level was assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants are asked to mark the intensity of their pain level.
3 secondary outcomes
Turkish of the Short Form-36
Time frame: change from baseline at 4 weeks
Turkish version of Neck Disability Index
Time frame: change from baseline at 4 weeks
Range of Motion
Time frame: change from baseline at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- 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.
seyda toprak celenay principal investigator
Ankara Yildirim Beyazıt 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 Massage, Kinesio tape and Neck stabilization exercise in people with Neck Pain, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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: status not confirmed, as of the sponsor's last update on 3 Dec 2019. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact seyda toprak celenay, PT (+90-534-041-3986, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (Visual Analog Scale) (time frame: change from baseline at 4 weeks). 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 3 Dec 2019.