Neck Pain MusculoskeletalNCT06671860
The Effects Of Oculomotor Exercises And Hands-On Protocol In Non-Specific Neck Pain
A study testing Exercise in people with Neck Pain Musculoskeletal, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effectiveness of adding oculomotor techniques and hands-on treatments to routine exercise protocols for individuals with non-specific chronic neck pain (NSCNP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain Musculoskeletal
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2023to 22 Nov 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria included being between ages 18 and 65 old, having been diagnosed with nonspecific neck pain, being able to comply with exercise instructions and understand evaluation questions, and volunteering to participate in the research.
Who cannot join
- History of acute or chronic musculoskeletal pain other than nonspecific neck pain, history of a rheumatological disease, sequestered or extruded disc herniation, having received physical therapy in the last three months, recent history of surgery, infectious and vascular diseases, and cooperation and communication problems presence were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yeditepe university
Istanbul, 34758
nilüfer cerbezer, 05413468854, niluferrklc@gmail.com
About this study
Official title: Investigation Of The Effects Of Oculomotor Exercises And Hands-On Protocol In Patients With Non-Specific Neck Pain
This study aimed to evaluate the effectiveness of adding oculomotor techniques and hands-on treatments to routine exercise protocols for individuals with non-specific chronic neck pain (NSCNP).
Read the detailed description
A randomized controlled trial was performed at the orthopedic rehabilitation clinic. Ethical Standards in the 1946 Declaration of Helsinki, as revised in 2013, were followed, and the University Ethics Board approved the study (approval number 147). This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The study was conducted with individuals aged 18-65 who applied to a private clinic, received a doctor's diagnosis, met the inclusion criteria, and voluntarily agreed to participate in the study.
Participants A total of 38 subjects were calculated as the minimum required sample size determined by power analysis, and 38 subjects aged 18 to 65 years with a diagnosis of nonspecific neck pain who met the inclusion criteria and voluntarily agreed to participate were included in the study. Signed consent forms were obtained from the volunteers who agreed to participate in the study by face-to-face interview.
- Conditions
- Neck Pain Musculoskeletal
- Being tested
- Exercise
- Keywords
- neck, non-specific neck pain, exercise, oculomotor exercises, myofascial release
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Individuals were randomly assigned to the REP (Routine Exercise Program) group and the OHP group. The REP group received the traditional exercise protocol and the OHP group received oculomotor exercises and myofascial release techniques in addition to the traditional exercise. The groups were evaluated before the treatment and at the end of the 6-week treatment sessions. Patient education was given to the patients before both programs. Patient education included information about nonspecific chronic neck pain, symptoms, and complications, as well as assessment methods, parameters, tests, and exercises.
The first group, the REP group (n=19), received routine exercises, and the second group, the OHP group (n=19), received oculomotor exercises and myofascial relaxation techniques in addition to the routine exercise program. The treatments were applied for six weeks, three sessions per week, under the supervision and guidance of a physiotherapist in the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Routine Exercise Group The routine exercise program included the following exercises: chin stretchin | Experimental | Not described Receives: Other: Exercise |
| Oculomotor Exercise Group The oculomotor exercise program consisted of a series of activities such a | Active comparator | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity was measured with a visual analog scale (VAS).
Measured: 6 week
Secondary outcomes (1)
Proprioception
joint position sense (JPS) was assessed using a laser pointer.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start10 Jun 2023
- Primary completion30 Sep 2023
- Study completion22 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck Pain MusculoskeletalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671860
- Sponsor's protocol ID
- Yeditepe U4
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bier JD, Scholten-Peeters WGM, Staal JB, Pool J, van Tulder MW, Beekman E, Knoop J, Meerhoff G, Verhagen AP. Clinical Practice Guideline for Physical Therapy Assessment and Treatment in Patients With Nonspecific Neck Pain. Phys Ther. 2018 Mar 1;98(3):162-171. doi: 10.1093/ptj/pzx118.
PubMed 29228289
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Effects Of Oculomotor Exercises And Hands-On Protocol In Patients With Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT06671860
- Acronym / sponsor ID
- Yeditepe U4
- Conditions
- Neck Pain Musculoskeletal
- Keywords
- neck, non-specific neck pain, exercise, oculomotor exercises, myofascial release
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 22 Nov 2024 (estimated)
- First posted
- 4 Nov 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 aimed to evaluate the effectiveness of adding oculomotor techniques and hands-on treatments to routine exercise protocols for individuals with non-specific chronic neck pain (NSCNP).
Detailed description
A randomized controlled trial was performed at the orthopedic rehabilitation clinic. Ethical Standards in the 1946 Declaration of Helsinki, as revised in 2013, were followed, and the University Ethics Board approved the study (approval number 147). This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The study was conducted with individuals aged 18-65 who applied to a private clinic, received a doctor's diagnosis, met the inclusion criteria, and voluntarily agreed to participate in the study.
Participants A total of 38 subjects were calculated as the minimum required sample size determined by power analysis, and 38 subjects aged 18 to 65 years with a diagnosis of nonspecific neck pain who met the inclusion criteria and voluntarily agreed to participate were included in the study. Signed consent forms were obtained from the volunteers who agreed to participate in the study by face-to-face interview.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Exercise Group The routine exercise program included the following exercises: chin stretchin | Experimental | Other: Exercise |
| Oculomotor Exercise Group The oculomotor exercise program consisted of a series of activities such a | Active comparator | Other: Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria included being between ages 18 and 65 old, having been diagnosed with nonspecific neck pain, being able to comply with exercise instructions and understand evaluation questions, and volunteering to participate in the research.
Key exclusion criteria (1 listed)
- History of acute or chronic musculoskeletal pain other than nonspecific neck pain, history of a rheumatological disease, sequestered or extruded disc herniation, having received physical therapy in the last three months, recent history of surgery, infectious and vascular diseases, and cooperation and communication problems presence were excluded.
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 |
|---|---|---|
| ExerciseIndividuals were randomly assigned to the REP (Routine Exercise Program) group and the OHP group. The REP group received the traditional exercise protocol and the OHP group received oculomotor exercises and myofascial release techniques in addition to the traditional exercise. The groups were evaluated before the treatment and at the end of the 6-week treatment sessions. Patient education was given to the patients before both programs. Patient education included information about nonspecific chronic neck pain, symptoms, and complications, as well as assessment methods, parameters, tests, and exercises. The first group, the REP group (n=19), received routine exercises, and the second group, the OHP group (n=19), received oculomotor exercises and myofascial relaxation techniques in addition to the routine exercise program. The treatments were applied for six weeks, three sessions per week, under the supervision and guidance of a physiotherapist in the clinic. | Other | Oculomotor Exercise Group The oculomotor exercise program consisted of a series of activities such a, Routine Exercise Group The routine exercise program included the following exercises: chin stretchin |
Primary outcome
Pain intensity
Time frame: 6 week
Pain intensity was measured with a visual analog scale (VAS).
1 secondary outcome
Proprioception
Time frame: 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Results publication: PubMed 29228289Bier JD, Scholten-Peeters WGM, Staal JB, Pool J, van Tulder MW, Beekman E, Knoop J, Meerhoff G, Verhagen AP. Clinical Practice Guideline for Physical Therapy Assessment and Treatment in Patients With Nonspecific Neck Pain. Phys Ther. 2018 Mar 1;98(3):162-171. doi: 10.1093/ptj/pzx118.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Neck Pain Musculoskeletal, run by Yeditepe University 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 1 inclusion and 1 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 4 Nov 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 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 nilüfer cerbezer, phd (05413468854, niluferrklc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06671860, which also lists 1 linked publication.
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 4 Nov 2024.