Neck PainNCT04882397
Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Chronic Neck Pain
A study testing Instrument Assisted Soft Tissue Mobilization in people with Neck Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Chronic neck pain causes errors in joint position. There are studies in the literature suggesting that the application of instrument-assisted soft tissue mobilization improves the sense of joint position. There are no studies that acutely examine this practice on joint position sense and pain in the cervical region. 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?
- Instrument Assisted Soft Tissue Mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2021to 20 Jul 2021
- 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
- • Being diagnosed with chronic neck pain,
- To be in the age range of 18-65.
Who cannot join
- • Those taking any analgesic medication
- Those with acute injury or infection,
- Those with open wounds, Osteoporosis,
- Broken,
- Hematoma, Those with acute cardiac, liver and kidney problems,
- Those with connective tissue disease, Rheumatoid arthritis, osteoarthritis, Cancer,
- Those with circulation problems,
- Those with peripheral vascular disease, Epilepsy, Surgery history in the cervical area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Pain and Joint Position Sense in Individuals With Chronic Neck Pain
Chronic neck pain causes errors in joint position. There are studies in the literature suggesting that the application of instrument-assisted soft tissue mobilization improves the sense of joint position. There are no studies that acutely examine this practice on joint position sense and pain in the cervical region. As a result of our study, we will investigate the effects of instrument-assisted soft tissue mobilization in a single session on perception of pain and joint position.
- Conditions
- Neck Pain
- Being tested
- Instrument Assisted Soft Tissue Mobilization, Sham
- Keywords
- Joint Position Sense, Soft Tissue, Mobilization, Neck Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationOther
Bilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
ShamOther
Bilateral sham Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
| Study group | Role | What they receive |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | In the application group, Instrument Assisted Soft Tissue Mobilization will be applied to the Trapezius and Sternocleideomastoideus muscles for 90 seconds. Receives: Other: Instrument Assisted Soft Tissue Mobilization |
| Sham Instrument Assisted Soft Tissue Mobilization | Sham comparator | In the sham application group, 90 degrees to 90 seconds will be applied to the Trapezius and Sternocleideomastoideus muscles without applying pressure. Receives: Other: Sham |
| Control | No intervention | No application will be made to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Cervical Pain at 2 minutes
Pain will be evaluated with Visual Analog Scale.
Measured: Baseline and 2 minutes after intervention
Change from Baseline Joint Position Sense at 2 minutes
Joint Position Sense will be evaluated Cervical Range of Motion Device
Measured: Baseline and 2 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start26 Jun 2021
- Primary completion26 Jun 2021
- Study completion20 Jul 2021
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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882397
- Sponsor's protocol ID
- KaratayUH3
- Status last verified
- May 2021
- First submitted
- 8 May 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gercek H, Unuvar BS, Umit Yemisci O, Aytar A. Acute effects of instrument assisted soft tissue mobilization technique on pain and joint position error in individuals with chronic neck pain: a double-blind, randomized controlled trial. Somatosens Mot Res. 2023 Mar;40(1):25-32. doi: 10.1080/08990220.2022.2157388. Epub 2022 Dec 20.
PubMed 36538383
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Pain and Joint Position Sense in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04882397
- Acronym / sponsor ID
- KaratayUH3
- Conditions
- Neck Pain
- Keywords
- Joint Position Sense, Soft Tissue, Mobilization, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 12 May 2021 (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.
Chronic neck pain causes errors in joint position. There are studies in the literature suggesting that the application of instrument-assisted soft tissue mobilization improves the sense of joint position. There are no studies that acutely examine this practice on joint position sense and pain in the cervical region. As a result of our study, we will investigate the effects of instrument-assisted soft tissue mobilization in a single session on perception of pain and joint position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | Other: Instrument Assisted Soft Tissue MobilizationIn the application group, Instrument Assisted Soft Tissue Mobilization will be applied to the Trapezius and Sternocleideomastoideus muscles for 90 seconds. |
| Sham Instrument Assisted Soft Tissue Mobilization | Sham comparator | Other: ShamIn the sham application group, 90 degrees to 90 seconds will be applied to the Trapezius and Sternocleideomastoideus muscles without applying pressure. |
| Control | No intervention | –No application will be made to the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Being diagnosed with chronic neck pain,
Key exclusion criteria (8 listed)
- • Those taking any analgesic medication
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 |
|---|---|---|
| Instrument Assisted Soft Tissue MobilizationBilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles. | Other | Instrument Assisted Soft Tissue Mobilization |
| ShamBilateral sham Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles. | Other | Sham Instrument Assisted Soft Tissue Mobilization |
Primary outcome
Change from Baseline Cervical Pain at 2 minutes
Time frame: Baseline and 2 minutes after intervention
Pain will be evaluated with Visual Analog Scale.
Change from Baseline Joint Position Sense at 2 minutes
Time frame: Baseline and 2 minutes after intervention
Joint Position Sense will be evaluated Cervical Range of Motion Device
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 Jul 2022.
- Derived from this study: PubMed 36538383Gercek H, Unuvar BS, Umit Yemisci O, Aytar A. Acute effects of instrument assisted soft tissue mobilization technique on pain and joint position error in individuals with chronic neck pain: a double-blind, randomized controlled trial. Somatosens Mot Res. 2023 Mar;40(1):25-32. doi: 10.1080/08990220.2022.2157388. Epub 2022 Dec 20.
- Individual participant dataSharing planned: Undecided
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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 Instrument Assisted Soft Tissue Mobilization in people with Neck Pain, run by KTO Karatay 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 2 inclusion and 8 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 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 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. Some participants in this study may receive a placebo. 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?
Change from Baseline Cervical Pain at 2 minutes (time frame: Baseline and 2 minutes after intervention). The study lists 2 primary outcomes in all. 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 NCT04882397, 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 8 Jul 2022.