Mechanical Neck PainNCT03545880
Kinesiotaping and Post-dry Needling Soreness
A study testing Kinesiotaping in people with Mechanical Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Different therapeutic strategies targeting to decrease post-dry needling soreness need to be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Neck Pain
- What is being tested?
- Kinesiotaping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jun 2018to 8 Aug 2018
- 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
- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature
Who cannot join
- any contraindication to dry needling
- whiplash injury;
- previous cervical surgery;
- cervical radiculopathy or myelopathy;
- diagnosis of fibromyalgia syndrome;
- having undergone any therapy intervention for the neck are in the previous 6 months;
- fear to needles;
- less than 18 or greater than 65 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Kinesiotaping on Post-Needling Soreness by Dry Needling on Active Trigger Points
Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Different therapeutic strategies targeting to decrease post-dry needling soreness need to be investigated. Since Kinesiotaping has been advocated for decreasing tone in the muscle tissues, it would be a potential intervention for this objective.
- Conditions
- Mechanical Neck Pain
- Being tested
- Kinesiotaping, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
A Kinesiotaping will be provided over the upper trapezius muscle after the application of dry needling
PlaceboOther
Individuals will not perform any action after the application of trigger point dry needling
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping | Experimental | A Kinesiotaping will be provided over the upper trapezius muscle after the application of dry needling Receives: Other: Kinesiotaping |
| Placebo | Placebo comparator | Individuals will not perform any action after the application of trigger point dry needling Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in post-dry needling pain intensity before and after the intervention
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain
Measured: Baseline, immediately after, 24 hours after, 48 hours after and 72 hours after treatment
Secondary outcomes (3)
Changes in cervical related-disability before and after the intervention
The Neck Disability Index (NDI) will be used
Measured: Baseline and 72 hours after treatment
Changes in upper extremity related-disability before and after the intervention
The Shoulder Pain and Disability Index (SPADI) questionnaire will be used
Measured: Baseline and 72 hours after treatment
Changes in pressure pain sensitivity
Pressure pain threshold over the Trigger Point area will be assessed
Measured: Baseline, immediately after and 72 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start6 Jun 2018
- Primary completion5 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545880
- Sponsor's protocol ID
- URJC 2018-12
- Status last verified
- Aug 2018
- First submitted
- 22 May 2018
- Last updated
- 9 Aug 2018
- 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 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesiotaping on Post-Needling Soreness by Dry Needling on Active Trigger Points
- ClinicalTrials.gov ID
- NCT03545880
- Acronym / sponsor ID
- URJC 2018-12
- Conditions
- Mechanical Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 5 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 4 Jun 2018 (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.
Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Different therapeutic strategies targeting to decrease post-dry needling soreness need to be investigated. Since Kinesiotaping has been advocated for decreasing tone in the muscle tissues, it would be a potential intervention for this objective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping | Experimental | Other: KinesiotapingA Kinesiotaping will be provided over the upper trapezius muscle after the application of dry needling |
| Placebo | Placebo comparator | Other: PlaceboIndividuals will not perform any action after the application of trigger point dry needling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature
Key exclusion criteria (8 listed)
- any contraindication to dry needling
- whiplash injury;
- previous cervical surgery;
- cervical radiculopathy or myelopathy;
- diagnosis of fibromyalgia syndrome;
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 |
|---|---|---|
| KinesiotapingA Kinesiotaping will be provided over the upper trapezius muscle after the application of dry needling | Other | Kinesiotaping |
| PlaceboIndividuals will not perform any action after the application of trigger point dry needling | Other | Placebo |
Primary outcome
Changes in post-dry needling pain intensity before and after the intervention
Time frame: Baseline, immediately after, 24 hours after, 48 hours after and 72 hours after treatment
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain
3 secondary outcomes
Changes in cervical related-disability before and after the intervention
Time frame: Baseline and 72 hours after treatment
Changes in upper extremity related-disability before and after the intervention
Time frame: Baseline and 72 hours after treatment
Changes in pressure pain sensitivity
Time frame: Baseline, immediately after and 72 hours after treatment
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 9 Aug 2018.
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MECHANICAL BACK 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 Kinesiotaping in people with Mechanical Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 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 9 Aug 2018. 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 Spain. 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?
Changes in post-dry needling pain intensity before and after the intervention (time frame: Baseline, immediately after, 24 hours after, 48 hours after and 72 hours after treatment). 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 9 Aug 2018.